The Misoprostol Vaginal Insert for Labour Induction

Study Overview
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Brief Summary
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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.

Official Title
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The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study

Conditions
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Labour Induction

Intervention / Treatment
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* Drug: Misoprostol vaginal insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Misoprostol vaginal insert for max. 24hrs<br>69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours | Drug: Misoprostol vaginal insert<br> <br> |
| Misoprostol vaginal insert for max. 10hrs<br>69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours | Drug: Misoprostol vaginal insert<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from induction to delivery in minutes |  | August 2016 | 
| Rate of participants receiving a caesarean section compared to all participants being induced |  | August 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |