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

Nanjing Medical University

Status: Enrolling

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

Treatments: Other: Non intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05215041

JPPTOLAC-03

Details and patient eligibility

About

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.

Enrollment: 510 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

510 participants in 2 patient groups

Cesarean section group

Treatment:

Other: Non intervention

Non-cesarean section group

Treatment:

Other: Non intervention