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

NCT05246761 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 924

Last updated 2022-04-22

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Balloon catheter

In the two groups, if their bishop score \<6, they will receive the cervical riening by the balloon catheter, and then the oxytocin if necessary.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Jiang Ziyan, Ph.D · Department of Obstetrics and Gynecology, First Affiliated Hospital of Nanjing Medical University

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-30
Primary Completion
2023-06-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05246761 on ClinicalTrials.gov