Antepartum and intrapartum risk factors of birth asphyxia

in neonates– A Prospective study

A Dissertation protocol to Scientific Committee: Institutional Ethics

Committee, Kasturba Medical College, Mangalore in Fulfillment for the
Award of

Post Graduate Degree in Obstetrics and Gynecology

By S.Poojitha

Principal Investigator (S.Poojitha)

Registration No:157063

Official Address:Department of Obstetrics and Gynaecology,Kasturba Medical College,

Mangalore-575001

Email Id:poojithasathish10@gmail.com

Under the guidance of: Dr. Barathi Rao, Professor, Obstetrics and Gynecology, Kasturba
Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka.
India- 576104

Date of Submission:

1. Introduction Perinatal asphyxia happens in 2 to 10 per 1000 newborns that

are born at term, and more for those that are born prematurely.[1,2]World
Health Organization (WHO) estimates that 4 million neonatal deaths occur
 yearly due to birth asphyxia, representing 38% of deaths of children under 5
years of age.

Fatalities from perinatal asphyxia remain high in developing countries, and

continually assessing its risk factors will help improve outcomes in these
settings.[3,4]

The United Nations Sustainable Development Goals [5] have adopted 17

Global Objectives for the betterment of everyone everywhere on a variety of
global pressing issues and challenges. This study on antepartum and
intrapartum risk factors of birth asphyxia in neonates would align with UN
SDG’s 2030 Agenda 3 - Ensure Healthy Lives and Promote Well Being for
All at All Ages.Under this Agenda, various health and well being related
discussions have been emphasized, amongst which Agendas 3.2 - By 2030,
end preventable deaths of newborns and children under 5 years of age, with
all countries aiming to reduce neonatal mortality to at least as low as 12 per
1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live
births, and, AgendaS 3.d - Strengthen the capacity of all countries, in
particular developing countries, for early warning, risk reduction and
management of national and global health risks, shall be taken into account
during this study.

2. Knowledge gap identified: This study will will bridge the gap of a lack of

data about risk factors for birth asphyxia in this study setting

3. Review of Literature:

Risk factors of birth asphyxia in neonates

In 2018, Dr.Mohammed Abdul and Dr.Sabia Tarannum conducted an
observational prospective study[6] of 100 babies delivered in Gandhi
Medical College in Telengana, requiring resuscitation, and concluded that the
most common maternal risk factors for newborns requiring resuscitation was
 PIH followed by oligohydramnios, multiple gestation, PROM, Diabetes
mellitus and UTI. IUGR was the most common fetal risk factor followed by
fetal distress, prematurity, MAS and mal-presentations.
Determinants of birth asphyxia among newborns in referral hospitals of
Amhara National Regional State, Ethiopia.
In 2019, Maesha AD, Azage M,Woku E, conduted a facility based
case control study[7] of 193 neonates in referral hospitals of Amhara State,
Ethiopia with APGAR score <7 at fifth minute of birth , concluded that Low
birth weight, babies delivered at health centres, instrumental delivery and
prolonged labour were the significant determinants of birth asphyxia.

Risk Factors Associated With Birth Asphyxia in Term Newborns at a

Tertiary Care Hospital of Multan, Pakistan

In 2020, Ghazanfar Nadeem, Abdul Rehman and Humaira Bashir conducted

a case control study[8] of 426 newborns with APGAR score less than 5 at
first minute at a Tertiary Care Hospital of Multan, Pakistan and concluded
that Meconium stained liquor is a major risk factor for birth asphyxia.
Prolonged labor of more than 24-hour period, as well as fetal distress, is also
a major risk factor of perinatal asphyxia.

4. Aims: •To analyse the risk factors of birth asphyxia in neonates delivered in

Lady Goschen hospital, Mangalore and KMCH Attavar, Mangalore.

5. Objectives:
To determine the contributory antepartum and intrapartum risk factor in a
neonate with birth asphyxia.
 To study the outcome of such asphyxiated neonates.

6. Methodology: (should be written in future tense). Describe how the

objectives will be achieved under the following headings:

a. Study setting: Government Lady Goschen hospital, Mangalore and

KMCH Attavar, Mangalore.
b. Study design: Prospective observational study.
c. Study participants:Neonates delivered in LGH and KMCH Attavar
d. Inclusion criteria: All newborns, delivered both vaginally and by
cesarean section ,in LGH and KMCH Attavar, with gestational age ≥28
 weeks or birth weight ≥1000 grams ,cord blood ph less than 7.2[9] Apgar
score less than 3 at 5 minutes during the study period.
e. Exclusion criteria:
Neonates were excluded if they are suffering from major congenital
anomalies or syndromes, e.g. anencephaly, cleft palate with cleft lip,
encephalocele, omphalocele, gastroschisis, and spina bifida.Neonates
requiring just the initial steps of resuscitation were excluded.Mothers
who undergo surgery under general anaesthesia.Incomplete
documentation (no maternal or fetal measurement parameters).
f. Study duration:---
g. Sample size: 100
h. Sampling method: convenient sampling
i. Tool for data collection: Profoma
j. Data collection methodology: (Briefly explain the flow of the study in
detail and in clear terms).
k. Test procedure : Neonatal cord blood sampling at birth
l. Outcome variables: Percentage of contribution of various risk factors to
birth asphyxia in neonates in this study setting
m. Biological materials required :Blood(neonatal cord blood for ph)
n. Data analysis:
Data will be entered in microsoft excel sheet,Statistical package- SPSS
ver.25 will be used to do the analysis.For observational data :results will
be indicated in percentage.The data obtained will be analysed and
concluded upon maternal and fetal outcome.

7. Ethical considerations:
8. References:
[1]Etuk SJ, Etuk IS, Ekott MI, Udoma EJ. Perinatal outcome in pregnancies
booked for ante-natal care but delivered outside health facilities in Calabar,
Nigeria. Acta Trop. 2000;75:29-33.
[2]Akhter S, Momen MA, Rahman MM, Parveen T, Karim RK. Effect of
maternal anemia on fetal outcome. Mymensingh Med J. 2010;19(3):391-8.
[3] UNICEF. The State of The World’s Children. 2008. Available at:
http://www.unicef.org/sowc08/docs/sowc08.pdf. Accessed on 22 April 2019.
[4]. Bang AT, Bang RA, Baitule SB, Reddy HM, Deshmukh MD.
Management of birth asphyxia in home deliveries in rural Gadchiroli: the
effect of two types of birth attendants and of resuscitating with
mouth-to-mouth, tube-mask or bag-mask. J Perinatol. 2005;25(1):82-91.
[5]. United Nations, The 2030 Agenda and the Sustainable Development
Goals: An opportunity for Latin America and the Caribbean (LC/G.
2681-P/Rev. 3), Santiago, 2018.
[6]. Saleem M A, Tarannum S. Risk factors of birth asphyxia in neonates.
Pediatric Rev: int j pediatrics res [Internet]. 2018Dec.31 [cited
2023Jun.18];5(12):603-8. Available from:
https://pediatrics.medresearch.in/index.php/ijpr/article/view/448
[7].Meshesha AD, Azage M, Worku E, Bogale GG. Determinants of Birth
Asphyxia Among Newborns in Referral Hospitals of Amhara National
Regional State, Ethiopia. Pediatric Health Med Ther. 2020;11:1-12
https://doi.org/10.2147/PHMT.S229227
[8]Nadeem G, Rehman A, Bashir H. Risk Factors Associated With Birth
Asphyxia in Term Newborns at a Tertiary Care Hospital of Multan, Pakistan.
Cureus. 2021 Oct 13;13(10):e18759. doi: 10.7759/cureus.18759. PMID:
34796056; PMCID: PMC8590025.
[9]Sendeku FW, Azeze GG, Fenta SL. Perinatal asphyxia and its associated
factors in Ethiopia: a systematic review and meta-analysis. BMC Pediatr.
2020 Mar 24;20(1):135. doi: 10.1186/s12887-020-02039-3. PMID:
32209083; PMCID: PMC7092562.
9. Proforma:

Name of the mother :

Age :
Address :
Married life :
Obstetric history :
Date of delivery :
Hospital number :

Gestational age at delivery:

Term (37-42 weeks) :
Preterm (<37 weeks) :
Post term (>42 weeks):
Antepartum risk factors:
Related to current pregnancy:
1. Pregnancy Induced Hypertention and spectrum:
2. Gestational Diabetes Melitus:
3. Anemia:
4. Thyroid disorders:
Chronic:
1. Diabetes melitus:
2. Hypertension:
3. Anemia:
4. Epilepsy:
5. TB/Asthma/Respiratory disorders:
6. Autoimmune disorders:
7. Others:
Type of onset:
Spontaneous:
Induced:
If so, method of induction:
If so, reason for induction:
1. IUGR
2. Doppler changes
3. RLFW
( Risk of loss of fetal wellbeing)
 (Pathological or non-reactive
CTG with biophysical profile
<8/10, or a persistently
non-reactive CTG at 12–24 h
despite >/= 8/10 )
4. Postdated pregnancy
(>40 weeks)
5. PROM
6. Maternal disease
unrelated to pregnancy
7. Maternal disease related
to pregnancy
(eg. preeclampsia)
Type of delivery:
Vaginal:
Eutocic:
Instrumental:
Cesarean section:
Elective:
Emergency:
Type of amniorexis:
Spontaneous rupture
Artificial rupture of membranes
Type of monitoring of FHR:
Continuous:
Intermittent:
Sex of neonate:
Male:
Female:
Other:
Analgesia used antenatally:
Epidural:
Spinal:
General:
Neonatal weight:
> 4 Kg :
2.5 Kg :
< 2.5Kg:
 Duration of first stage:
Duration of second stage:
10. Budget estimation: Self-sponsored
11. Annexure of tool for data collection:

12. Annexure of participant information sheet:

Title of study: Antepartum and intrapartum Risk factors of birth asphyxia in

neonates– A Prospective study
The information obtained will be used only for the purpose of study.
Confidentiality will be maintained.
The course of the study shall not affect management of the patient in
anyway.
This study does not use any interventional procedures or drugs that are not
standard practice in the hospital.
If you wish to enquire further regarding the safety or details of enrolling in
this study, you can contact
the principal investigator, or an unbiased medical professional suggested by
us.

Name of the investigator: Dr. Poojitha.S(6384400810)

Postgraduate in Department of Obstetrics and Gynaecology
Kasturba Medical College, Mangalore

Dr. SHALINI SHENOY MULKI DR. VARADRAJ SHENOY

Member Secretary,
KMC Institutional Ethics Committee,
Light house hill road,Mangalore,575001
Phone:9845497072
Mail: shalini.shenoy@manipal.edu.

DR. VARADRAJ SHENOY

Chairperson at Institutional Ethics committee,
Professor of Pediatrics,
Father Muller Medical College,
Mangalore,575002
 Mail : vskudpi@rediffmail.com

13. Informed Consent Form:

Name of the participant :

Documentation of the informed consent :

I have read the information in this form (or it has been read to me). I was
free to ask any questions and they have been answered. I hereby give my
consent to be included as a
participant in the study Antepartum and intrapartum Risk factors of birth
asphyxia in neonates– A Prospective study
The nature and purpose of data is for research work. The procedure has
been explained to me in detail in the language understandable to me by the
investigator. It has been made clear
to me that all personal details like name, place, religion, past history etc
will be kept strictly confidential. I permit the result obtained to be also used
for academic purpose.

Mangalore SIGNATURE:
Date:
Investigator Certificate :
I certify that all the elements including the nature, purpose and possible
risks of the above study as described in this consent document have been
fully explained to the subject.

Signature of the INVESTIGATOR

Name of the Investigator:
DR. S POOJITHA
Date:
ಒ ಪತ
ಗವ ವವರ ಸ :
ಒ ಪತ ದ :
ಈ ಪತ ದ ನ ಯ ಓ ೕ (ಅಥ ಅದ ನನ
ಓದ ). ೕ ಪ ಗಳ ೕಳ ಕ ಮ
ಉತ ಸ . ಈ ಲಕ Antepartum and
intrapartum Risk factors of birth asphyxia in neonates– A Prospective study ತವ
ಲ ಪನ ಡಲ ಅಧ ಯನದ ಗವ ಸ ನನ ಒ ಯ
ೕ ೕ .
ೕ ದಸ ಪಮ ಉ ೕಶ ಸಂ ೕಧ ಯ ಗ ತ.
ಯ ನ ತ ಂದ ನನ ಅಥ ವ ಯ
ವರ ವ ಸ . ಸ , ಸ ಳ, ಧಮ , ಂ ನ ಇ ಸ ಂ ದ
ಎ ೖಯ ಕ ವರಗಳ ಕ ಪ ಡ ಎಂ ನನ
ಸಷ ಪ ಸ .ಪ ದಫ ಂಶವ ೖ ಕ ಉ ೕಶ ಬಳಸ
ಅ ಮ ೕ ೕ .

ಸ :
ಸ ಳ: ಮಂಗ
ಂಕ:
ತ ಯಪ ಣಪತ :
ಈಒ ಯ ಖ ಯ ವ ದಂ ೕ ನ ಅಧ ಯನದ ಸ ಪ, ಉ ೕಶ
ಮ ಸಂಭವ ೕಯ ಅ ಯಗ ೕ ದಂ ಎ ಅಂಶಗಳ
ಗವ ವವ ಸಂ ಣ ಗ

ವ ಸ ಎಂ ಪ ೕಕ ೕ .

ತ ಯಸ
ಂಕ:
ತ ಯ ಸ :
അനുമതി പ തം
പെ ടു ു യാളുെട േപര്
വിവരമറി ു സ ത ിന്െറ േഡാക ുെമന്േറഷൻ :
ഈ േഫാമിെല വിവര ൾ ഞാൻ വായി ി ു ് (അെ ിൽ ഇത്
എനി ് വായി ി ു )് . എനി ് എെ ിലും േചാദ ൾ
േചാദി ാൻ സ ാത മു ായിരു ു, അവയ് ്ഉ രം ലഭി ു.
ഈ പഠന ിൽ
Antepartum and intrapartum Risk factors of birth asphyxia in neonates– A Prospective
study
പ ാളിയാകാൻ ഞാൻ എന്െറ േകാെസൻറ് നൽകു ു.ഡാ യുെട
സ ഭാവവും ല വും ഗേവഷണ പവർ ന ൾ ാണ്.
ഇൻവിജിേല ർ എനി ് മന ിലാ ാവു ഭാഷയിൽ
നടപടി കമം വിശദമായി
വിശദീകരി ു. േപര്, ലം, മതം, മുൻകാല ചരി തം മുതലായ
എ ാവ ിഗത വിവര ളും രഹസ മായി രഹസ മായി
സൂ ി ുെമ ് എനി ്വ മാ ിയി ു .് ലഭി ഫലം
അ ാദമിക് ആവശ ൾ ും
ഉപേയാഗി ാൻ ഞാൻ അനുവദി ു ു.
മംഗലാപുരം
തീയതി:
കെ ാ ്
ഇൻവിജിേല ർ സർ ിഫി ്:
ഈ സ ത പമാണ ിൽ വിവരി ിരി ു തുേപാെല
പഠന ിന്െറ സ ഭാവം, ഉേ ശ ം, സാധ മായ
അപകടസാധ ത എ ിവ ഉൾെ െടയു എ ാ ഘടക ളും ഈ
വിഷയെ ുറി ് പൂർ മായി വിശദീകരി ി ുെ ് ഞാൻ
സാ െ ടു ു ു.

ഇൻവിജിേല റിന്െറ
ഒ ്
തീയതി
 Form for submission of protocol to Ins tu onal Ethics Commi ee, KMC, Mangalore

I INVESTIGATOR INFORMATION
1. Name of the investigator
(in block letters)
2. Official Address

3. Mobile Number
4. Email Id
II PROTOCOL INFORMATION
1. Title of the research project

2. Name of the Guide

(only for UG and PG students)
3. Name of the coguide/
co-investigator
4. Nature of Submission
A. Undergraduate ICMR /others

B. Postgraduate / PhD Thesis / paper /poster/ case reports/others

C. Staff Sponsored trial/ original study/ poster / case

reports
III PROTOCOL CHECKLIST (Tick the relevant boxes)
A. Title G. Implica ons of the study

B. Introduction And Need For Study H. References in Vancouver style

C. Review of Literature I. Proforma

D. Aims And Objectives J. Informed Consent Form

(In English And Kannada )
E. Materials And Methods – study K. Pa ent Informa on Sheet
design, sample size, methodology
( In English And Kannada )

F. Sta s cal Analysis L. Budget For The Project

(Fill Up The Budget Es ma on Form)
SIGNATURE OF THE INVESTIGATOR SIGNATURE OF GUIDE

SIGNATURE OF CO INVESTIGATOR/CO GUIDE

SIGNATURE OF THE HOD WITH SEAL

PTO
ESTIMATED BUDGET FOR THE PROJECT
NOTE:
1. This application should contain the total cost of routine and special tests done for the
project
2. This form should be submitted along with the application form.

Amount in Rupees YEAR 1 YEAR 2 YEAR 3 TOTAL

Par culars
Sta onery, photocopying,
Binding
Consumables

Equipment’s

Inves ga ons
Rou ne

Tests done for project

(special tests-in house)
Tests sent outside (special
tests outsourced)
Any other medical
devices/medica ons
addi onally used
Grand Total

Sl no Name of the inves ga on No of tests Total amount

Source of Funding for the Research:

Declare Self-funding: Rs.--------------------------
I declare that the study subjects will not be made to pay for the special
investigations/devices/medications. The cost will be born by me or procured from research
grants of ---------------------------------------------------------.
Name and Signature of Principal Investigator.
Name and Signature of Co investigators:
Name of signature of Guide (for PhD/ PG/UG research)
Date :
Note: Submit one hard copy of the protocol (MS Word doc in Times New Roman font 12)
to, Medical Education Unit, KMC and a soft copy as email attachment to
iec.kmcmlr@manipal.edu