Trial · NCT02314728
Cervical Ripening in Premature Rupture of Membranes
NCT02314728, Not applicable, Completed, Montefiore Medical Center; results first posted 2021-08-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cervical Ripening in Premature Rupture of Membranes. Trials, record NCT02314728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02314728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cervical Ripening in Premature Rupture of Membranes
- NCT number
- NCT02314728
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 230 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Pregnancy, Premature Rupture of Membranes, Preterm Premature Rupture of Membranes, Unfavorable Cervix
- Interventions
- Misoprostol, Oxytocin
- First posted
- 2014-12-11
- Last updated
- 2021-08-10
- Results first posted
- 2021-08-10
- Limitations and caveats
1. Protocol breech~2. Variability in provider practices on labor and delivery. Reluctance to use misoprostol with rupture membranes.~3. Patient wait times impacted compliance with protocol. They went into labor while awaiting for a labor bed.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Cesarean Section | within 48 hours | Mode of delivery via cesarean section or vaginal delivery |
| Secondary | Maternal and Neonatal Infectious Morbidity | within 72 hours | Maternal infection defined as fever \>100.4 on at least two occasions during labor, continued antibiotic treatment on or after PPD#1, histologic confirmation of chorioamnionitis. Dose of Oxytocin, Tachysystole, Estimated blood loss at delivery, maternal length of stay, Epidural use, Indication for cesarean delivery Neonatal infection defined as WBC \<5000 and absolute neutrophil count \<1000 or positive blood cultures and neonatal fever, NICU admission, Apgar score less than 7 at 5 minutes, |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Cesarean Section | within 48 hours | participants | NUMBER | |
| SECONDARY | Maternal and Neonatal Infectious Morbidity | within 72 hours | Women induced for PROM at greater than, or equal to 34 weeks of gestation with unfavorable cervical examination (Bishop score \</= 6 and their neonates. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Cesarean Section | Vaginal Misoprostol | Cesarean Delivery | 27 | participants | |
| Rate of Cesarean Section | Oxytocin Alone | Cesarean Delivery | 26 | participants | |
| Rate of Cesarean Section | Vaginal Misoprostol | Vaginal Delivery | 89 | participants | |
| Rate of Cesarean Section | Oxytocin Alone | Vaginal Delivery | 86 | participants | |
| Maternal and Neonatal Infectious Morbidity | Vaginal Misoprostol | NICU Admission | 13 | Participants | |
| Maternal and Neonatal Infectious Morbidity | Oxytocin Alone | NICU Admission | 15 | Participants | |
| Maternal and Neonatal Infectious Morbidity | Vaginal Misoprostol | Histologic Chorioamnionitis | 9 | Participants | |
| Maternal and Neonatal Infectious Morbidity | Oxytocin Alone | Histologic Chorioamnionitis | 13 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaginal Misoprostol | 117 | |
| Overall Study | STARTED | Oxytocin Alone | 113 | |
| Overall Study | COMPLETED | Vaginal Misoprostol | 116 | |
| Overall Study | COMPLETED | Oxytocin Alone | 112 | |
| Overall Study | NOT COMPLETED | Vaginal Misoprostol | 1 | |
| Overall Study | NOT COMPLETED | Oxytocin Alone | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Misoprostol | 0 | 117 |
| Total, all-cause mortality | Oxytocin Alone | 0 | 113 |
| Total, other adverse events | Misoprostol | 0 | 117 |
| Total, other adverse events | Oxytocin Alone | 0 | 113 |
| Total, serious adverse events | Misoprostol | 0 | 117 |
| Total, serious adverse events | Oxytocin Alone | 0 | 113 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Misoprostol vs Oxytocin Alone: deaths from any cause | Trial comparisons |
| Misoprostol vs Oxytocin Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02314728
GET https://conductscience.org/api/trials/v1/NCT02314728/registered