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

Trial of Labor After Two CS Before and After Training a Protocol Introduction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07258459
Acronym
TOLA2C Train
Enrollment
2016
Registered
2025-12-02
Start date
2016-01-01
Completion date
2026-01-01
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

previous CS, trial of labor, maternal outcomes, fetal outcomes, neonatal outcomes

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.

Detailed description

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')

Interventions

PROCEDUREAcceptance, 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

Sponsors

G. d'Annunzio University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
vaginal birth after 2 cesarean5 yearsIncidence of patients having a vaginal birth after 2 CS
accepted indication to trial of labor5 yearsincidence of women accepting indication to trial of labor

Secondary

MeasureTime frameDescription
emergency CS5 yearsincidence of emergency CS
maternal outcomes5 yearsincidence of adverse maternal outcomes (PPH, blood transfusion, vaginal tears, hysterectomy)
Fetal and Neonatal adverse outcomes5 yearsIncidence of fetal/neonatal death, NICU stay, APGAR score below 7 at 5'

Countries

Italy

Contacts

Primary ContactClaudio Celentano, MD
celentanoclaudio70@gmail.com+39 328 5577305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026