The Effectiveness and Safety of the Trial of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor

Recruiting

• Conditions: Trial of Labor After Cesarean; Spontaneous Labor; Vaginal Birth After Cesarean

• Registration Number: NCT05215041
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This study is a multi-center, prospective, observational clinical trial study. 510 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 one prior cesarean section after spontaneous labor 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 after spontaneous labor but without vaginal labor contraindications will be enrolled. After spontaneous labor for 24h, 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: 2021-12-30
• Study First Submitted QC: 2022-01-17
• Study Start: 2022-01-28
• Study First Posted: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-17
• Last Update Posted: 2022-04-25
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 510

Inclusion Criteria

1. Volunteers sign the informed consent
2. Age: 20-40 years;
3. Singleton, a cephalic presentation;
4. No contradiction to vaginal delivery; 5.39~42 weeks; 6.Spontaneous labor

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

Primary Outcome Measures

Name	Time	Method
Vignial birth rate	24 hours	After spontaneous labor for up tp 24h, the mode of delivery will be konwn and recorded.

Trial Locations

Locations (1)

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