Cervical Ripening in Premature Rupture of Membranes
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 15 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | July 2016 |
| Contact: | Kafui Demasio, MD, MPH |
| Email: | kafui5@netzero.net |
| Phone: | 718-904-2767 |
Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the
vaginal canal before the onset of labor. The integrity of the amniotic membrane is
compromised thereby increasing the risk of intrauterine infection and compression of the
umbilical cord. PROM complicates 3% to 8% of pregnancies in the US and is responsible for
30% of preterm births. Intrauterine infection remains the most significant maternal and
neonatal sequelae associated with PROM and this risk increases with the length of time from
ruptured membrane to delivery. Induction of labor has been shown to reduce the rates of
chorioamnionitis, endometritis and NICU admissions4. Specifically, induction of labor with
prostaglandin agents followed by oxytocin, versus oxytocin alone has been shown to be
effective for labor induction resulting in vaginal delivery. Management strategies for PROM
have been controversial, and published studies on outcomes are over one to two decades old,
which does not account for changes in clinical trends and practice patterns. Recently ACOG
recommends that patients presenting at 37 weeks gestation or greater with PROM should be
induced if not in labor, and "generally with oxytocin". In women with PROM without the onset
of labor, the cervix is commonly unfavorable and induction with oxytocin alone may lead to
an increased risk of cesarean section. With a c-section rate as high as 33%, women
undergoing induction of labor have an increased risk of c-section and its associated
morbidity and long term sequela. ACOG's recommendation for the use of oxytocin as the
induction agent may be meant to avoid a theoretical increased risk of chorioamnionitis in
this patient population however it does not take into account the status of the cervix,
which may result in a increased risk of c-section. The purpose of the proposed study is to
determine whether cervical ripening in women with PROM and an unfavorable cervix is
associated with increase rates of vaginal delivery and decreased cesarean section rate
compared to induction of labor with oxytocin alone. The investigators aim to determine the
incidence of endometritis, and neonatal infection associated with PROM in the current
medical environment of antibiotic prophylaxis and antenatal steroid use, taking into account
the changes in patient characteristics.
vaginal canal before the onset of labor. The integrity of the amniotic membrane is
compromised thereby increasing the risk of intrauterine infection and compression of the
umbilical cord. PROM complicates 3% to 8% of pregnancies in the US and is responsible for
30% of preterm births. Intrauterine infection remains the most significant maternal and
neonatal sequelae associated with PROM and this risk increases with the length of time from
ruptured membrane to delivery. Induction of labor has been shown to reduce the rates of
chorioamnionitis, endometritis and NICU admissions4. Specifically, induction of labor with
prostaglandin agents followed by oxytocin, versus oxytocin alone has been shown to be
effective for labor induction resulting in vaginal delivery. Management strategies for PROM
have been controversial, and published studies on outcomes are over one to two decades old,
which does not account for changes in clinical trends and practice patterns. Recently ACOG
recommends that patients presenting at 37 weeks gestation or greater with PROM should be
induced if not in labor, and "generally with oxytocin". In women with PROM without the onset
of labor, the cervix is commonly unfavorable and induction with oxytocin alone may lead to
an increased risk of cesarean section. With a c-section rate as high as 33%, women
undergoing induction of labor have an increased risk of c-section and its associated
morbidity and long term sequela. ACOG's recommendation for the use of oxytocin as the
induction agent may be meant to avoid a theoretical increased risk of chorioamnionitis in
this patient population however it does not take into account the status of the cervix,
which may result in a increased risk of c-section. The purpose of the proposed study is to
determine whether cervical ripening in women with PROM and an unfavorable cervix is
associated with increase rates of vaginal delivery and decreased cesarean section rate
compared to induction of labor with oxytocin alone. The investigators aim to determine the
incidence of endometritis, and neonatal infection associated with PROM in the current
medical environment of antibiotic prophylaxis and antenatal steroid use, taking into account
the changes in patient characteristics.
We will perform a prospective randomized control trial involving women with singleton
gestation at ≥ 34 weeks gestation who require an induction of labor after diagnosis of PROM
with an unfavorable cervix. PROM will be diagnosed and confirmed with sterile speculum
examination demonstrating pooling and/or positive ferning or nitrazine. Cervical status will
be assessed by visual exam, digital exam or transvaginal ultrasound to assign a Bishop score
(dilation, effacement, station, consistency & position). Determination of patient
eligibility will be based on the clinical exam and confirmation of PROM. Upon diagnosis, if
the patient meets inclusion criteria and accepts to participate in the study, they will be
consented by the study investigator and then be randomized to prostaglandin followed by
oxytocin or oxytocin alone group. Allocation concealment will be performed via the
utilization of pre-sequentially numbered, manila sealed envelopes stapled closed.
There are two treatment groups and will be analyzed on an intent-to-treat basis.
Randomization will be performed using a computer generated simple randomization sequence.
Data safety monitoring will be instituted (see data safety monitoring plan below). Once
randomization is completed, the labor and delivery providers will be informed of the
treatment arm and this will be placed on the chart. Those randomized to the prostaglandin
arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per
hospital protocol. Those randomized to the oxytocin arm will receive infusion of oxytocin,
which will then be titrated per hospital protocol until adequate contractions. Further
management after the start of the respective arm will be based on clinical judgment of the
provider.
gestation at ≥ 34 weeks gestation who require an induction of labor after diagnosis of PROM
with an unfavorable cervix. PROM will be diagnosed and confirmed with sterile speculum
examination demonstrating pooling and/or positive ferning or nitrazine. Cervical status will
be assessed by visual exam, digital exam or transvaginal ultrasound to assign a Bishop score
(dilation, effacement, station, consistency & position). Determination of patient
eligibility will be based on the clinical exam and confirmation of PROM. Upon diagnosis, if
the patient meets inclusion criteria and accepts to participate in the study, they will be
consented by the study investigator and then be randomized to prostaglandin followed by
oxytocin or oxytocin alone group. Allocation concealment will be performed via the
utilization of pre-sequentially numbered, manila sealed envelopes stapled closed.
There are two treatment groups and will be analyzed on an intent-to-treat basis.
Randomization will be performed using a computer generated simple randomization sequence.
Data safety monitoring will be instituted (see data safety monitoring plan below). Once
randomization is completed, the labor and delivery providers will be informed of the
treatment arm and this will be placed on the chart. Those randomized to the prostaglandin
arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per
hospital protocol. Those randomized to the oxytocin arm will receive infusion of oxytocin,
which will then be titrated per hospital protocol until adequate contractions. Further
management after the start of the respective arm will be based on clinical judgment of the
provider.
Inclusion Criteria:
1. All pregnant women diagnosed with PROM without evidence of labor requiring induction
2. Gestational Age > 34 weeks
3. Bishop score < 6
4. Category I Fetal heart rate tracing
Exclusion Criteria:
1. Contraindication to Induction of Labor
2. Multiple gestation
3. Fetal Anomalies
4. Previous C-Section
5. HIV Positive Patients
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Phone: 718-904-2767
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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