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Completed

NCT Number: NCT03016208

The Misoprostol Vaginal Insert for Labour Induction

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.

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Key information

Conditions

Labour Induction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol vaginal insert

Drug

Primary outcomes

  1. Time from induction to delivery in minutes

    Time frame: August 2016

  2. Rate of participants receiving a caesarean section compared to all participants being induced

    Time frame: August 2016

Secondary outcomes

  1. Number of participants with treatment-related tachysystole as assessed by cardiotocography

    Time frame: August 2016

  2. Number of participants with treatment-related adverse events following tocolysis with Partusisten

    Time frame: August 2016

  3. Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value

    Time frame: August 2016

Sponsors and collaborators

Lead sponsor

Asklepios Kliniken Hamburg GmbH

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 10, 2017
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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