ACOG

PRACTICE
BULLETIN
CLINICAL MANAGEMENT GUIDELINES FOR
OBSTETRICIANGYNECOLOGISTS
NUMBER 31, OCTOBER 2001
(Replaces Technical Bulletin Number 206, June 1995; Committee
Opinion Number 172, May 1996; Committee Opinion Number 187,
September 1997; Committee Opinion Number 198, February 1998;
and Committee Opinion Number 251, January 2001)

This Practice Bulletin was

developed by the ACOG Committee on Practice Bulletins
Obstetrics with the assistance
of Jodi F. Abbott, MD. The
information is designed to aid
practitioners in making decisions about appropriate obstetric and gynecologic care. These
guidelines should not be construed as dictating an exclusive
course of treatment or procedure. Variations in practice may
be warranted based on the
needs of the individual patient,
resources, and limitations
unique to the institution or type
of practice.

VOL. 98, NO. 4, OCTOBER 2001

Assessment of Risk
Factors for Preterm Birth
Preterm birth is the second leading cause of neonatal mortality in the United
States (1) (second only to birth defects), and preterm labor is the cause of most
preterm births (2). Neonatal intensive care has improved the survival rate for
babies at the cusp of viability, but it also has increased the proportion of survivors with disabilities (3). The incidence of multiple births also has increased
along with the associated risk of preterm delivery (4). Interventions to delay
preterm delivery in these settings have not shown conclusive effectiveness.
Because the morbidity of babies born after 3435 weeks of gestation has diminished, most efforts to identify preterm deliveries have focused on deliveries
before this age. This document describes the various methods proposed for predicting preterm birth and the evidence for their roles in clinical practice.

Background
Preterm labor is defined as regular contractions associated with cervical change
before the completion of 37 weeks of gestation. Spontaneous preterm birth
includes preterm labor, preterm spontaneous rupture of membranes, and cervical incompetence; it does not include indicated preterm delivery for maternal or
fetal conditions (5). Preterm delivery accounted for 11.8% of births in the
United States in 1999; this figure has increased steadily from 9.4% in 1981 (6).
The pathophysiologic events that trigger preterm parturition are largely
unknown but may include decidual hemorrhage (abruption), mechanical factors
(uterine overdistention or cervical incompetence), and hormonal changes (perhaps mediated by fetal or maternal stress) (79). In addition, several bacterial
infections have been associated with preterm labor. Commonly identified
organisms are Ureaplasma urealyticum, Mycoplasma hominis, Gardnerella

ACOG Practice Bulletin No. 31 Assessment of Risk Factors for Preterm Birth

709

vaginalis, Peptostreptococcus, and Bacteroides species

(10). Because these bacteria usually are of low virulence,
it is unclear whether they are truly etiologic or are associated with an acute inflammatory response of another
etiology.

logic risk scoring systems (2224) have been unable to

reliably identify women who will give birth preterm.

Value of Predicting Risk

Home Uterine Activity Monitoring

The ability to predict whether a woman is at risk of

preterm delivery has value only if an intervention is
available that is likely to improve the outcome. The
opportunity to administer maternal corticosteroid therapy is an important intervention recommended by the
National Institutes of Health because it is strongly associated with decreased morbidity and mortality (1113).
In addition, maternal tocolytic therapy may prolong
pregnancy for up to 48 hours in some women, during
which time corticosteroids can be administered (14).
Because tocolytic and steroid therapy may result in untoward maternal and fetal consequences, use of these therapies should be limited to women with true preterm
labor at high risk for spontaneous preterm birth. Finally,
in women being managed at hospitals without appropriate neonatal resources, identifying women at risk allows
for appropriate maternal transport to a tertiary care center. Conversely, identifying those women at low risk for
preterm delivery would avert the use of unnecessary
interventions.

Tocodynamometry has long been used for hospital-based

evaluation of uterine contractions. Home uterine activity
monitoring (HUAM) has been proposed as a method for
predicting preterm birth in high-risk women. It consists
of a combination of telemetric recordings of uterine contractions with the use of a tocodynamometer and daily
telephone calls from a health care practitioner to offer
patient support and advice. Uterine activity beyond an
arbitrary cutoff triggers notification of the patients
health care practitioner. This approach was based on the
observation that some women who subsequently give
birth before term have an increase in uterine activity earlier in pregnancy than women who give birth at term (25)
and that these prodromal uterine contractions otherwise
may not be recognized by the patient.

Risk Factors
Risk factors for preterm birth include demographic characteristics, behavioral factors, and aspects of obstetric
history. Demographic characteristics that carry a high
risk for preterm birth include nonwhite race (African
American relative risk [RR]=3.3), age younger than 17
years or older than 35 years (RR=1.471.95), low
socioeconomic status (RR=1.832.65), and low prepregnancy weight (odds ratio=2.72) (15, 16). Maternal history of preterm birth, particularly in the second trimester,
has a strong statistical association with the risk of
preterm delivery (17); this risk appears to be associated
with prior spontaneous preterm birth with or without
rupture of membranes and increases the relative risk sixfold to eightfold. Risk also increases with vaginal bleeding in more than one trimester (18). Controversy exists
as to whether an excessively physically stressful job can
lead to early delivery; one study has shown an increase
in spontaneous preterm birth associated with long periods of standing (>40 hours per week) (19). Smoking
increases the risk of preterm birth (20) and low birth
weight, and some evidence suggests it increases the risk
for spontaneous abortion (21). Despite the identification
of a number of risk factors, attempts to determine the
risk of preterm delivery based on historic and epidemio-

710

Biologic Markers for Predicting

Preterm Birth

Salivary Estriol
Activation of the fetal hypothalamic pituitaryadrenal
axis precedes some spontaneous preterm births. Adrenal
production of dehydroepiandrosterone results in
increased placental estrogen synthesis. Observational
studies have shown that maternal levels of serum estradiol and salivary estriol increase before the onset of
spontaneous term and preterm labor (26). These findings
prompted the design of a test to predict preterm delivery
by measuring salivary estriol; however, maternal estriol
levels show diurnal variation, peaking at night (27).
Also, estriol levels may be suppressed by betamethasone
administration (28).

Bacterial Vaginosis
Bacterial vaginosis (BV) is a common alteration of the
normal vaginal flora and has been found in 1025% of
patients in general gynecologic and obstetric clinics and
in up to 64% of patients in clinics for sexually transmitted diseases (29). Fifty percent of women with BV are
asymptomatic (30). Bacterial vaginosis also has been
found more frequently in African-American women
(22%) than in white women (8%) (10, 31). The presence
of BV has been associated with preterm delivery independent of other known risk factors (32, 33).

Fetal Fibronectin Screening

Fetal fibronectin (fFN) is a basement membrane protein
produced by the fetal membranes that functions as an

ACOG Practice Bulletin No. 31 Assessment of Risk Factors for Preterm Birth

OBSTETRICS & GYNECOLOGY

Cervical Ultrasonography
Transvaginal cervical ultrasonography has been shown
to be a reliable and reproducible way to assess the length
of the cervix (38). A prospective blinded trial showed an
association between cervical length and preterm delivery
(39). This study established the normal distribution of
cervical length in pregnancy after 22 weeks of gestation.
It also looked at various cervical measurements as criteria for the prediction of preterm delivery.

Clinical Considerations and

Recommendations

The usefulness of HUAM as a screening test depends on

both its ability to detect women at higher risk for preterm
birth as well as the effectiveness of any intervention to
then prevent preterm birth. At least 13 randomized
controlled trials examining the efficacy of HUAM have
published results (4052). The studies vary in design,
criteria for inclusion of patients, and measurements of
endpoints and outcomes. These differences make comparisons difficult. Furthermore, many of these studies
had limitations with their research design, including
sample size (power) or numbers of patients, that preclude reaching conclusions about the usefulness of
HUAM. Results vary, with some trials reporting no difference and some reporting a difference in outcome in
monitored and unmonitored women. The largest study
involved 2,422 women at risk and showed no improvement in outcome (41).
Earlier studies that showed a reduction in the incidence of preterm birth with HUAM have been criticized
for their flawed design (53, 54); some studies have been
identified as having biases and errors sufficient to war-

VOL. 98, NO. 4, OCTOBER 2001

Does salivary estriol determination predict

preterm birth?

There have been two prospective trials evaluating

whether salivary estriol levels can predict preterm delivery (59, 60); they showed that salivary estriol was more
predictive than traditional risk assessment. However, the
results of the second trial showed a relatively poor sensitivity of 71%, specificity of 77%, and a false-positive
rate of 23% (using delivery before 37 weeks of gestation
as the outcome measure) (60). Because the test carries a
high percentage of false-positive results, its use could
add significantly to the cost of prenatal care, particularly
if used in a low-risk population. Although the hormonal
pathway etiology for some cases of preterm birth is
intriguing, trials with salivary estriol testing to predict
preterm birth have failed to establish its usefulness for
anything more than investigational purposes at present.

Does the use of HUAM predict preterm

birth?

rant dismissing the results (55). The U.S. Preventive

Services Task Force performed an independent review
and concluded the device was not effective (56).
Although the U.S. Food and Drug Administration has
approved a HUAM device for women with a prior
preterm birth, there is no demonstrated role for HUAM
in the prevention of preterm birth. Data are insufficient
to support a benefit from HUAM in preventing preterm
birth (13, 57, 58); therefore, this system of care is not
recommended.

adhesion binder of the placenta and membranes to the

decidua (34, 35). It is normally present in cervical secretions until 1620 weeks of gestation. Numerous trials
have shown both an association with the presence of fFN
and preterm birth (5, 34, 36) and a decrease in the risk of
preterm birth when the test result for the presence of this
protein is negative. The basis for the association of fFN
and preterm birth is unclear. It has been hypothesized
that fFN is a marker for the disruption of the chorioamnion and underlying decidua due to inflammation with or
without infection (34). A positive midtrimester fFN test
result has been associated with subsequently diagnosed
maternal and fetal infection (37).

Do screening and treatment for BV affect the

likelihood of preterm birth?

Trials of screening and treatment for BV in pregnant

women to reduce the incidence of preterm delivery have
been conducted in mixed populations with varying
results. Some small studies found screening and treatment of women at risk for preterm birth reduced the risk
of preterm birth (61, 62), but other studies have not confirmed these findings (63, 64).
A recent meta-analysis reviewed five trials involving 1,504 women (65). The analysis included trials of
women without risk factors for preterm birth as well as
studies that screened general obstetric populations.
Treatments used in these trials included amoxicillin,
clindamycin, and metronidazole. Although investigators
found antibiotic therapy effective at eradicating BV, the
difference in the rate of preterm birth between the two
groups was not statistically significant. However, looking at the subgroup of women with a previous preterm
birth, the difference was significant, with an odds ratio of
0.37 (95% confidence interval, 0.230.60). This metaanalysis did not include results from the most recent and
largest double-blind, randomized controlled trial. This

ACOG Practice Bulletin No. 31 Assessment of Risk Factors for Preterm Birth

711

Does screening for fFN predict preterm birth?

712

Does cervical ultrasonography predict

preterm birth?

Numerous studies have confirmed the association of

cervical shortening with preterm delivery, but they have
varied widely in their predictive value (13, 7577). A
review of 35 studies using cervical length (determined
by ultrasonography) to predict preterm delivery found
sensitivities ranging from 68% to 100%, with specificities from 44% to 79% (78).
A prospective trial of more than 2,900 women evaluated by serial transvaginal ultrasonography at 24 weeks
of gestation and again at 28 weeks of gestation showed
the RR of preterm delivery increased as the cervical
length decreased. Specifically, at 28 weeks of gestation,
when cervical lengths were 40 mm or less, RR was 2.80;
at 35 mm or less, RR was 3.52; at 30 mm or less, RR was
5.39; at 26 mm or less, RR was 9.57; at 22 mm or less,
RR was 13.88; and at 13 mm or less, RR was 24.94 (39).
Despite the usefulness of cervical length determination by ultrasonography as a predictor of preterm labor,
routine use is not recommended because of the lack of
proven treatments affecting outcome (79). Until effective
treatment options are identified, cervical length measurement has limited clinical application.

A meta-analysis of 27 studies showed consistent moderate success using fFN screening to predict preterm birth
(68). Using delivery at less than 34 weeks of gestation as
the outcome, sensitivity was 61% and specificity was
83% (68). A study that analyzed the relationship between
fFN, short cervix, BV, and designated traditional risk factors for spontaneous preterm birth showed the highest
association of preterm birth with positive fFN test result,
followed by a cervical length less than 25 mm and a history of preterm birth (69). The negative predictive value
of the fFN test to identify symptomatic women who are
actually at low risk for imminent preterm delivery ranges
from 69% to 92% before 37 weeks of gestation, with a
greater than 95% likelihood of not delivering within 14
days of a negative test result (13, 70, 71).
Although a negative test result appears to be useful
in ruling out preterm delivery that is imminent (ie, within 2 weeks) (13, 72, 73), the clinical implications of a
positive test result have not been evaluated fully because
no obstetric intervention has been shown to decrease the
risk of preterm delivery. The test should not be routinely
used to screen low-risk, asymptomatic women, because
the incidence of preterm birth in this population is low
and the test, therefore, has limited usefulness (68).
If the test is to be used in specific high-risk groups,
the following criteria should be met: intact amniotic
membranes, minimal cervical dilatation (<3 cm), and
sampling performed no earlier than 24 weeks and 0 days
of gestation and no later than 34 weeks and 6 days of gestation (74). If the test is to be clinically useful, the results
must be available from a laboratory within a time frame
that allows for clinical decision making (ideally within
24 hours).

trial of 1,953 women found no difference in the rates of

preterm birth between the treatment and placebo groups,
and no subgroup demonstrated a statistically significant
difference in preterm birth rates (64).
Although some trials have shown an association with
the presence of BV and preterm birth, most large trials
designed to determine whether treatment of BV can prevent preterm birth have failed. Currently, there are insufficient data to suggest screening and treating women at
either low or high risk will reduce the overall rate of
preterm birth (66). There is speculation that BV could be
either a marker or a cause of choriodecidual inflammation without intraamniotic infection (24). However,
research testing this hypothesis by serial fFN screening in
women with BV was unable to confirm an association
(67).

Should fFN and cervical ultrasonography be

used together to better identify those at highest risk?

In a multicenter trial, investigators found a short cervix

(defined as <25 mm), particularly if associated with a
positive fFN test result, to be a strong predictor of
preterm birth (80). A more recent trial by the National
Institute of Child Health and Human Development
looked at the sequential use of both methods to try to

Table 1. Recurrence Risk of Spontaneous Preterm Birth at

<35 Weeks of Gestation According to Cervical Length and
Fetal Fibronectin in Women with a Prior Preterm Birth
Fetal
Cervical Length (mm) Fibronectin + (%)

Fetal
Fibronectin (%)

25

65

25

2635

45

14

>35

25

Fetal fibronectin and cervical length assessed at 24 weeks of gestation. Cervical length assessed by transvaginal ultrasonography.
Data from: Iams JD, Goldenberg RL, Mercer BM, Moawad A, Thom E, Meis PJ, et
al. The Preterm Prediction Study: recurrence risk of spontaneous preterm birth.
National Institute of Child Health and Human Development Maternal-Fetal
Medicine Units Network. Am J Obstet Gynecol 1998;178:10351040

ACOG Practice Bulletin No. 31 Assessment of Risk Factors for Preterm Birth

OBSTETRICS & GYNECOLOGY

stratify risk groups as well as discern etiologies of

preterm birth (69) (see Table 1). The presence of either a
cervix less than 25 mm in length at less than 35 weeks of
gestation or a positive fFN test result was strongly associated with preterm birth, especially in women with a
history of preterm birth. These data were particularly
useful in decreasing the assessed risk of preterm birth in
women with classic risk factors and negative results of
one or both tests. The success of interventions once a
short cervix is identified or positive fFN test result is
determined remains uncertain (13).

extremely preterm birth. EPICure Study Group. N Engl J

Med 2000;343:378384 (Level II-2)
4. Preterm singleton birthsUnited States, 19891996.
MMWR Morb Mortal Wkly Rep 1999;48:185189
(Level III)
5. Iams JD. Preterm birth. In: Gabbe SG, Niebyl JR,
Simpson JL, eds. Obstetrics: normal and problem pregnancies. 3rd ed. New York: Churchill Livingstone,
1996:743820 (Level III)
6. Ventura SJ, Martin JA, Curtin SC, Menacker F, Hamilton
BE. Births: final data for 1999. Nat Vital Stat Rep
2001;49(1):1100 (Level III)
7. Goldenberg RL, Iams JD, Mercer BM, Meis PJ, Moawad
AH, Copper RL, et al. The preterm prediction study: the
value of new vs. standard risk factors in predicting early
and all spontaneous preterm births. NICHD MFMU
Network. Am J Public Health 1998;88:233238 (Level III)

Summary of
Recommendations
The following recommendation is based on good
and consistent scientific evidence (Level A):

There are no current data to support the use of salivary estriol, HUAM, or BV screening as strategies
to identify or prevent preterm birth.

8. Norwitz ER, Robinson JN, Challis JR. The control of

labor. N Engl J Med 1999;341:660666 (Level III)
9. Lockwood CJ. Stress-associated preterm delivery: the role
of corticotropin-releasing hormone. Am J Obstet Gynecol
1999;180:S264S266 (Level III)
10. Goldenberg RL, Hauth JC, Andrews WW. Intrauterine
infection and preterm delivery. N Engl J Med 2000;
342:15001507 (Level III)

The following recommendations are based on limited or inconsistent scientific evidence (Level B):

11. Effect of corticosteroids for fetal maturation on perinatal

outcomes. NIH Consens Statement 1994;12(2):124
(Level III)

12. Antenatal corticosteroids revisited: repeat courses. NIH

Consens Statement 2000;17(2):110 (Level III)

Screening for risk of preterm labor by means other

than historic risk factors is not beneficial in the general obstetric population.

Ultrasonography to determine cervical length, fFN

testing, or a combination of both may be useful in
determining women at high risk for preterm labor.
However, their clinical usefulness may rest primarily with their negative predictive value given the lack
of proven treatment options to prevent preterm birth.

Fetal fibronectin testing may be useful in women

with symptoms of preterm labor to identify those
with negative values and a reduced risk of preterm
birth, thereby avoiding unnecessary intervention.

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The MEDLINE database, the Cochrane Library, and

ACOGs own internal resources and documents were used
to conduct a literature search to locate relevant articles published between January 1985 and May 2000. The search
was restricted to articles published in the English language.
Priority was given to articles reporting results of original
research, although review articles and commentaries also
were consulted. Abstracts of research presented at symposia and scientific conferences were not considered adequate
for inclusion in this document. Guidelines published by organizations or institutions such as the National Institutes of
Health and the American College of Obstetricians and Gynecologists were reviewed, and additional studies were
located by reviewing bibliographies of identified articles.
When reliable research was not available, expert opinions
from obstetriciangynecologists were used.
Studies were reviewed and evaluated for quality according
to the method outlined by the U.S. Preventive Services Task
Force:
I

Evidence obtained from at least one properly designed randomized controlled trial.
II-1 Evidence obtained from well-designed controlled
trials without randomization.
II-2 Evidence obtained from well-designed cohort or
casecontrol analytic studies, preferably from more
than one center or research group.
II-3 Evidence obtained from multiple time series with or
without the intervention. Dramatic results in uncontrolled experiments could also be regarded as this
type of evidence.
III Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert
committees.
Based on the highest level of evidence found in the data,
recommendations are provided and graded according to the
following categories:
Level ARecommendations are based on good and consistent scientific evidence.
Level BRecommendations are based on limited or inconsistent scientific evidence.
Level CRecommendations are based primarily on consensus and expert opinion.
Copyright October 2001 by the American College of Obstetricians
and Gynecologists. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical, photocopying, recording, or
otherwise, without prior written permission from the publisher.
Requests for authorization to make photocopies should be directed to
Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA
01923, (978) 750-8400.
The American College of Obstetricians and Gynecologists
409 12th Street, SW, PO Box 96920
Washington, DC 20090-6920
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Assessment of risk factors for preterm birth. ACOG Practice Bulletin
No. 31. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2001;98:709716

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