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The Misoprostol Vaginal Insert for Labour Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016208
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Schwaerzler, Asklepios Kliniken Hamburg GmbH

Brief 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.


Condition or disease Intervention/treatment
Labour Induction Drug: Misoprostol vaginal insert

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Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Cohort
Official Title: The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Criteria

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
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Responsible Party: Peter Schwaerzler, Principal investigator, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier: NCT03016208    
Other Study ID Numbers: Miso2017
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics