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

Recruiting

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

• Registration Number: NCT05246761
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study Start: 2022-01-30
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-17
• Last Update Posted: 2022-04-22
• Primary Completion: 2023-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 924

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-cesarean section group	Balloon catheter	In the non-cesarean section group, all the pregnant women are primipara，and never had a cesarean section.
Cesarean section group	Balloon catheter	In the cesarean section group, all the pregnant women had only one prior cesarean section.

Primary Outcome Measures

Name	Time	Method
vignial birth rate	up to 84 hours	After the treatment of balloon catheter for 12 hours +oxytocin induction for up tp 72 hours, the mode of delivery will be konwn and recorded.

Trial Locations

Locations (1)

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