The Misoprostol Vaginal Insert for Labour Induction
- Registration Number
- NCT03016208
- Lead Sponsor
- Asklepios Kliniken Hamburg GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 138
- 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
- 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
- glaucoma
- fetal congenital abnormalities
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Misoprostol vaginal insert for max. 24hrs Misoprostol vaginal insert 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours Misoprostol vaginal insert for max. 10hrs Misoprostol vaginal insert 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours
- Primary Outcome Measures
Name Time Method Rate of participants receiving a caesarean section compared to all participants being induced August 2016 Time from induction to delivery in minutes August 2016
- Secondary Outcome Measures
Name Time Method 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