The Misoprostol Vaginal Insert for Labour Induction

January 9, 2017 updated by: Peter Schwaerzler, Asklepios Kliniken Hamburg GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Misoprostol vaginal insert for max. 24hrs
69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours
Drug: Misoprostol vaginal insert
Misoprostol vaginal insert for max. 10hrs
69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours
Drug: Misoprostol vaginal insert

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related tachysystole as assessed by cardiotocography
Time Frame: August 2016
August 2016
Number of participants with treatment-related adverse events following tocolysis with Partusisten
Time Frame: August 2016
August 2016
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
Time Frame: August 2016
August 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios Kliniken Hamburg GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 8, 2017

First Submitted That Met QC Criteria

January 8, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Miso2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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