NCT07258459

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

10 years

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Cesarean Delivery Affecting Fetus or NewbornLabor (Obstetrics)--ComplicationsHemorrhagic Complications

Keywords

previous CStrial of labormaternal outcomesfetal outcomesneonatal outcomes

Outcome Measures

Primary Outcomes (2)

  • vaginal birth after 2 cesarean

    Incidence of patients having a vaginal birth after 2 CS

    5 years

  • accepted indication to trial of labor

    incidence of women accepting indication to trial of labor

    5 years

Secondary Outcomes (3)

  • emergency CS

    5 years

  • maternal outcomes

    5 years

  • Fetal and Neonatal adverse outcomes

    5 years

Study Arms (2)

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

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

Interventions

Acceptance, rate of vaginal birth and safetyPROCEDURE

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 1Group 2

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Claudio Celentano

Pescara, PE, 65100, Italy

RECRUITING

Santo Spirito Hospital

Pescara, PE, 65123, Italy

RECRUITING

Related Publications (1)

  • Brandstetter M, Brandstetter A, Kainz-Schultes S, Jacobs VR, Fazelnia C, Fischer T, Bogner G. Successful Trial of Labor After Two Caesarean Sections (TOLA2C): Analysis of a Delivery Protocol with Feto-Maternal Outcome. Geburtshilfe Frauenheilkd. 2025 Feb 7;85(8):862-869. doi: 10.1055/a-2513-6562. eCollection 2025 Aug.

    PMID: 40771829RESULT

MeSH Terms

Interventions

Safety

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Central Study Contacts

Claudio Celentano, MD

CONTACT

+39 328 5577305celentanoclaudio70@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

January 1, 2016

Primary Completion

December 31, 2025

Study Completion

January 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)