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Cervical Ripening in Premature Rupture of Membranes

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ClinicalTrials.gov Identifier: NCT02314728
Recruitment Status : Unknown
Verified March 2016 by Montefiore Medical Center.
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Premature Rupture of Membranes Preterm Premature Rupture of Membranes Drug: Misoprostol Drug: Oxytocin Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cervical Ripening in Premature Rupture of Membranes
Study Start Date : November 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Misoprostol
Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.
Drug: Misoprostol
Patients who are randomized to receive misoprostol will have 25mcg placed vaginally. Repeated dosing of misoprostol is based on clinical exam and clinical judgment of the provider.
Other Name: Cytotec

Active Comparator: Oxytocin Alone
Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.
Drug: Oxytocin
Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions.
Other Name: Pitocin




Primary Outcome Measures :
  1. Rate of Cesarean Section [ Time Frame: 18 months ]
    Mode of delivery via cesarean section or vaginal delivery


Secondary Outcome Measures :
  1. Maternal and Neonatal Infectious Morbidity [ Time Frame: 24 months ]
    Maternal infection defined as fever >100.4 on at least two occasions, continued antibiotic treatment on or after PPD#1 up to 6 weeks postpartum or pathological confirmation of infection. Neonatal infection defined as WBC <5000 and absolute neutrophil count <1000 or positive blood cultures and neonatal fever



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314728


Contacts
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Contact: Kafui Demasio, MD, MPH 718-904-2767 kafui5@netzero.net
Contact: Sasha Davidson, MD 718-904-2767 sdavidso@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Kafui Demasio, MD, MPH    718-904-2767    kafui5@netzero.net   
Contact: sasha Davidson, MD    718-904-2767    sdavidso@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Kafui Demasio, MD, MPH Montefiore Medical Center

Additional Information:
Publications of Results:

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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02314728     History of Changes
Other Study ID Numbers: 2014-3462
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Montefiore Medical Center:
Bishop Score
Induction of Labor
Cervical Ripening
Unfavorable Cervix
Mode of Delivery
C-Section
Cesarean Section

Additional relevant MeSH terms:
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Premature Birth
Rupture
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents