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Misoprostol for Labour Induction

NCT02904317 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2016-09-16

No results posted yet for this study

Summary

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.

Conditions

  • Labour Induction

Sponsors & Collaborators

  • Asklepios Kliniken Hamburg GmbH

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-09-30
Completion
2016-01-31

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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 NCT02904317 on ClinicalTrials.gov