Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols (TOLA2C Train)

G. d'Annunzio University

Status: Enrolling

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

Treatments: Procedure: Acceptance, rate of vaginal birth and safety

Study type: Observational

Funder types: Other

Identifiers

NCT07258459

ObGynEASC009

Details and patient eligibility

About

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.

Full 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')

Enrollment: 2,016 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

2,016 participants in 2 patient groups

Group 2

Description:

term pregnant women with 2 previous CS from 01.01.2021 to 31.12.2025

Treatment:

Procedure: Acceptance, rate of vaginal birth and safety

Group 1

Description:

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

Treatment:

Procedure: Acceptance, rate of vaginal birth and safety