Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section

Nanjing Medical University

Status: Enrolling

Conditions: Balloon Catheter for Labor Induction; Bishop Score; Unfavorable Cervix; Failed Mechanical Induction; Vaginal Birth After Cesarean; Trial of Labor After Cesarean

Treatments: Device: Balloon catheter

Study type: Observational

Funder types: Other

Identifiers

NCT05246761

JPPTOLAC-01

Details and patient eligibility

About

This study is a multi-center, prospective, observational clinical trial study. 924 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the prior cesarean section group, pregnant women with one previous cesarean section who are willing to try to 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 control group, pregnant women after 39 weeks of gestation without vaginal labor contraindications will be enrolled. Whether in the experimental group or the control group, their cervical bishop score was less than 6 points, and they all will be induced by balloon catheter + oxytocin. After 96h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.

Enrollment: 924 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.

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

924 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:

Device: Balloon catheter

Non-cesarean section group

Description:

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

Treatment:

Device: Balloon catheter