Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes

Recruiting

• Conditions: Failed Trial of Labor, Unspecified, With Delivery; Failed Induction (of Labor) by Oxytocin; Prelabor Rupture of Membranes; Failed VBAC (Vaginal Birth After Caesarean)
• Interventions: Drug: Oxytocin

• Registration Number: NCT05333731
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study Start: 2022-03-30
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-17
• Last Update Submitted: 2022-04-17
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 528

Inclusion Criteria

1. Volunteers sign the informed consent;
2. Age: 20-40 years;
3. Singleton, a cephalic presentation;
4. No contradiction to vaginal delivery;
5. gestation: 37~42 weeks;
6. With prelabor rupture of membrane.

Exclusion criteria:

1. Konwn contraindication to vaginal delivery or severe complications;
2. Multiple gestation;
3. Uterine malformation;
4. Severe psychiatric disorder;
5. Without family's support.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cesarean section group	Oxytocin	In the cesarean section group, all the pregnant women had only one prior cesarean section.
Non-cesarean section group	Oxytocin	In the non-cesarean section group, all the pregnant women are primipara, and never had a cesarean section.

Primary Outcome Measures

Name	Time	Method
Vignial birth rate	24 hours	After the treatment of oxytocin induction for up tp 24 hours, the mode of delivery will be konwn and recorded.

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China