Vaginal birth after two previous cesareans before and after new training and protocols
Trial of Labor After Two CS Before and After Training a Protocol Introduction
See if introducing new staff training and counseling protocols increased acceptance of trial of labor and the rate of vaginal birth among pregnant women with two prior cesarean deliveries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2016 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | G. d'Annunzio University Academic / other |
| Locations | 2 sites (Pescara, PE and 1 other locations) |
| Trial ID | NCT07258459 on ClinicalTrials.gov |
What this trial studies
This observational comparison collected women with two prior cesarean sections who delivered at Santo Spirito Hospital in Pescara before (2016–2020) and after (2021–2025) implementation of obstetric emergency training and a specific counseling protocol. Investigators recorded acceptance of trial of labor, vaginal birth rates, and maternal and neonatal adverse outcomes such as postpartum hemorrhage, transfusion, hysterectomy, fetal death, NICU admission, and low 5-minute Apgar. Eligible participants were ≥34 weeks' gestation with cephalic presentation and at least 18 months since the last cesarean, including singleton or diamniotic twin pregnancies, while cases with other indications for cesarean, breech, triplets, or gestation <34 weeks were excluded. The analysis compares acceptance and safety outcomes before and after the training and protocol change to see if counseling and staff preparation altered clinical practice and results.
Who should consider this trial
Good fit: Pregnant women with two prior cesarean sections, at least 18 months since the last cesarean, gestational age ≥34 weeks, cephalic presentation, and no other indication for cesarean (including singleton or diamniotic twins).
Not a fit: Women with clinical indications for cesarean such as placenta previa, less than 18 months since the last cesarean, breech or triplet presentations, or other contraindications are unlikely to benefit from trial of labor approaches studied here.
Why it matters
Potential benefit: If successful, the protocols could increase safe vaginal births and reduce repeat cesarean deliveries for women with two prior cesareans.
How similar studies have performed: Prior studies show trial of labor after cesarean (TOLAC) can be safe for selected patients, but evidence specifically addressing women with two prior cesareans is limited and has mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Pescara, PE and 1 other locations
- Claudio Celentano — Pescara, Pe, Italy (Recruiting)
- Santo Spirito Hospital — Pescara, Pe, Italy (Recruiting)
Study contacts
- Study coordinator: Claudio Celentano, MD
- Email: celentanoclaudio70@gmail.com
- Phone: +39 328 5577305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.