Trials / Unknown
UnknownNCT05333731
Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes
To Study the Effectiveness and Safety of Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes: a Multi-center, Prospective, Observational Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 528 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- Female
- Age
- 20 Years – 40 Years
- Healthy volunteers
- —
Summary
This study is a multi-center, prospective, observational clinical trial study. 528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the cesarean section group, full term pregnant women with prelabor rupture of membrane (PROM) who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the non-cesarean section group, pregnant women after 37 weeks of gestation with PROM but without vaginal labor contraindications will be enrolled. Whether in the cesarean section group or non-cesarean section group, if spontaneous labor does not occur, and they all will be induced by oxytocin. After 24 hours, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.
Conditions
- Failed Trial of Labor, Unspecified, With Delivery
- Failed VBAC (Vaginal Birth After Caesarean)
- Prelabor Rupture of Membranes
- Failed Induction (of Labor) by Oxytocin
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxytocin | In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h. |
Timeline
- Start date
- 2022-03-30
- Primary completion
- 2024-12-30
- Completion
- 2025-06-30
- First posted
- 2022-04-19
- Last updated
- 2022-04-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05333731. Inclusion in this directory is not an endorsement.