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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

Tracking Information
First Submitted Date January 8, 2017
First Posted Date January 10, 2017
Last Update Posted Date January 11, 2017
Study Start Date May 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2017)
  • Time from induction to delivery in minutes [ Time Frame: August 2016 ]
  • Rate of participants receiving a caesarean section compared to all participants being induced [ Time Frame: August 2016 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 8, 2017)
  • Number of participants with treatment-related tachysystole as assessed by cardiotocography [ Time Frame: August 2016 ]
  • Number of participants with treatment-related adverse events following tocolysis with Partusisten [ Time Frame: August 2016 ]
  • Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value [ Time Frame: August 2016 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Misoprostol Vaginal Insert for Labour Induction
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Condition Labour Induction
Intervention Drug: Misoprostol vaginal insert
Study Groups/Cohorts
  • Misoprostol vaginal insert for max. 24hrs
    69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours
    Intervention: 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
    Intervention: Drug: Misoprostol vaginal insert
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 8, 2017)
138
Original Actual Enrollment Same as current
Actual Study Completion Date May 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03016208
Other Study ID Numbers Miso2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Peter Schwaerzler, Asklepios Kliniken Hamburg GmbH
Study Sponsor Asklepios Kliniken Hamburg GmbH
Collaborators Not Provided
Investigators Not Provided
PRS Account Asklepios Kliniken Hamburg GmbH
Verification Date January 2017