Successful Trial of Labor After Two Caesarean Sections (TOLA2C): Analysis of a Delivery Protocol with Feto-Maternal Outcome.
Maximilian Brandstetter, Andreas Brandstetter, Sabine Kainz-Schultes...
https://pubmed.ncbi.nlm.nih.gov/40771829Actively Recruiting
Age: 18Years +
FEMALE
ID07258459
Trial of Labor After Two Cesarean Sections Before and After Training Protocol Introduction
Led by G. d'Annunzio University · Updated on 2025-12-02
2016
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on women who have previously had two cesarean sections and are attending birth at Santo Spirito Hospital. It compares outcomes before and after introducing a new training and protocol starting in 2021 aimed at encouraging trial of labor after cesarean (TOLAC). The study collects data on women's acceptance of TOLAC and maternal and fetal outcomes to understand the effects of the new approach. The study includes two time periods: from January 2016 to December 2020, and from January 2021 to December 2025. Starting in 2021, a new delivery protocol was implemented to enhance opportunities for trial of labor in women with two previous cesarean sections. Researchers evaluate acceptance rates, vaginal birth rates, and safety outcomes for both mothers and babies during these periods. Participants are pregnant women with two previous cesarean sections, carrying single or diamniotic twins in cephalic presentation and above 34 weeks of gestation. During the study, maternal outcomes such as postpartum hemorrhage, blood transfusion, vaginal tears, hysterectomy, and maternal death are monitored alongside fetal outcomes including fetal death, neonatal intensive care unit stays, and low APGAR scores at 5 minutes. Researchers compare these outcomes between the two periods to assess the impact of the new protocol.
CONDITIONS
Brief Title
Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant women
- Pregnancy above 34 weeks' gestation
- Fetus in cephalic (head-down) presentation
- Singleton or diamniotic twins
- Exactly 2 previous cesarean sections
- More than 18 months since last cesarean
- No other medical indication for cesarean section
You will not qualify if you...
- Pregnancy below 34 weeks' gestation
- Breech baby presentation
- Triplets or higher order multiple pregnancies
- More than 2 previous cesarean sections
- Less than 18 months since last cesarean
- Presence of other medical indications for cesarean (e.g., maternal diseases, placenta previa)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to delivery and immediate postpartum period
Participants who meet eligibility criteria are observed during their pregnancy and delivery to evaluate acceptance of trial of labor, rates of vaginal birth, and maternal and fetal safety outcomes.
Visits as part of routine prenatal care and delivery
Trial Site Locations
Total: 2 locations
1
Claudio Celentano
Pescara, PE, Italy, 65100
Actively Recruiting
2
Santo Spirito Hospital
Pescara, PE, Italy, 65123
Actively Recruiting
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Research Team
C
Claudio Celentano, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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