Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-31 @ 7:54 PM
Study NCT ID:
NCT07258459
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols
Sponsor:
G. d'Annunzio University
Organization:
Study Overview
Official Title:
Trial of Labor After Two CS Before and After Training a Protocol Introduction
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOLA2C Train
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')
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')
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: