NCT05215041

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

To Study the Effectiveness and Safety of the Trail of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor: a Multi-center, Prospective, Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 510 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Trial of Labor After Cesarean
• Vaginal Birth After Cesarean
• Spontaneous Labor

Interventions

Type	Name	Description
OTHER	Non intervention	If the vaginal delivery is failed after spontaneous labor for up to 24h, they will receive cesarean section

Timeline

• Start date: 2022-01-28
• Primary completion: 2024-12-30
• Completion: 2025-06-30
• First posted: 2022-01-31
• Last updated: 2022-04-25

Locations

1 site across 1 country: China