Trial · NCT03976063
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation
NCT03976063, Phase 3, Active not recruiting, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation. Trials, record NCT03976063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03976063
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation
- NCT number
- NCT03976063
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 857 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Preterm Premature Rupture of Membrane
- Interventions
- Nifedipine, Placebo of Nifedipine
- First posted
- 2019-06-05
- Last updated
- 2026-04-23
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Perinatal morti-morbidity | Up to discharge from hospital, with a maximum of 24 weeks after birth. | Composite outcome including fetal death, neonatal death and/or neonatal severe morbidity (mechanical ventilation ≥ 48 hrs, severe bronchopulmonary dysplasia, severe intraventricular hemorrhage, cystic periventricular leucomalacia, neonatal early-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity). |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Latency duration (defined as the duration from PPROM to delivery) |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Pregnancy prolongation beyond 48 hours after randomization |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Pregnancy prolongation beyond 1 week after randomization |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Gestational age at delivery |
| Secondary | Prolongation of gestation | Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Delivery after 37 weeks of gestation |
| Secondary | Maternal morbidity | During the first 10 days postpartum | Endometritis, based on clinical diagnosis associating fever (temperature ≥ 38.0°C) with uterine tenderness, purulent or foul-smelling lochia, and in the absence of any other cause. |
| Secondary | Maternal morbidity | At delivery | Intra-uterine infection, defined as fever (maternal temperature ≥38 °C), with no alternative cause identified, associated with at least two of the following criteria: persistent fetal tachycardia \> 160 bpm, uterine pain or painful uterine contractions or spontaneous labor, purulent amniotic fluid. |
| Secondary | Fetal mortality | Up to delivery so up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy) | Fetal death |
| Secondary | Neonatal mortality | From birth to discharge from hospital, with a maximum of 24 weeks after birth. | Neonatal death |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03976063
GET https://conductscience.org/api/trials/v1/NCT03976063/registered?page=2