Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols
NCT ID: NCT07258459
Last Updated: 2025-12-02
Study Results
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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RECRUITING
2016 participants
OBSERVATIONAL
2016-01-01
2026-01-01
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
FEMALE
No
Sponsors
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G. d'Annunzio University
OTHER
Responsible Party
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Claudio Celentano
MD
Locations
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Claudio Celentano
Pescara, PE, Italy
Santo Spirito Hospital
Pescara, PE, Italy
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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ObGynEASC009
Identifier Type: -
Identifier Source: org_study_id
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