The Misoprostol Vaginal Insert Compared With Oral Misoprostol for Labour Induction in Term Pregnancies: a Pair-matched 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
- time from application of the medication until delivery in minutes
研究概览
简要总结
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an off-label use of oral misoprostol (OM).
Design: Pair-matched case-control study.
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction.
Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a consecutive series of 69 women was compared with induction using oral misoprostol in a pair-matched cohort.
Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.
详细描述
Open, non-interventional study in a tertiary referral center in Germany N/A The rationale of our observational study is to describe the efficacy and safety profile of the drug with definition of active labor according to local clinical practice in a descriptive observational study in a tertiary referral center.
A time interval from induction of labor to delivery is depending on the duration of the MISODEL® application. By an observational study the investigators want to describe the efficacy and safety with regard to time to delivery and complication rate.
Primary Objective:
The aim of this study is to describe time to vaginal delivery with definition of active labor according to local clinical practice.
The time period needed to induce any delivery and to describe the drug safety profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
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
- •gynaecologist'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 previa
- •chorioamnionitis
- •antepartum bleeding of unknown aetiology
- •cardiopulmonary, renal, hepatic maternal disease glaucoma
- •fetal congenital abnormalities
结局指标
主要结局
time from application of the medication until delivery in minutes
时间窗: September 2015
次要结局
- Rate of participants receiving a caesarean section compared to all participants being induced(September 2015)
- Number of participants with treatment-related tachysystole as assessed by cardiotocography(September 2015)
- Number of participants with treatment-related adverse events following tocolysis with Partusisten(September 2015)
- Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value(September 2015)
研究者
Peter Schwaerzler
Principal investigator
Asklepios Kliniken Hamburg GmbH