The Effectiveness and Safety of the Trial of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor

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

To Study the Effectiveness and Safety of the Trail of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor: a Multi-center, Prospective, Observational Study

This study is a multi-center, prospective, observational clinical trial study. 510 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 one prior cesarean section after spontaneous labor 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 after spontaneous labor but without vaginal labor contraindications will be enrolled. After spontaneous labor for 24h, 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)

510

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;4.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; 6.Spontaneous labor

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
Other: Non intervention
If the vaginal delivery is failed after spontaneous labor for up to 24h, they will receive cesarean section
Non-cesarean section group
Other: Non intervention
If the vaginal delivery is failed after spontaneous labor for up to 24h, they will receive cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vignial birth rate
Time Frame: 24 hours
After spontaneous labor for up tp 24h, the mode of delivery will be konwn and recorded.
24 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 28, 2022

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 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-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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