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

Nanjing Medical University

Status: Enrolling

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

Treatments: Drug: Oxytocin

Study type: Observational

Funder types: Other

Identifiers

NCT05333731

JPPTOLAC-02

Details and patient eligibility

About

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.

Enrollment: 528 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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. 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.

Trial design

528 participants in 2 patient groups

Cesarean section group

Description:

In the cesarean section group, all the pregnant women had only one prior cesarean section.

Treatment:

Drug: Oxytocin

Non-cesarean section group

Description:

In the non-cesarean section group, all the pregnant women are primipara, and never had a cesarean section.

Treatment:

Drug: Oxytocin