Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07258459

Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cesarean Delivery Affecting Fetus or Newborn Hemorrhagic Complications Labor (Obstetrics)--Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Claudio Celentano, Pescara, PE, Italy

Loading trial locations.

About this study

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')

Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

Acceptance, rate of vaginal birth and safety

Procedure

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

Primary outcomes

  1. vaginal birth after 2 cesarean

    Time frame: 5 years

    Incidence of patients having a vaginal birth after 2 CS

  2. accepted indication to trial of labor

    Time frame: 5 years

    incidence of women accepting indication to trial of labor

Secondary outcomes

  1. emergency CS

    Time frame: 5 years

    incidence of emergency CS

  2. maternal outcomes

    Time frame: 5 years

    incidence of adverse maternal outcomes (PPH, blood transfusion, vaginal tears, hysterectomy)

  3. Fetal and Neonatal adverse outcomes

    Time frame: 5 years

    Incidence of fetal/neonatal death, NICU stay, APGAR score below 7 at 5'

Study contacts

Contact information is provided by the study sponsor or research team.

Claudio Celentano, MD

CONTACT

[email protected]

+39 328 5577305

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Acronym: TOLA2C Train

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.