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

April 17, 2022 updated by: The First Affiliated Hospital with Nanjing Medical University

To Study the Effectiveness and Safety of Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section: Multicenter, Prospective, Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

924

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

In the cesarean section group, the extra inclusion criteria includes:

Only one prior low transverse uterine incision;

Extra exclusion criteria:

  1. With mutiple history of c esction;
  2. Prior extensive transfundal uterine surgery, such as for fetal surgery, myomectomy, or uterine reconstruction; Prior classical vertical uterine incision, or an inverted "T" or "J" incision;
  3. Short interpregnancy interval;
  4. Prior uterine rupture or dehiscence, or cesarean scar pregnancy;
  5. Evaluated fetal birth weight> 4000 g. In the non-cesarean section group, the extra criteria should include: nulliparous

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vignial birth rate
Time Frame: 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.
up to 84 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2022

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (ACTUAL)

February 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 17, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • JPPTOLAC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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