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The Misoprostol Vaginal Insert for Labour Induction

NCT03016208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2017-01-11

No results posted yet for this study

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.

Conditions

  • Labour Induction

Interventions

DRUG

Misoprostol vaginal insert

Sponsors & Collaborators

  • Asklepios Kliniken Hamburg GmbH

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016208 on ClinicalTrials.gov