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Completed

NCT Number: NCT07549971

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

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.)

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Key information

Conditions

Trial of Labor After Cesarean Trial of Labor; Failure

Age range

18 year–57 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women
  • previous CD

Exclusion criteria

  • below 34 weeks' gestation
  • medical indication to CD

Treatment and study plan

repetitive elective CD

Procedure

maternal and neonatal outcomes

Primary outcomes

  1. incidence of maternal request for trial of labor

    Time frame: 11 years

    incidence of women with request of trial of labor through the time

  2. incidence of VBAC

    Time frame: 11 years

    number of vaginal birth through the time

Secondary outcomes

  1. maternal adverse outcome

    Time frame: 11 years

    maternal adverse outcome such as PPH, emergency CS, surgical complications

  2. neonatal adverse outcome

    Time frame: 11 years

    NICU stay, low APGAR score (<7 at 5'), fetal death

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

Trial of Labor After Cesarean

Acronym: TOLAC

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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