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

NCT ID: NCT07258459

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2016 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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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')

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 2

term pregnant women with 2 previous CS from 01.01.2021 to 31.12.2025

Acceptance, rate of vaginal birth and safety

Intervention Type 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

Group 1

Women with a history of two previous CS in period 01.01.2026 - 31-12.2020

Acceptance, rate of vaginal birth and safety

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Claudio Celentano

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Claudio Celentano

Pescara, PE, Italy

Site Status RECRUITING

Santo Spirito Hospital

Pescara, PE, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Claudio Celentano, MD

Role: CONTACT

+39 328 5577305

Facility Contacts

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Claudio Celentano, MD

Role: primary

+393285577305

Maurizio Rosati, MD

Role: primary

+39 085 4252247

References

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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.

Reference Type RESULT
PMID: 40771829 (View on PubMed)

Other Identifiers

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ObGynEASC009

Identifier Type: -

Identifier Source: org_study_id

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