Trial of Labor After One Cesarean Section a Cross-sectional Study After Protocol Introduction (TOLAC)

April 17, 2026 updated by: Claudio Celentano, G. d'Annunzio University

Trial of Labor After Cesarean

in 2015 a protocol for trail of labor after a single cesarean delivery was approved by medical committee of Pescara Hospital. A database from outpatient clinic evaluated all women after 34 weeks' gestation with a previous cesarean delivery. Patients with a specific medical indication for cesarean delivery were skipped, whilst the others were recruited within repetitive elective cesarean delivery or trial of labor based on maternal request. Patients were couselled on the opportunity of having a mechanical induction/ rupture of membranes and subsequent oxytocin infusion if needed due to prolonged gestation (above 41 weeks plus 3 days) or medical indication to delivery (i.e. gestational diabetes, hypertension, SGA, etc.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All pregnant women with a previous CD attending Labor Ward of Santo Spirito Hospital of Pescara Italy (affiliated to University of Chieti Pescara) were enrolled at outpatient clinic after internal protocol registration for trial of labor in previus cesarean delivery. Patinets with a medical indication to CD were not elegible. Sociodemographic data such as ethnic background, maternal age, gestational age at delivery, previous vaginal birth, indications to previous CD, and maternal willingness to RECD ot TOLAC were recorded.

Maternal decision to switch to different intervention were recorded. Outcome of RECD and TOLAC were recorded.

Study Type

Observational

Enrollment (Actual)

1200

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All prengnat women attending labor ward of Santo Spirito Hospital of Pescara (Italy)

Description

Inclusion Criteria:

  • pregnant women
  • previous CD

Exclusion Criteria:

  • below 34 weeks' gestation
  • medical indication to CD

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of maternal request for trial of labor
Time Frame: 11 years
incidence of women with request of trial of labor through the time
11 years
incidence of VBAC
Time Frame: 11 years
number of vaginal birth through the time
11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal adverse outcome
Time Frame: 11 years
maternal adverse outcome such as PPH, emergency CS, surgical complications
11 years
neonatal adverse outcome
Time Frame: 11 years
NICU stay, low APGAR score (<7 at 5'), fetal death
11 years

Collaborators and Investigators

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

Sponsor

G. d'Annunzio University

Investigators

  • Principal Investigator: Claudio Celentano, MD, University of Chieti Pescara School of Medicine

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 1, 2015

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ObGynEASC010
  • ASL register (Other Identifier: ASL PE Italy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

depends on the request

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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