Trial of Labor After Two CS Before and After Training a Protocol Introduction
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- G. d'Annunzio University
- 入组人数
- 2,016
- 试验地点
- 2
- 主要终点
- vaginal birth after 2 cesarean
概览
简要总结
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.
详细描述
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')
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
vaginal birth after 2 cesarean
时间窗: 5 years
Incidence of patients having a vaginal birth after 2 CS
accepted indication to trial of labor
时间窗: 5 years
incidence of women accepting indication to trial of labor
次要结局
- emergency CS(5 years)
- maternal outcomes(5 years)
- Fetal and Neonatal adverse outcomes(5 years)
研究者
Claudio Celentano
MD
G. d'Annunzio University