CLINICAL PRACTICE GUIDELINES oda] ABORTION November 2010 Brraricee ear tastececr ite Ue ese)Philippine Obstetrical and Gynecological Society (Foundation), Inc. CLINICAL PRACTICE GUIDELINES F on ABORTION November 2010 | | Task Force on Clinical Practice Guidelines on AbortionCopyright© 2010 Published by: Philippine Obstetrical and Gynecological Society (Foundation), Inc. POGS Building, No. 56 Malakas Street, Diliman, 1100 Quezon City P.O. Box 1252, Quezon City, P.O, 1152, Quezon City, Philippines Telephone Nos: (632) 921-7557, 921-9089, 435-2384, 435-2385 Fax: (632) 921-9089 E-mail address: pogs@platdsI.net Website: www.pogsinc.org ISBN 978-971-94602-9-9 All rights reserved. No part of this book may be reproduced in any for or by any means without prior permission from the publisher. Printed by: OVT - Graphic Line, Inc. (Printing & Publishing House) #23, 21 Street, Upper Plaza, West Rembo, Makati City Tel. Nos.: 882-4119 / 882-4120 + Telefax: 882-4120FOREWORD REGTA L. PICHAY, MD, PhD. President Philippine Obstetrical and Gynecological Society (Foundation), Inc. (POGS), 2010 In behalf of the officers and members of the Board of Trustees of the Philippine Obstetrical and Gynecological Society (Foundation), Inc. (POGS), I take pride in the launch, distribution and dissemination of the Clinical Practice Guidelines (CPG) in Abortion. This is the first edition of this publication. It comes at a time when the knowledge and evidences of common practices and recommendations have ripened towards its publication. It is with the work and diligent effort of the authors /contributors of each chapter/topic that the final version of this CPG is printed The POGS have been publishing and launching CPGs since last year 2009. In all, eight (8) were launched last year. In this year’s present CPG, the effort to write the recommendations and practice guidelines were in coherence with the reviews and plenary critiquing which the editorial board and the Task Force on Abortion adhered to. They were given ample time to synthesize and input comments from all sectors representing multi-level applications and time tested-practices with empiric and substantive bases. I commend the teamwork of the 2010 Committee on Clinical Practice Guidelines and the Task Force on Abortion. Your unselfish contribution to this body of work is a testimony of unwavering commitment and support toa major mission of the POGS.INTRODUCTION EFREN J. DOMINGO, MD, PhD. Chair, Committee on Clinical Practice Guidelines, 2010 The Clinical Practice Guidelines on Abortion is the First Edition of this Publication, 2010. The Philippine Obstetrical and Gynecological Society, (Foundation), Inc. (POGS), through the Committee on Clinical Practice Guidelines (CPG) initiated and led to completion the publication of this manual in plenary consultation with the Residency Accredited Training Hospitals’ Chairs and Training Officers, The Regional Board of Directors, The Board of Trustees, ‘The Task Force on Abortion and the Committee on CPG This publication represents the collective effort of the POGS in updating the clinical practice of Obstetrics and Gynecology, specifically on Abortion, and making it responsive to the most current and acceptable standard in this procedure. A greater part of the inputs incorporated in this edition are the contributions originating from the day-to-day academic interactions from the faculty of the different Residency-Accredited Hospitals in Obstetrics and Gynecology in the country This Clinical Practice Guideline on Abortion is envisioned to become the handy companion of the Obstetrician-Gynecologist in his/her day-to-day rendition of quality care and decision making in managing the Obstetric patient. This is also envisioned to provide the academic institutions in the country and in Southeast Asia updated information on diagnosis and management of Abortion as being practiced in the Philippines. Profound gratitude is extended to all the members of the POGS, the Chairs and Training Officers of the Residency-Training Accredited Institutions, the Regional Directors, The Task Force Reviewers /Contributors, The CPG Committee members, and the 2010 POGS Board of Trustees. Glomgre EFREN J. DOMINGO, MD, PhD iiBOARD OF TRUSTEES 2010 OFFICERS Regta L. Pichay, MD President Sylvia delas Alas-Carnero, MD Vice President Ditas Cristina D. Decena, MD Secretary Jericho Thaddeus P, Luna, MD Treasurer Gil S. Gonzales, MD Public Relations Officer BOARD OF TRUSTEES Efren J. Domingo, MD, PhD Virgilio B. Castro, MD Blanca C. de Guia-Fuerte, MD, MSCE. Raul M. Quillamor, MD Rey H. delos Reyes, MD Ma. Cynthia Fernandez-Tan, MD ivCOMMITTEE ON CLINICAL PRACTICE GUIDELINES. Efren J. Domingo, MD, PhD Editor in Chief ‘MEMBERS ‘Anne Marie C. Trinidad, MD Ma. Vietoria V. Torres, MD Lisa T. Prodigalidad-Jabson, MD Rommel Z. Duefias, MD MANAGING EDITOR Ana Victoria V. Dy Echo, MD TECHNICAL STAFF ASSISTANT ‘Ms. Emiliana C. Enriquez ‘TASK FORCE ON ABORTION Rommel Z. Duefias, MD Chair Members Sybil Lizanne R. Bravo, MD Maria Lourdes B. Coloma, MD Lorina Q. Esteban, MD ‘Aida V. San Jose, MD Florentina A. Villanueva, MD Ma Corazon N. Zaida-Gamilla, MD ‘TASK FORCE REVIEWERS AND PLENARY REVIEWERS Rainerio $. Abad, MD Ma. Flores Adiong, MD Almira Amin-Ong, MD. Imelda 0. Andres, MD Ruth Jinky Aposaga, MD Prudence V. Aquino, MD ‘Nurlinda Arumpac, MD Ricardo Braganza, MD Maria Nelvez.Candilario, MD Grace D. Caras, MD Abigail Elsie D. Castro, MD Ma, Theresa Cedullo, MD Ma.Cherrie Climaco, MD Antonio Cortez, MD Lara David-Bustamante, MD Macrina A. De Guzman, MD Grace D. delos Angeles, MD Rodante P. Galiza, MD Gil S. Gonzales, MD Maribel Hidalgo-Co, MD. Jennifer Jose, MD May N. Hipolito, MD Rosemarie R. Hudencial, MD Humildada Asumpta igana, MD Margarette Lavalle, MD Lourdes Ledesma, MD Jericho Thaddeus P. Luna, MD Mae. Teresa A. Luna, MD Ma, Cecilia Maclang, MD—-Marilou Mangubat, MD Corazon B. Mata, MD Jocelyn Z. Mariano, MD _—_—Rudie Frederick B. Mendiola, MD, Marites Mendoza, MD Suzette Milat, MD Manuel S. Ocampo, MD CristiaS. Padolina, MD Mary Christine F. Palma, MD _ Belen Pantangco-Rajagukguk, MD Gladys Pelicano, MD Regia L. Pichay, MD Sarah Pingol, MD Kenet Prado, MD Ma, Carmen H. Quevedo, MD_ Rico E. Reyes, MD Ricalyna Rivera, MD Bella G Rodriguez, MD" Pura Rodriguez-Caisip, MD Alice Salvador, MD Jean Marie Salvador, MD Esmarliza Tacud-Luzon, MD Patricia L. Tan, MD Ma. Theresa B. Tenorio, MD Jean Anne B. Toral, M Florentina A. Villanueva, MD_ Julieta Villanueva, MD_ Faith Villaruiz, MD. Marilou Viray, MD Regina P, Vitriolo, MD Amarylis Digna A. Yazon, MD Regional Directors Betha Fe M. Castillo, MD (Region 1) Noel C. de Leon, MD (Region 2) Concepcion P. Argonza, MD (Region 3) Emesto $. Naval, MD. (Region 4) Diosdado V, Mariano, MD (Region 44 NCR) Cecilia Valdes-Neptuno, MD (Region 5) Evelyn R. Lacson, MD (Region 6) Belinda N. Panares, MD (Region 7) FeG Metin, MD (Region 8) Cynthia A. Dionio, MD (Region 9) Jana Joy R. Tusalem, MD (Region 10) Amelia A. Vega, MD (Region 11)DISCLAIMER, RELEASE AND WAIVER OF RESPONSIBILITY This is the Clinical Practice Guid November 2010. This is the publication of the Philippine Obstetrical and Gynecological Society, (Foundation), Inc. (POGS). This is the ownership of the POGS, its officers, and its entire membership. The obstetrician gynecologist, the general practitioner, the patient, the student, the allied medical practitioner, or for that matter, any capacity of the person or individual who may read, quote, cite, refer to, or, acknowledge, any, or part, or the entirety of any topic, subject matter, diagnostic condition or idea/s willfully release and waive all the liabilities and responsibilities of the POGS, its officers and general membership, as well as the Committee on the Clinical Practice Guidelines and its Editorial Staff in any or all clinical or other disputes, disagreements, conference audits/controversies, case discussions/critiquing, The reader is encouraged to deal with each clinical case as a distinct and unique clinical condition, which will never fit into an exact location if reference is ‘made into any or all part/s of this CPG. The intention and objective of this CPG is to serve as a guide, to clarify, to make clear the distinction. It is not the intention or objective of this CPG to serve as the exact and precise answer, solution and treatment for clinical conditions and situations. It is always encouraged to refer to the individual clinical case as the one and only answer to the case in question, not this CPG, It is hoped that with the CPG at hand, the clinician will find a handy guide that leads to the clue, to a valuable pathway that leads to the discovery of clinical tests leading to clinical treatments and eventually recovery. In behalf of the POGS, its Board of Trustees, the Committee on The Clinical Practice Guidelines, 2010, this CPG is meant to make each one of us a perfect image of Christ, the Healer, ies (CPG) on Abortion First Edition, viCPG ON ABORTION TOPICS / CONTENTS / AUTHOR/S I. Spontaneous Abortion: Definition, Clinical Manifestations and Diagnosis .. ‘Aida V. San Jose, MD and Florentina A. Villanueva, MD I Spontaneous Abortion: Management ‘Ma. Corazon N. Zaida-Gamilla, MD and ‘Maria Lourdes B. Coloma, MD Til. Recurrent Abortion .. ‘Aida V. San Jose, MD and Florentina A. Villanueoa, MD IV. Unsafe Abortion Sybil Lizanne R. Bravo, MD and Lorina Q. Esteban, MD V. Appendices The Revised Penal Code of the Philippines ..... = 37 Levels of Evidence and Grades of Recommendation -.-.-.-39 vii1. a5 4, SPONTANEOUS ABORTION Definition, Clinical Manifestations and Diagnosis Aida V. San Jose, MD and Florentina A. Villanueva, MD. ‘Abortion is any loss of a fetus that is less than 20 weeks age of gestation (AOG), or that which weighs less than 500 g. orting Statement This is based on definitions used by the National Center for Health Statistics, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO). Alternately, abortion is a pregnancy loss under 24 weeks. (Level Il, Grade C) Supporting Statement Since institutions have reported survival of infants at 24 weeks, and no definition to cover 21-23 weeks AOG, a slight modification in the definition is recommended? ‘The medical term which should be used in explaining this condition to patients should be “Miscarriage”. Supporting Statements The term “abortion” may give the woman a negative self-perception which may worsen her sense of failure, shame, guilt and insecurity in spontaneous abortions. In 2005, the European Society for Human Reproduction (ESHRE) Special Interest Group for Early Pregnancy (SIGEP) published a revised nomenclature for use in early pregnancy loss in order to improve clarity and consistency of terms.’ The terms in Table 1 are recommended. In the subsequent entries of this clinical practice guideline (CPG), the term “Miscarriage” and “Abortion” refers to the same clinical entity.‘Table 1. Terminologies Previous Term Recommended Term Spontaneous abortion caring “Threatened abortion “Threatened miscarriage Tevitable abortion Tnevitable miscarriage Incomplete abortion Tncomplete miscarriage — Complete abortion ‘Complete miscarriage Sted abortion anembryonie pregnancy Tblighied | Missed miscarriage / early fetal ‘ovum (these reflect different stages in the same demise / delayed miscarriage / silent process) miscarriage Septic abortion Miscarriage wit infection (Sepsis) Recurrent abortion ‘Recurrent misearriage Causes of Abortion 1. Embryonic abnormalities Chromosomal abnormalities (e.g. Trisomy) Il. Maternal factors i Chronic maternal health factors: Maternal insulin-dependent diabetes mellitus (IDDM) Severe hypertension Renal disease Systemic lupus erythematosus (SLE) Hyperthyroidism Acute maternal health factors: Infections (e.g., rubella, cytomegalovirus [CMV], Mycoplasma, reaplasma, Listeria, toxoplasmal infections) Trauma Severe emotional shock II, Other factors that may contribute to abortion Exogenous factors: Alcohol Tobacco Cocaine and other Anatomie factors. Congenital anatomic lesions include millerian duct anomalies (e; septate uterus, diethylstilbestrol [DES)-related anomalies) and anomal of the uterine artery ‘Acquired lesions include intrauterine adhesions (i.e. synechiae leiomyoma, and endometriosis it drugs 2Endocrine factors Luteal phase insufficiency (i.e. abnormal corpus luteum function with insufficient progesterone production), hypothyroidism, hypoprolactinemia, poor diabetic control, and polycystic ovarian syndrome Infectious factors: Bacterial, viral, parasitic, fungal, and zoonotic Immunologic factors: Antiphospholipid antibody syndrome (APAs) Miscellaneous factors. Environment, drugs, placental abnormalities, medical illnesses, and male- related causes Clinical Manifestations Spontaneous abortion can be classified clinically into the following: threatened, inevitable, incomplete, missed, septic and recurrent - also termed recurrent pregnancy loss. 1. Threatened Miscarriage: Vital signs should be within normal limits unless infection is present or hemorthage has caused hypovolemia Pregnant woman presents with bloody vaginal discharge with or without hypogastric pain, with or without low back pain, The abdomen usually is soft and nontender. Pelvic examination reveals a closed internal cervical os. The bimanual examination is unremarkable Supporting Statements This may develop in 20-25% of women during early gestation and may persist for days or weeks. According to Tongson, et. al., approximately half of these pregnancies will abort, although the risk is substantially lower if fetal cardiac activity is visualized. In 2006, Eddleman stated that the bleeding during the current pregnancy was the most predictive risk factor for pregnancy loss. Authors mentioned that even if abortion does not follow early bleeding, these fetuses are at increased risk for preterm delivery, low birthweight, and perinatal death.! 2. Inevitable Miscarriage: The sudden discharge of fluid is accompanied or followed by vaginal bleeding: This vaginal bleeding is often associated with abdominal pain and cramping, 33. ‘Supporting Statements Gross rupture of the membranes, evidenced by leaking amnionie fluid in the presence of cervical dilatation, signals almost certain abortion. If, however, the gush of fluid is accompanied or followed by bleeding, pain, or fever, abortion should be considered inevitable, and the uterus emptied Vaginal bleeding is accompanied by dilatation of the cervical canal. Bleeding is usually more severe than with threatened miscarriage.’ Incomplete Miscarriage: On pelvic examination, products of conception may be partially present in the uterus, may protrude from the external os, or may be present in the vagina. The cervical os may appear dilated and effaced, or it may be closed. Vaginal bleeding may be intense and accompanied by abdominal pain. On bimanual examination may reveal an enlarged and soft uterus. ‘Summary of Evidence Before 10 weeks, the fetus and placenta are commonly expelled together, but later they are delivered separately. Bleeding ensues when the placenta, in whole or in part, detaches from the uterus. Hemorrhage from incomplete abortion of a more advanced pregnancy is occasionally severe but rarely fatal.! Complete Misearriage: Bleeding and pain have subsided. On pelvic examination, the cervix should be closed, and the uterus should be contracted. ‘Supporting Statements Patients may present with a history of bleeding, abdominal pain, and tissue passage. By the time the abortion is complete, bleeding and pain usually have subsided. Diagnosis may be confirmed by observation of the aborted fetus with the complete placenta, although caution is recommended in making this diagnosis without ultrasound because it can be difficult to determine if the abortion is complete. Missed Miscarriage — early pregnancy failure: Vital signs usually are in normal limits. Abdominal examination may or may not reveal a palpable uterus. If palpable, the uterus usually is small for the presumed gestational age. Fetal heart tones are inaudible or unseen on sonogram. The cervical os is closed upon pelvic examination. The uterus may feel soft and enlarged.Supporting Statements: Because spontaneous abortions are almost always preceded by embryo or fetal death, most were correctly referred to as “missed.” In the typical instance, early pregnancy appears to be normal, with amenorthea, nausea and vomiting, breast changes, and uterine growth. A fter embryonic death, there may or may not be vaginal bleeding or other symptoms of threatened abortion. Thus, the dead products of conception were retained for days, ‘weeks, or even months in the uterus with a closed cervical ‘os! Diagnosis 1, Clinical history: Patients with spontaneous abortion usually present with vaginal bleeding, abdominal pain, or both. ‘Supporting Statements Vaginal bleeding may vary from slight spotting to a severe life- threatening hemorrhage. The patient’s history should include the number of pads used. Heavy bleeding in the first trimester, particularly when associated with abdominal pain, is associated with higher risk of miscarriage. Presence of blood clots or tissue may be an important sign indicating progression of spontaneous miscarriage. Abdominal pain is usually located in the suprapubic area or in one or both lower quadrants. Pain may radiate to the lower back, buttocks, genitalia, and perineum. 2. Physical examination should focus on detemining the source of bleeding. Supporting Statements The following should be included in the determining the source of bleeding-blood from cervical os, intensity of bleeding, presence of clots or tissue fragments, cervical motion tenderness, status of internal cervical 08 (open indicates inevitable or possibly incomplete miscarriage; closed indicates threatened miscarriage), uterine size and tenderness, as well as adnexal tenderness or masses." 3. Ultrasound: With the introduction of transvaginal ultrasound (TVS), longitudinal assessment of early pregnancy development can be made in terms of viability and growth? 5Supporting Statements Ultrasound plays a major role in: maternal reassurance, where fetal Cardiac activity is seen pivotal in the assessment of early pregnancy complications, such as vaginal bleeding. However, there are limits to ultrasound resolution of normal early pregnancy development. The most common TVS finding prior to 35 days was a pregnancy of unknown location (PUL) or an intrauterine pregnancy of uncertain viability CPUVD), from 35 to 4 days an early intrauterine pregnancy of uncertain, Viability and from 42 daysia viable intrauterine pregnancy, Miscarriage could only be diagnosed on initial TVS after 35 days.4A diagnosis of “anembryonie pregnancy” or “early embryonic demise” or _Embry0 loss” should not be made ifthe visible crown-rump length (CRL) is less than 6 mm, as only 65% of normal embryos will display cardiac activity? Repeat TVS examination after at least a week, showing identical features and/or the presence of fetal bradycardia, is strongly suggestive of impending miscarriage? When the fetus has clearly developed and the fetal heart is absent, the term ‘missed miscarriage’ should be replaced by “delayed miscarriage”. The following findings on TVS which are suggestive of possible pregnancy failure, or pregnancy of questionable viability:$ * Failure to visualize an intrauterine pregnancy by TVS when the B subunit human chorionic gonadotropin (B-hCG) level js between 1000-2000 mIU/mL ~also known as discriminatory level of B-hCG * Failure to detect.a yolk sae when the mean sac diameter (MSD) is >8mm + Failure io detect cardiac activity when the MSD is > 16 mm Ifthe MSD fails to inerease in size by atleast 0.6 mnvday * Absent cardiac activity if the CRL > § mm * When the difference between CRL and MSD is <5 mm, this is oligohydramnios. The incidence of spontaneous abortion in these cases is 80-94%, even if there is cardiac activity * Yolk sac > 6 mm may be predictive of pregnancy fetus of a mother with insulin-dependent diabetes * Yolk sacs which are abnormally shaped, calcified, echogenic or double (with vitelline cyst) * Visible amnion when the CRL-<7 mm * Visible amnion > 6 mm without an embryo * Fetal bradycardia defined as fetal heart rate (FHR) < 100 beats Per minute (bpm) before 6.2 weeks AOG and < 120 bpm between re, or a 6©.3-7 weeks should be investigated because this might mean peganancy failure or chromosomal and structural anomalies (ex. trisomy 18 and triploidy) * Fetal tachycardia at 10-14 weeks is associated with trisomy 21, trisomy 13, and Turner syndrome 4. Serum B-hCG: For PUL or IPUVI, serial serum B-hCG assay is important.‘ (Level I1I, Grade B) upporting Statements B-hCG is detectable in the serum of approximately 5% of patients 8 days after conception and in more than 9894 of patients by day 11.4 At 4 weeks AOG (18-22 days posteonception), the dimer and B-hCG is important in the monitoring of early complicated pregnancies that have yet to be documented as viable and/or intrauterine. Failure to achieve the projected rate of rise may suggest an ectopic Pregnancy or spontaneous abortion. Serial sera B-hCG assay is Particularly useful in the diagnosis of asymptomatic ectopic pregnancy.? Supporting Statement TVS, serial serum B-hCG levels, and progesterone may all be required in order to establish a definite diagnosis.? References 1 Cuningham G, et al (Eds). “Abortion” In: Williams Obstetrics. McGraw-Hill Companies, Inc. 2010. 2. Royal College of Obstetricians and Gynaecologists (RCOG). The management of carly Pregnancy loss. Royal College of Obstetricians and Gynaecologists (RCOG) Guideline No. 25. 2006;18,3, 10. MW. 12. European Society of Human Reproduction and Embryology (ESHRE) Special Interest Group for Early Pregnancy (SIGEP). Updated and revised nomenclature for description of early pregnancy events. Human Reproduction 2005;20(111):3008-3011. Bottomley C, Van Belle V, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T. ‘The optimal timing of an ultrasound scan to assess the location and viability of an early pregnancy. Human Reproduction 2009;24(8):1811-1817. Callen P (Ed). “Ultrasound evaluation during the first trimester” In: Ultrasonography in Obstetrics and Gynecology, 5* edition. 2008. Gaufberg SV. Early pregnancy loss. Contributor Information and Disclosures. Updated: April 16, 2010. Shields AD. Pregnancy diagnosis. Contributor Information and Disclosures. Updated: April 20, 2009. Stubblefield PG, Grimes DA. Septic abortion. New Engl J Med 1994;331(5): 310- 314, Broklehurst TJ, et al. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). Br Med J 2006;332:1235-1240. Finkielman JD, De Feo FD, Heller PG, Afessa B. The clinical course of patients with septic abortion admitted to an intensive care unit. /ntensive Care Med 2006:30(6). Davis VJ. Induced abortion guidelines. SOGC Clinical Practice Guidelines 2006;184. Chan FY, Ghosh A, Tang M, Ng J. Ultrasound in prenatal diagnosis: use and pitfalls. J Hong Kong Med Assoc 1991:43(2).SPONTANEOUS ABORTION Management Ma. Corazon N. Zaida-Gamilla and Maria Lourdes B. Coloma ier Threatened Miscarriage 1. There is no evidence to support bed rest, progestogens, and vitamin supplementation as advantageous in the prevention of miscarriage. (Level I, Grade A) Supporting Statements The review of Aleman, et.al. netted only 2 studies including 84 women, These showed no statistically significant difference in the risk of ‘miscarriage in the bed rest group versus the no bed rest group (placebo or other treatment) (relative risk [RR] 1.54, 95% confidence interval {Cl} 0.92-2.58). Neither bed rest in hospital nor bed rest at home showed a significant difference in the prevention of miscarriage, There Was a higher risk of miscarriage in those women in the bed rest group than in those in the human chorionic gonadotropin (hCG) therapy group with no bed rest (RR 2.50, 95% CI 1.22-5.11). However, the number of participants is too small to provide evidence of high quality towards a policy of bed rest in order to prevent miscarriage in women with confirmed fetal viability and vaginal bleeding in first half of Pregnancy.! Similarly, 17 randomized and quasi-randomized trials comparing One or more vitamins with either placebo, other vitamins, no vitamins oF other interventions, prior to conception, periconceptionally or in carly pregnancy (less than 20 weeks age of gestation [AOG]) showed that taking vitamin supplements, alone or in combination with other vitamins, prior to pregnancy or in early pregnancy, does not prevent women experiencing miscarriage or stillbirth? The meta-analysis by Haas, et. al., of 15 trials including 2114 women regardless of gravidity and number of previous miscarriages, showed no statistically significant difference in the risk of miscarriage between progestogen and placebo or no treatment groups (Peto odds [Peto OR] 0.98; 95% CI0.78-1.24) and no statistically significant. difference in the incidence of adverse effect in either mother or baby.) 9a; Progestogen may be beneficial in women who have had 3 or more prior miscarriages, (Level J, Grade A) Supporting Statements In the subgroup analysis by Haas, et. al. of 3 trials involving women who had recurrent miscarriages (3 or more consecutive miscarriages), progestogen treatment showed a statistically significant decrease i miscarriage rate compared to placebo or no treatment, No statistically significant differences were found between the route of administration of progestogen (oral, intramuscular, vaginal) versus placebo or no treatment. So while there is insufficient evidence to support routine use of progestogen to prevent miscarriage in early to mid-pregnancy, there seems to be evidence of benefit in women with several previous miscarriages.” Incomplete Miscarriage Pa Surgical evacuatio} (Level I, Grade A) acceptable as standard and traditional practice. Expectant management is also an acceptable alternative but it carries higher risk of incomplete miscarriage and bleeding, and subsequent need for surgical emptying of the uterus. (Level J, Grade A) Supporting Statements Multiple randomized controlled trials (RCTs) and cohort studies reviewed by Butler, et.al. have demonstrated that more than 80% of women with a first trimester spontaneous abortion have complete natural passage of tissue within 2 to 6 weeks with no higher complication rate than that from surgical intervention.‘ This is the basis for so-called expectant management, Obviously, surgical evacuation is the management of choice in women experiencing spontaneous abortion with unstable vital signs, uncontrolled bleeding, or evidence of infection. ‘The miscarriage treatment trial (MIST) saw that the incidence of gynecological infection after surgical, expectant, and medical management of first trimester miscarriage is low (2-3%) and no evidence exists of a difference by the method of management.’ However, significantly more unplanned admissions and unplanned surgical curettage occurred after expectant management and medical management than after surgical management. 10Manual vacuum aspiration (M\ comparable advantages. (Level VA) and shar, P curettage have 1, Grade A) Supporting Statements Forna, et.al. reviewed trials comparing the safety and effectiveness 1of those procedures.’ MVA was associated with statistically significantly decreased blood loss (-17 ml weighted mean difference [WMD], 95% Cl 24 to-10 ml), less pain (RR 0.74, 95% C1 0.61-0. 90), and shorter duration of procedure (-1.2 minutes WMD, 95% CI -1.5 to -0.87 minutes), than sharp curettage, in the single study that evaluated these outcomes. Complications such as uterine perforation and other morbidity were rare and the sample sizes of the trials were not large enough to evaluate small or moderate differences, Similarly, the 11 trials studied by Kulier, et. al. do not indicate overall benefits of one over the other method.’ MVA can be used for early first trimester surgical abortion, but may be more difficult when used after the 9° week AOG. A retrospective study by Milingos, et. al. of 246 patients who were scheduled to undergo MVA for first trimester early fetal demise and first and mid-trimester incomplete miscarriage demonstrated 94.7% (232/245) efficacy of the procedure. Incomplete uterine evacuation was seen in 5.3% (13/245) patients." 4. Antibiotics are to be used when indicated. (Level J, Grade A) Supporting Statements Antibiotics are indicated management where there are signs of infection in a case of incomplete abortion, especially when unsafe abortion is suspected. In contrast, the effectiveness of routine use of antibiotics prior to evacuating the uterus in cases of incomplete abortion has not been supported by adequate studies. May, et. al. cite the paucity of trials comparing a policy of prophylaxis vs. no prophylaxis." The one study that qualified for their review showed no differences in postabortal infection rates with routine prophylaxis or control. Poor compliance with antibiotic treatment was also noted. 5. Hysterotomy is performed in situations where: (a) myometrium is too thin, (b) cervix is blocked by a fibroid or other uterine anomalies, Missed Miscarriage 1, Cervical preparation decreases the length of the uterine evacuation process. (Level Il, Grade A) Supporting Statements Preparing the cervix prior to surgical abortion is intended to make the 12provedure both easier and safer. Cervical preparation decreases the length of the abortion procedure; this may become increasingly important with increasing gestational age, as mechanical dilation at later gestational ages takes longer and becomes more difficult. Available data do not suggest a Bestational age where the benefits of cervical dilation outweigh the side effects, including pain, that women experience with cervical ripening Procedures or the prolongation of the time interval before procedure completion. Adjunets to surgical procedures consisting of laminaria and other dilators, intraoperative real time ultrasound and intracerviesl vasopressin are acceptable practices. (Level J, Grade A) Supporting Statements Options for cervical preparation include osmotic dilators and Pharmacologic agents. Many formulations and regimens are available, and recommendations from professional organizations vary for the use of Preparatory techniques in women of different ages, parity or gestational age of the pregnancy. Evidence noted below are from third trimester rather than first trimester gestations. Mechanical methods used in missed abortion were developed originally for use in the third trimester to ripen the cervix or to induce labor. Thi. includes a variety of catheters and laminaria tents inserted into the cervical canal or into the uterus. They have been replaced largely by pharmacologic agents over time. Boulvain, et. al. reviewed some 45 studies to determine the effects of mechanical methods for third trimester cervical ripening or induction of labor in comparison with placebo/no treatment, prostaglandins (vaginal, intracervical, misoprostol) and oxytocin.'> The evidence was however insufficient to evaluate the effectiveness, in terms of likelihood of vaginal delivery in 24 hours, of mechanical methods compared with placebo/no (eatment or with prostaglandins. Compared with prostaglandins Cintracervical, intravaginal or misoprostol), the risk of hyperstimulation was reduced. Compared to oxytocin in women with unfavorable cervix, mechanical methods reduce the risk of cesarean section. There is no evidence to support the use of extra-amniotic infusion, Fifty-one studies examined by Kapp, et. al. showed that current methods of cervical ripening are generally safe, although efficacy and side effects between methods vary.'® Adverse events such as cervical laceration or uterine perforation are uncommon overall in this body of evidence and no published study has investigated whether cervical 13preparation impacts these rare outcomes. Mifepristone 200 mg, osmotic dilators and misoprostol 400 mg, administered either vaginally or sublingually, are the most effective methods of cervical preparation. ‘When compared to placebo, misoprostol (400-600 mg given vaginally or sublingually), gemeprost, mifepristone (200 or 600 mg), prostaglandin E and F2 cc (2.5 mg administered intracervically) demonstrated larger cervical preparation effects. When misoprostol was compared to gemeprost, misoprostol was more effective in preparing the cervix and was associated with fewer gastrointestinal side effects. For vaginal administration, administration 2 hours prior was less effective than administration 3 hours prior to the abortion. Compared to oral misoprostol administration, the vaginal route was associated with significantly greater initial cervical dilation and lower rates of side effects. However, sublingual administration 2-3 hours prior to the procedure demonstrated cervical effects superior to vaginal administration. The use of uterotonics in the form of oxytocin has been well established as standards in the pharmacologic management of missed miscarriage. (Level I, Grade A) Supporting Statements Prior to the introduction of prostaglandin agents oxytocin was used as acervical ripening agent as well. In 58 studies involving 11,129 women analyzed by Kelly, et. al. noted that oxytocin alone reduced the rate of unsuccessful vaginal delivery within 24 hours when compared with expectant management (8.3% versus 54%, RR 0.16, 95% CI 0.10-0.25) but the cesarean section rate was increased (10.4% versus 8.9%, RR 1.17, 95% CI 1.01-1.36)."” On the other hand, comparison of oxytocin alone with either intravaginal or intracervical prostaglandin reveals that the prostaglandin agents probably overall have more benefits than oxytocin alone. In the Philippines, misoprostol is not approved for therapeutic use in miscarriage. (Level II, Grade C) Supporting Statements When misoprostol (600 mg oral or 800 mg vaginal) was compared to mifepristone (200 mg administered 24 hours prior to procedure), misoprostol had inferior cervical preparatory effects. Compared to day- prior laminaria tents, 200 or 400 mg vaginal misoprostol showed no 14differences in the need for further mechanical dilation or length of the Procedure; similarly, the osmotic dilators Lamicel and Dilapan showed no differences in cervical ripening when compared to gemeprost, although gemeprost had cervical effects which were superior to laminaria tents. Older prostaglandin regimens (sulprostone, prostaglandin E2 and F2 01) were associated with high rates of gastrointestinal side effects and unplanned pregnancy expulsions. Few studies reported women’s satisfaction with cervical preparatory techniques. Dilation and evacuation is the safest technique for mid-trimester abortion, especially when performed at 13-16 weeks. Laminaria tents are IeRtin place overnight, and the procedure is performed under paracervical block with intravenous sedation using low doses of diazepam and fentany Evacuation is by means of large-bore vacuum cannula system and large ovum forceps, General anesthesia is avoided because it increases the risk of perforation and hemorrhage. Adjuncts to dilatation and evacuation are intraoperative real-time ultrasound, intracervical vasopressin, two days treatment with laminaria tents, and Hern’s technique combining laminaria with intra-amniotic infusion of urea prior to dilatation and evacuation. References 1, Aleman A, Althabe F, Belizan J, Bergel E. Bed rest during pregnancy for preventing miscarriage. Cochrane Database Syst Rev 2003. 2. Rumbold A, Middleton P, Crowther CA. Vitamin supplementation for preventing miscarriage. Cochrane Database Syst Rev 2005, Issue 2. Art. No.: CD004073. DOI: 10.1002/14651858.CD004073.pub2. 3. Haas DM, Ramsey PS. Progestogen for preventing miscarriage. Cochrane Database Syst Rev 2008. 4. Butler C, Kelsberg G, St. Anna L, Crawford P. Clinical inquiries: How longis expectant ‘management safe in first trimester miscarriage? J Fam Pract 2005;54(110):889-90. 5. Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). B14/. 2006 May 27;332(7552):1235-40. Epub 2006 May 17. 6. Nanda K, Peloggia A, Grimes D, Lopez L, Nanda G. Expectant care versus surgical treatment for miscarriage. Cochrane Database Syst Rev 2007, Issue 4. Art, No.: €D003518. DOI: 10.1002/14651858.CD003518.pub2 7. Forna F, Gilmezoglu, AM. Surgical procedures to evacuate incomplete abortion. Cochrane Database Syst Rev 2001, Issue 1. 8. Neilson JP, Gyte GM, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage (less than 24 weeks). Cochrane Database Syst Rev.2010 Jan 20;(1):CD007223, 9. Prager, Oyer. Second trimester surgical abortion. Clinical Obstet Gynecol 2009;52(2). 1510. me 12 Kulier R. Geneva Foundation for Medical Education and Research. March 2003.The Cochrane Collaboration. Wiley, 2010. Kulier R, Cheng L, Fekih A, Hofmeyr GJ, Campana A. Surgical methods for first trimester termination of pregnancy. Cochrane Database Syst Rev 2001, Issue 4, Art No.: CD002900. DOI: 10.1002/14651858.CD002900. 1g0s DS, Mathur M, Smith NC, Ashok PW. Manual vacuum aspiration: a safe alternative for the surgical management of early pregnancy loss. B/OG 2009 ‘Augs116(9):1268-71. Stubblefield PG. Surgical techniques of uterine evacuation in first-and second:-trimester abortion. Clin Obstet Gynaecol. 1986 Mar;13(1):53-70 |. May W, Gtlmezoglu AM, Ba-Thike K. Antibiotics for incomplete abortion, Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001779, Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochhrane Database Syst Rev. 2001;(4):CD001233. Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev 2010, Issue 2. Art. No.: CD007207. DOI: 10.1002/14651858.CD007207,pub2 . Kelly AJ, Tan B. Intravenous oxytocin alone for cervical ripening and induction of labor. Cochrane Database Syst Rev. 2009;(4):CD003246. . Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003246, 16RECURRENT ABORTION Aida V. San Jose, MD and Florentina A. Villanueva, MD Definition Recurrent spontaneous abortion or recurrent pregnancy loss (RPL) is defined as three or more consecutive pregnancy losses before 20 weeks from the last normal period (LMP) or with fetal weights less than 500 grams.’ Most women with recurrent miscarriage have embryonic or early fetal loss, and the minority of losses are after 14 weeks.' 2. For patients with history of RPL, the risk of subsequent pregnancy loss is estimated to be: 24% - after 2 clinically recognized losses 30% - after 3 losses 40-50% - after 4 losses' Although the definition includes three or more miscarriages, many agree that evaluation should at least be considered following two consecutive losses. This is because the risk of subsequent loss after two successive miscarriages is similar to that following three losses — approximately 30%. Causes Parental Factors 1. Parental chromosomal abnormalities account for only 2-4% of RPL, but karyotyping evaluation of both parents remain a critical part of evaluation.? (Level II, Grade B) The chances of carrier status for a balanced structural chromosome abnormality are dependent on the maternal age at which the second smiscarriage took place, the number of miscarriages, and whether or not the parents or siblings of the couple with the recurrent miscarriage have had two or more miscarriages.* (Level III, Grade B) 17Cytogenetic Factors 3. It is advised to carry out karyotyping using Table 1. All women aged up to 34 years at the time of the second miscarriage (this also applies to women with more miscarriages) should be offered karyotyping. 4. Women aged between 34 and 39 years atthe time of the second miscarriage should be offered karyotyping on the basis of the number of miscarriages experienced by them personally and the occurrence of two or more miscarriages in first degree family members, i., parents or siblings. In women of 39 years old or older at the time of the. second miscarriage there is no need to offer karyotyping regardless of the number of miscarriages. ‘Table 1: Recommendation for Investigations in Couples with Recurrent Miscarriage De Don't | _Evllence Level Karyoryping of both partners ‘Woman <34 years okt at the time oF = 5 miscarriage Woman 3439 yearsoldaiihetme ok2™ — | Dependent on Family miscaringe history and number of miscarriages Woman > 39 years dat the ime o?2™ miscarriage (respective ofthe number of siscartiages) Karyotyping of concepts Progesterone in luteal phase Thyroid function Glucose Lupus antioagulant (LAC), anicardiolipin antibody (ACA), immunoglobulin G (Ig) x and immunoglobulin M (1aM) “Ant-thrombin (AT), protein C, protein S, Factor V Leiden, prothrombin 20210 GIA xt B mutation, and Factor VI Random hamoeysteine x zB Determine body mass index (BMI x B Determine lifestyle (smoking / alcohol coffee) * x B ‘Assessment of thrombophilia factors should take place if there is venous thromboembolism in the woman's medical history and/or if there is a first-degree family member with a known thrombophilia defect as well as a venous thromboembolism. * | efoe| lof] o 5. The frequency of cytogenetically abnormal miscarriage tissue from couples with recurrent miscarriage does not differ from that of an unselected population with sporadic miscarriage. (Level III, Grade C) 186. Because numerical chromosome abnormalities found in a product of conception after miscarriage do not carry an increased risk of another miscarriage, karyotyping the product of the conception does not add value to the process of finding the underlying factors in a miscarriage and furthermore has no therapeutic effects? Endocrine Factors 7. Corpus luteum insufficiency: There is insufficient evidence in a subsequent pregnancy after recurrent miscarriage to justify treatment with progesterone or B-hCG? (Level II-1, Grade C) Supporting Statements Research has been carried out into the question as to whether women with recurrent miscarriage who were given B-hCG or progesterone had a reduced chance of a miscarriage compared to those receiving a placebo or no treatment. From an analysis of four randomized trials, it appeared that prescribing B-hCG reduced the chances of a miscarriage, but this conclusion is mainly based on the results of two methodologically weak studies. The two methodologically superior studies show no difference in the risk of miscarriage. 8. Thyroid dysfunction: Assessment of thyroid status in women with recurrent miscarriage is not indicated. (Level IJ-2, Grade B) ‘Supporting Statements The prevalence of thyroid dysfunction among women with thyroid disease is low (1-2%). Thyroid disease is not more prevalent in women with recurrent miscarriage than it is in the general population. In case- control studies, an increased risk of recurrent miscarriage has been found in women with thyroid autoantibodies, but it is unclear whether there is a causal link? 9. Diabetes Mellitus: Screening for diabetes mellitus in asymptomatic ‘women because of recurrent miscarriage is not recommended.* (Level II, Grade B) Supporting Statements The prevalence of diabetes mellitus in women with recurrent 1910. i. miscarriage is low (<196). It has been shown that women with diabetes mellitus and high HbA Ic levels in the first trimester have an increased risk of miscarriage, and that the risk for well-controlled patients is not increased. Maternal Infection: Infection of the reproductive tract with bacterial, Viral, parasitic, zoonotic, and fungal organisms has been linked theoretically to pregnancy loss.' (Level I1-1, Grade A) Supporting Statements One prospective comparison trial involving 70 patients with RPL reported no elevations in any markers for present or past infection with C trachomatis when compared with controls. In contrast, a very large, prospective trial has demonstrated a link between the detection of bacterial vaginosis and history of second-trimester pregnancy loss among 500 patients with RPL. Herpes simplex virus (HSV) and human cytomegalovirus (CMV) can directly infect the placenta and fetus. The resulting villitis and related tissue destruction may disrupt pregnancy." "Another theoretic possibility is that infection-associated early pregnancy loss may result from immunologic activation that occurs in Fesponse to pathologie organisms. A large body of evidence supports the role of this mechanism in adverse events that occur later in gestation, such ts intrauterine growth restriction, premature rupture of membranes, and preterm birth. Alternatively, mechanisms that protect the fetus from utoimmune rejection also may protect virally infected placental cells from recognition and clearance.* Uterine Factors: Congenital uterine anomalies are associated with recurrent miscarriages. (Level IJ-3, Grade B). ‘Supporting Statements Comparative research in women with recurrent miscarriage and @ control group show more congenital uterine anomalies inthe first group. “The septate uterus, in particular, is associated with early miscarriage Uterine septum resection should only take place in a randomized trial Retrospective cohort studies suggest a reduced chance of implantation and an increased risk of miscarriage in in-vitro fertilization (IVF) patients ‘vith a submucosal fibroid but no association with recurrent miscarriage has been shown? 20Patients with RPL should be investigated for id antibody syndrome (APAS). (Level II, Grade A) APAS is characterized by recurrent miscarriage, pregnancy related morbidity (pre-eclampsia and growth retardation), and/or venous or arterial thrombosis in combination with the presence of lupus anticoagulant (LAC) oF antibodies to cardiolipin (anti-cardiolipin antibody [ACA], immunoglobulin G [IgG] and immunoglobulin M [IgM]).! In order to establish the diagnosis of APAS, itis advisable to carry out the first blood sampling at least 12 weeks after the latest miscarriage and to confirm the laboratory abnormalities after at least 12 weeks.! Lifestyle: Patients with RPL should be advised on lifestyle modification, (Level Ill, Grade B) ‘Supporting Statements Advice relating on lifestyle should include: weight loss (in cases of an increased body mass index (BMI, smoking cessation, healthy food. Vitamin intake is not relevant? Unexplained recurrent miscarriages: In atleast half ofthe couples with Tecurrent miscarriage, diagnostic investigations do not provide an underlying cause and the final diagnosis is unexplained miscarriage or recurrent miscarriage. (Level III, Grade C) Supporting Statements For this group of patients, no effective treatments have been discovered through randomized trials. The only therapeutic measure that is left is ‘tender lovingecare” care, whereby a successful outcome ofthe pregnancy is described in 85%. It is recommended only to carry out new treatments in this group of patients in a randomized trial context, Research also provides insight into the success rates based on the maternal age and the number of previous miscarriages. It is advisable to discuss this table with the patient and to estimate her individual chances of suecess in a subsequent pregnancy. The contemporary translation of tender loving care in the support of women with unexplained recurrent miscarriage might consist of the following advice: Stop smoking, extra attention by an early ultrasound, 21and preconceptional intake of folic acid. Psychosocial support is very important and referring the couple to an Early Pregnancy Unit (EPU) for preconceptional diagnostic investigations and advice as well as participation in current studies is also recommended? Minimum Care Required The following is based on the recommendations of the Dutch Society of Obstetrics and Gynaecology (NVOG) regarding recurrent miscarriage ‘Table 2: Recommendations for Treatment in Couples with Recurrent Miscarriage De Dont Evidence Level Pre-implantation genetic screening = Giada (PGs) controled trials (RCTs) Pre-implantation genetic diagnosis (PGD) (indication of structural chromosome abnormality in male ino RGIS or female partner) Progesterone or P-hCG zi B ‘Correction of uterine anomaly x No RCTs ‘Anticoagulant treatment (indication | yyy a antiphospholipid syndrome) x B ‘Advise to lose weight x B ‘Stop smoking x B Eat healthily x c Calculate prognosis for subsequent pregnancy (if unexplained recurrent x B miscarriage) 22References 10, Hs 12, 13, Berek, Jonathan $ (Eds). Berek and Novak's Gynecology, 4th Edition. Lippincott Williams & Wilkins, 2007. ‘The Dutch Society of Obstetrics and Gynaecology (NVOG). Guideline on recurrent miscarriage. The Netherlands 2007,6:20. Cuningham G, et al (Eds). “Abortion” In: Williams Obstetrics. MeGraw-Hill Companies, ine. 2010. Royal College of Obstetricians and Gynaecologists (RCOG). The management of carly Pregnancy loss. Royal College of Obstetricians and Gynaecologists (RCOG) Guideline No. 25. 2006;18. European Society of Human Reproduction and Embryology (ESHRE) Special Interest Group for Early Pregnancy (SIGEP). Updated and revised nomenclature for description of early pregnancy events. Human Reprod 2005;20(11):3008-3011 Gautfberg SV. Early pregnancy loss. Contributor Information and Disclosures. Updated: April 16, 2010. Shields AD. Pregnancy diagnosis. Contributor information and Disclosures. Updated: April 20, 2009, Bottomley C, Van Belle V, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T, ‘The optimal timing of an ultrasound scan to assess the location and viebility of an early pregnancy. Human Reprod 2009;24(8):1811-1817. Stubblefield PG Grimes DA. Septic abortion. New Engl J Med 199. 314. Broklchurst TJ, etal. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled tral (miscarriage treatment (MIST) tral). Br Med J 2006;332:1235-1240, Finkelman JD, De Feo FD, Heller PG, Afessa B. The clinical course of patients with septic abortion admitted to an intensive care unit. mensive Care Med 2006:30(6). Davis VJ. Induced abortion guidelines. SOGC Clinical Practice Guidelines 2006;184, Chan FY, Ghosh A, Tang M, Ng.J. Ultrasound in prenatal diagnosis: use and pitfalls J Hong Kong Med Assoc 1991;43(2), 1(5): 310- 23UNSAFE ABORTION Sybil Lizanne R. Bravo, MD and Lorina Q. Esteban, MD Definition 1. Induced Abortion — medical or surgical termination of pregnancy before the time of fetal viability’ 2, Unsafe Abortion —a procedure carried out by persons lackingthe necessary Skils or in an environment that does not conform to minimal medical standards, or both? ‘WHAT IS AN ABORTION LAW? (Lifted from The Revised Penal Code of the Philippines, (AN ACT REVISING THE PENAL CODE AND OTHER PENAL LAWS) ‘The basic status of abortion in the Philippines is that itis illegal, or banned by rule of law. “The actis criminalized by the Revised Penal Code of the Philippines, which was enacted in 1930 and remains in effect today, Articles 256, 258 and 259 of the ees cmandate imprisonment for the woman who undergoes the abortion, as wel! as for any person who assists in the procedure, even if they be the woman’ paren, 6 physician or midwife. Article 258 further imposes a higher prison fer 4h the woman er her parents if the abortion is undertaken “in order to conceal [the woman's} dishonor”. “There is no law in the Philippines that expressly authorizes abortions in order to save the woman's life; and the general provisions which do penalize abortion weake no qualifications if the woman’s life is endangered. It may be argued that an abortion to save the mother’s life could be classified as a justifying cireumstane® (Gress as opposed to self-defense) that would bar criminal prosecution under the ares tonal Code. However, this has yet to be adjudicated by the Philippine Supreme Court. Proposals to liberalize Phil Catholic Church, and its opposi ippine abortion laws have been opposed by the has considerable influence in the predominantly 24Catholic country. However, the constitutionality of abortion restrictions ha8 yet to be challenged before the Philippine Supreme Court. (see Appendix) Clinical Manifestations 1, Symptoms! a. fever b. chills c. malaise d. abdominal pain ©. vaginal bleeding £. passage of placental tissues 2. Signs'3* a. elevated temperature b. tachycardia c. tachypnea 4. with sepsis: agitation, patients appears toxic/disoriented €. lower abdominal tenderness f. absence of fever with leukemoid reaction (white blood cell [WBC] 45-120,000/mm?) 8. fluid sequestration h. hypotension i. edema of infected tissues 3, Abdominopelvic examination . most often an open cervix with bleeding and foul smelling products of conception or discharge b. cervical/vaginal lacerations ©. open cervix with or without a catheter d. bimanual examination: uterine tenderness (with or without parametrial cellulitis or abscess) with gas gangrene of the uterus: crepitation in the pelvis abdominal tenderness, guarding, and rebound, and whether tenderness is limited to the lower abdomen (pelvic peritonitis) or is present over the entire abdomen (generalized periton mo Supporting Statements Infection after abortion is an ascending process that occurs more commonly in the presence retained products of conception or operative trauma. Uterine perforation may be followed by severe infection, whether or not there is bowel injury? 25Finkielman, et. al. described the clinical course, complications, and outcome of patients with septic abortion admitted to the intensive care unit (ICU). The records of the 63 patients of a university hospital in Argentina between 1985 and 1995 were reviewed. The mean age of the patients was 28.5 years, and 33% had had previous abortions. The mean gestational age was 10,5 weeks. The first ICU day Acute Physiology and Chronic Health Evaluation (APACHE) II mean score was 13.9. Acute renal failure developed in 73% (46 of 63) of the patients, disseminated intravascular coagulation (DIC) in 31% (15 of 49), and septie shock in 32% (20 of 63). Blood cultures were positive in 24% (15 of 62). Twelve patients died (19%), Eight of the deaths occurred during the first 48 hour of the ICU admission. Compared with survivors, non-survivors had higher median number of organ failures (1.0 vs 4.0, p<0.0001), mean first ICU day SOFA scores (6.6 vs 10.0, p=0.0059), and mean APACHE II scores (12.7 vs 20.2, p=0.0003), and were more likely to have septic shock (18 vs 92%, p<0.0001), and receive dopamine (37 vs 83%, p=0.0040), mechanical ventilation (8 vs 83%, p<0.0001), and pulmonary artery catheter (8 vs 41%, p=0.0026). Although itis an avoidable complication, septic abortion requiring admission to the ICU is associated with high morbidity and mortality. Diagnosis A complete blood count is necessary in the diagnosis of induced abortion. (Level II/, Grade A) Supporting Statement Acomplete blood count and differential are necessary baselines in the management of patients with delayed postabortal infection.” 2. Swabbing of the endocervix should be done to detect Chlamydia trachomatis and Neisseria gonorrhea. (Level Ill, Grade C) ‘Supporting Statements The legal termination of pregnancy has introduced its own spectrum of infectious morbidity. The primary contributing factors are those of omission or commission. The principal error of omission is the failure to monitor the patient for occult infection due to Neisseria gonorrhea or Chlamydia trachomatis. Technical errors like failure to completely evacuate the uterus or to ensure adequate hemostasis constitute the errors of commission. Infections due to exogenous virulent pathogens usually occurs within eight hours or less of the procedure. Due to the action of the group A, C or 26G B-hemolytic streptococci, the patients get sick rapidly. Screening for NV. gonorrhea in high risk populations is advisable. Screening for C. trachomatis should be done for all women. If the endocervical culture is positive at the time of curettage, the infection rate for women undergoing operative termination of pregnancy increases three fold. Approximately 15% of women harboring the gonococcus at the endocervix develop postabortal infection."! 3. Submit endometrial tissue specimen forgram stain and culture. (Level II, Grade C) ‘Supporting Statements Gram stain of the endometrium will show mixed flora admixed with white blood cells. If peritoneal signs are present, baseline tissue culture of the endometrium is recommended. Doing sampling of the endometrium and sending it for culture will lead to identification of the bacterium responsible for the infection. This will be helpful in managing complicated infections following abortion. The specimen should be placed in aerobic and anaerobic transport media and sent to the laboratory for processing, '"! 4. Blood culture should be done in all patients who have: (a) advanced disease, (b) peritoneal signs, and (3) rigor." (Level III, Grade A) 5. Transvaginal ultrasound (TVS) can detect retained secundines or fluid within the endometrial cavity and myometrial disruption. It can detect the presence of a pelvic mass and should be obtained if pelvic tenderness or examination prohibits the performance of adequate examination. (Level Il, Grade A) Supporting Statement The presence of foul smelling discharge after legal termination of pregnancy is suggestive of retained products of conception, which can be confirmed by TVS."""!2 Chest x-ray / Computed tomography (CT) scan / Magnetic resonance imaging (MRI): These tests are valuable in assessing the entire abdomen and pelvis for presence of abscesses and in detecting suspected gangrene. (Level III, Grade C) 27‘Supporting Statements If peritoneal signs are present or the patient’s condition worsens, a roentgenogram of the pelvis or a CT scan is indicated. The presence of a gas pattern in the uterine wall or the pelvis or a localized ileus are indications for surgical intervention. ‘ACT scan is useful in assessing the entire abdomen and pelvis for the presence of abscesses. It may also be used for percutaneous drainage under direct visualization." 7. Protime / prothrombin time, serum electrolytes, aspartate transaminase (AST) /alanine transaminase (ALT), blood urea nitrogen (BUN), creatinine: Liver and kidney function tests should be monitored especially if there is evidence of systemic deterioration. (Level HI, Grade A) ‘Supporting Statement Because many antibiotics are excreted by the kidneys and nephrotoxic, early evaluation of the renal function is important. If there is impaired kidney function, the dosages of the antibiotics will be adjusted.’ Management 1. Periabortal use of antibiotics in therapeutic abortion has protective effect. (Level I, Grade A) ‘Supporting Statements Ina meta-analysis of 12 studies done, there is a substantial protective effect of antibiotics in all women undergoing therapeutic abortion even though in low risk groups. Sawaya, et. al. reported on overall summary relative risk (RR) for developing postabortal upper genital tract infection in women receiving prophylactic antibiotic of 0.58 (95% confidence interval [Cl] 0.47-0.72) ‘compared with women receiving placebo. In high risk women (with history of pelvic inflammatory disease [PID], there was a summary RR of 0.56 (95% C10.37-0.84). In women with no risk factors, the RR was protective at 0.65 (95% Cl 0.47-0.90). In summary, the routine use of periabortal antibiotics in the United States may prevent up to half of all cases of postabortal infections.”? 282. Several antibiotic regimens that have been found to be effective are recommended. (Level III, GPP) Supporting Statement Most patients with postabortion infection due to retained products of conception respond to combined medical/surgical therapy. A number of successful parenteral antibiotics have been used. (See algorithm) 3+ The antibiotic regimen should be continued until the following Sought for therapeutic response is attained: a. No temperature equal to or greater than 37.6°C b. Absence of local physical findings © Anormal white blood cell count (Level Ill, Grade A) ‘Supporting Statements ampicillin $00 mg every 6 hours for four to five days has been uscd {2 potential medico-legal rather than serious therapeutie indications. Once the previously defined therapeutic end titration points are achieved, no further antibiotic therapy is. necessary." Unsafe abortions result not only in costs for acute care but may also be responsible for longer-term complications such as PID, damage (0 reproductive organs, and secondary infertility. If effective, antibione Prophylaxis atthe time of the procedure can potentially prevent thecs adverse consequences. Incomplete abortions cause many complications and the deaths of tens of thousands of women each year. Women who seek health ene after an incomplete abortion usually come for problems fron bleeding {00 much or infection, Antibiotics are generally given when there me fians of infection. The review of trials showed difficulties for wome, in continuing to take antibiotics and returning for care, so 4. Atransfusion threshold of hemoglobin of 7-9, g/dl is reasonable."* (Level Il, Grade C) 295. Curettage is recommended if retained secundines are seen on TVS. ‘The procedure should be done within 4-8 hours after admission. (Level I, Grade A) ‘Supporting Statement ‘There were no reports of maternal deaths in the trials identified. Vacuum aspiration versus dilatation and curettage: There were no statistically significant differences for excessive blood loss, blood transfusion, febrile morbidity, incomplete or repeat uterine evacuation procedure, re-hospitalization, postoperative abdominal pain or therapeutic antibiotic use. Duration of operation was statistically significantly shorter with vacuum aspiration compared to dilatation and curettage in both gestational age subgroups: <9 weeks: weighted mean difference (WMD) “1.84 minutes, 95% Cl -2.542 to -1.138); =/> 9 weeks: WMD -0.600 minutes, 95% CI -1.166 to -0.034, Flexible versus rigid vacuum aspiration cannula: There were no statistically significant differences with regard to cervical injuries, febrile morbidity, blood transfusion, therapeutic antibiotic use, or incomplete or repeat uterine evacuation procedure. “Manual vacuum aspiration (MVA) versus electrical vacuum aspiration: Severe pain was reported less often with MVA compared to electrical ‘vacuum aspiration in women with <9 weeks of amenorrhea (RR 0.73, 95% C1 0.47- 1.16).In women with amenorrhea > 9 weeks, severe difficulty of the procedure was reported more frequently with MVA compared to electrical vacuum aspiration (RR 5.7, 95% CI 2.45-13.28). There was no difference in cervical injuries, excessive blood loss, blood transfusion, febrile morbidity, repeat uterine evacuation, duration of operation and women’s preference between the two groups. Authors? conclusions Complications for surgical first trimester abortion are rare. The included studies do not indicate overall benefits of one over the other method, MVA can be used for early first trimester surgical abortion, but may be more difficult when used later in the first trimester. Duration of procedure is shorter with vacuum aspiration compared to dilatation and curettage, which may be of importance when using local anesthetics or for busy clinies. Outeomes such as women’s satisfaction, the need for pain relief or surgeon’s preference for the instrument have been inadequately addressed. No long-term outcomes, such as fertility after surgical abortion, are available. 309. Vacuum aspiration is a safe and quick treatment for incomplete abortions. (Level J, Grade A) Supporting Statements Two trials were evaluated. Vacuum aspiration was associated with statistically significantly decreased blood loss (-17 ml WMD, 95% CI-24 to -10 ml), less pain (RR 0.74, 95% C1 0.61-0. 90), and shorter duration of procedure (-1.2 min WMD, 95% CI-L.5 to-0.87 min), than sharp curettage, in the single study that evaluated these outcomes. Serious complications such as uterine perforation and other morbidity were rare and the sample sizes of the trials were not large enough to evaluate small or moderate differences.” Authors’ conclusions Vacuum aspiration is safe, quick to perform, and less painful than sharp curettage, and should be recommended for use in the management of incomplete abortion. Analgesia and sedation should be provided as necessary for the procedure. The following are considered indications for exploratory laparotomy:"* a. (+) peritoneal signs and demonstration of gas pattern by x- ray or CT sean b. persistent fever > 36 hours after triple therapy and evacuation (Level Ill, Grade B) Uterine perforation should be treated empirically with antibiotics when this diagnosis is being considered and prompt gynecologic consultation should be obtained. Diagnosis and definitive management are accomplished with laparoscopy and exploratory laparotomy when indicated.” (Level III, Grade B) Properly timed surgery for evacuation of septic products and/or pus and for repairing damaged bowels is important (Level Ill, Grade B) 31Algorithm for Management of Induced Abortion (Adopted and modifi Diseases)" fied from POGS Clinical Practice Guidelines on Infectious Aatbiotes Penicin G4 M units V 96 Gentamicin 23ghg qb Renate: Cindamycin 900 mg NV 8. + aminoglycoside Impenem 500 mgIVg6, Ertapenem t gramtVO0 Prperacdin Tazobactam 3375mg Nv @6 jafter thorough history taking and physical examination ‘severity/grading of abortion (see table below) ‘empiric antimicrobial therapy before shifting to culture-guided treatment alternative choice includes clindamycin for pentcillinallergle patients, and other higher ‘generation beta-lactam antibiotics ‘may give anti-tetanus vaccine if insult is within 24 hes 32Manage accordingly “consider exploratory laparotomy if without/poor response to initial antimicrobial therapy or if high index of suspicion for retained products of conception (or when TVS shows retained products), or if cannot rule out organ injury 33Determining the severity of the condition is critically important in appropriately prioritizing therapeutic intervention. A scoring mechanism for classification of the severity of infected abortion modified from Hager (1985) is recommended in the table below:” coil ea cll Low abdominal pain Cervical motion tendemess Purulent or foul discharge Scanty profuse adnexal mass* ‘Absent zal present R adnexal mass* ‘Absent present L adnexal tenderness Radnexaltendemess | ‘Temperature 38-39°C 39-40°C > 40°C [Trimester = 1 weeks > 12 weeks History of instrumentation Suspicion Confirmed ‘TOTAL SCORE Interpretation TOTAL SCORE Mild 8 Moderate 812 Severe >20 Notes: + The infection is considered “Severe” if any one of the following conditions are present REGARDLESS OF THE SCORE: 1. Hypotension with tachycardia unless secondary to blood loss 2. Tachypnea (respiratory rate >24) + Initial response of hypotension and tachycardia to hydration may signify hypovolemia. * Presence of bilateral adnexal masses is considered “Severe”. 34References 1 I. 18, 19, Jncrican College of Obstetricians and Gynecologists. Induced Abortion, November 2008, Ledger WJ. Infectious complications associated with legal termination of pregnancy. Boog ORG DA Baker. infections Diseases in Obsterics and Gynecologye 6 ha Rostabortion complication, bacteremia sepsis, and septic shock. In: Sweet RL, Gibbs BS. infectious Complications of the Female Genital Tract, 3® Ed, 2009, richtenberg ES, Grimes DA, Paul M. Abortal complications: prevention and Nentgement. In: PaulM, etal. Clinician’ Guide to Medical and Surgical Abortion, New York: Churchill Livingstone, 1999, Masinde, Gumodoka B. Management of postabortion compli Gynecol Obstet 2010;12(2), Finkielman JD, De Feo FD, Heller PG, Afessa B. intensive Care Med 2004 Jun;30(6):1097-102, gains CK. Humphries R. Current Diagnasts and Treatment Emergency Medicine, 6" Ed. East Norwalk, CT: McGraw Hill, 2008, Tak Spontaneous and recurent abortion: etiology, diagnosis, reatment. In: Katz YL. Lentz GM, Lobo RA, Gershenson DM (Eds). Comprehensive Gynecology. 5* Ed. Philadelphia, Pa: Mosby Elsevier, 2007. (ea ol Jauniaux ERM, Pregnancy los. In: Gabbe SG, Niebyl JR, Simpson IL (iis), Cbsteris: Normal and Problem Pregnancies. 5 Ed. Philadelphia, Pa, Poet Churchill Livingstone, 2007. Laurino MY, Bennett RL, Saraiya DS, et al. Genetic evaluation an couples with recurrent miscarriage: Recommen; Genetic Counselors. J Genet Couns 2005;14(3), Gilles RG. Monif, David A. Baker. Infectious complications associated with legal soon ion of Pregnancy, In: nections diseases in obsteries and gynecology, 68d 2008. cebastian Fand Soper DF, Infectious diseases in women, Philadelphia: W. B. Saunders Company, 2001, Siutay® GF, Grady D, Kerliwoske K, Grimes DA. Antibiotics atthe time of induced abortion the case for universal prophylaxis based on a meta-analysis. Obey ‘Gynecol 1996;87:884. Wi8Y W, Glmezoglu AM, Ba-ThikeK. Antibiotics for incomplete abortion. Cochrane Database Syst Rev 2007, Issue 4. Art. No.: CDO01779, DOI lo mane 14651858.CD001779.pub2. Guinn DA, Abel DE, Tomlinson MW, Early goal-trected therapy for sepsis during Pregnaney. Obstet Gynecol Clin N Am 2007:34:459-79, The Internet J * Kalier R Cheng L, Fekin A, Hofmeyr GJ, Campana A. Surgical methods for frst imester termination of pregnancy. Cochrane Database of Systematic Revi 204 1, Issue 4. Art. No.: CD002900. DOI: 10.1002/14651858.CD002900, LaNad A, etal. Septic induced abortions. J Ayub Med Coll Abbotabad 2008; 20(4) pine McCullough. Complications of induced abortion. In: Harwood: Nuss" lino Practice of Emergency 4*ed. Lippincott Williams & Wilkins 2005. 35APPENDIX LEVELS OF EVIDENCE AND GRADES OF RECOMMENDATION LEVEL DEFINITION I Evidence obtained from at least one properly randomized controlled trial. Mel Evidence obtained from well-designed controlled trials without randomization. 11-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. 13 Evidence obtained from multiple time series with or without the intervention, m1 Opinions of respected authorities, based on clinical experiences descriptive studies and case reports or reports of expert committees. GRADE DEFINITION A ‘There is good evidence to support the recommendation of the practice in abortion. B There is fair evidence to support the recommendation of the practice in abortion, c There is insufficient evidence to recommend for or against the inclusion of the practice in abortion. D There is fair evidence to support the recommendation that the practice be excluded in abortion, E There is good evidence to support the recommendation that the practice be excluded in abortion. GPP A good practice point (GPP) is a recommend: based on the experience of the Task Force, 39