The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- Rate of participants receiving a caesarean section compared to all participants being induced
研究概览
简要总结
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.
Design: Non-interventional observational case control study.
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Methods: Induction of labour with MVI in a consecutive series of women using standard (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.
Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. The secondary outcomes included the need for additional measures to induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •gynecologist's indication for induction
- •informed consent
- •≥ 37 weeks of gestation
- •singleton pregnancies
- •cephalic presentation
- •cervical Bishop score of < 5 before priming reassuring fetal heart rate
排除标准
- •known hypersensitivity to prostaglandins
- •uterine scar
- •parity > 5
- •any contraindication for vaginal delivery
- •cephalopelvic disproportion
- •placenta praevia
- •chorioamnionitis
- •antepartum bleeding of unknown etiology
- •cardiopulmonary, renal, hepatic maternal disease
- •fetal congenital abnormalities
研究组 & 干预措施
Misoprostol vaginal insert for max. 24hrs
69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours
干预措施: Misoprostol vaginal insert (Drug)
Misoprostol vaginal insert for max. 10hrs
69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours
干预措施: Misoprostol vaginal insert (Drug)
结局指标
主要结局
Rate of participants receiving a caesarean section compared to all participants being induced
时间窗: August 2016
Time from induction to delivery in minutes
时间窗: August 2016
次要结局
- Number of participants with treatment-related tachysystole as assessed by cardiotocography(August 2016)
- Number of participants with treatment-related adverse events following tocolysis with Partusisten(August 2016)
- Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value(August 2016)
研究者
Peter Schwaerzler
Principal investigator
Asklepios Kliniken Hamburg GmbH