Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02314728 · ClinicalTrials.gov registry record · NA
Cervical Ripening in Premature Rupture of Membranes
A NA study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 230
- Enrollment target
NCT02314728 is a NA study that has completed, run by Montefiore Medical Center. The registered enrollment target is 230 participants.
The verdict
NCT02314728, a NA study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 230 participants
- Enrollment target
Study 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 delive
Interventions
- DRUG Oxytocin
- DRUG Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2016-05-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02314728
The ClinicalTrials.gov registry entry for NCT02314728 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxytocin is the first listed.
NCT02314728 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02314728 about?
NCT02314728 is a clinical study titled "Cervical Ripening in Premature Rupture of Membranes". 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...
What is the current status of trial NCT02314728?
This trial is currently completed. It is a NA study. The enrollment target is 230 participants. The study started on 2014-10-01. Estimated completion is 2016-05-30.
What interventions are being tested in trial NCT02314728?
The interventions under investigation include: Oxytocin (DRUG), Misoprostol (DRUG).
Who is sponsoring clinical trial NCT02314728?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.