Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols (TOLA2C Train)

November 20, 2025 updated by: Claudio Celentano, G. d'Annunzio University

Trial of Labor After Two CS Before and After Training a Protocol Introduction

In 2015 ObGyn Dept of Santo Spirito Hospital in Pescara (Italy) started protocol for previous CS vaginal birth. In 2021 was started a protocol for training on obstetric emergencies and protocol on two previous cesarean was endorsed. Patients attending birth in Pescara with two previous from january 2016 to December 2020, and from january 2021 to december 2025 were collected. A different counseling approach was adopted from 2021. Women's acceptance of trial of labor and maternal and fetal outcomes were collected.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Women attending birth in Santo Spirito Hospital with 2 previous CS were collected.

Exclusion Criteria:

  • Patients with clinical indication to CS
  • a previous CS less than 18 month before
  • breech presentations
  • triplets
  • premature labor before 34 completed weeks' gestation The first period was starting January 1st 2016 to December 31st 2020. The second period was starting January 1st 2021 to December 31st 2025

Primary outcomes:

  • incidence of trial of labor acceptance
  • incidence of vaginal birth

Secondary outcomes:

  • maternal adverse outcomes (PPH, blood transfusion, vaginal tears, hysterectomy, maternal death)
  • fetal adverse outcomes (fetal death, NICU stay, APGAR score less than 7 at 5')

Study Type

Observational

Enrollment (Estimated)

2016

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
    • PE
      • Pescara, PE, Italy, 65100
      • Pescara, PE, Italy, 65123

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

pregnant women attending birth in Santo Spirito Hospital Pescara (Italy) from 01-01-2016 to 31-12-2025

Description

Inclusion Criteria:

  • pregnant women
  • pregnancy above 34 weeks' gestation
  • cephalic presentation of the fetus
  • singleton and twins
  • diamniotic twins
  • 2 previous CS
  • more than 18 months from last CS
  • no other indication to CS

Exclusion Criteria:

  • pregnancy below 34 weeks' gestation
  • breech baby
  • triplets or high order multiple pregnancies
  • more than 2 previous CS
  • less than 18 months from last CS
  • precence of other indications to CS (i.e. maternal diseases, placenta previa, etc.)

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
Group 2
term pregnant women with 2 previous CS from 01.01.2021 to 31.12.2025
Procedure: Acceptance, rate of vaginal birth and safety
In 2021 started a new delivery protocol enhancing the opportunity of having a trial of labor in women with a history of two previous CS. Rate of acceptance, rate of successful vaginal birth, maternal and fetal outcomes were evaluated
Group 1
Women with a history of two previous CS in period 01.01.2026 - 31-12.2020
Procedure: Acceptance, rate of vaginal birth and safety
In 2021 started a new delivery protocol enhancing the opportunity of having a trial of labor in women with a history of two previous CS. Rate of acceptance, rate of successful vaginal birth, maternal and fetal outcomes were evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vaginal birth after 2 cesarean
Time Frame: 5 years
Incidence of patients having a vaginal birth after 2 CS
5 years
accepted indication to trial of labor
Time Frame: 5 years
incidence of women accepting indication to trial of labor
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergency CS
Time Frame: 5 years
incidence of emergency CS
5 years
maternal outcomes
Time Frame: 5 years
incidence of adverse maternal outcomes (PPH, blood transfusion, vaginal tears, hysterectomy)
5 years
Fetal and Neonatal adverse outcomes
Time Frame: 5 years
Incidence of fetal/neonatal death, NICU stay, APGAR score below 7 at 5'
5 years

Collaborators and Investigators

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

Sponsor

G. d'Annunzio 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 1, 2016

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ObGynEASC009

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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