The Misoprostol Vaginal Insert for Labour Induction
1 other identifier
observational
138
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 8, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedJanuary 11, 2017
January 1, 2017
7 months
January 8, 2017
January 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Time from induction to delivery in minutes
August 2016
Rate of participants receiving a caesarean section compared to all participants being induced
August 2016
Secondary Outcomes (3)
Number of participants with treatment-related tachysystole as assessed by cardiotocography
August 2016
Number of participants with treatment-related adverse events following tocolysis with Partusisten
August 2016
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
August 2016
Study Arms (2)
Misoprostol vaginal insert for max. 24hrs
69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours
Misoprostol vaginal insert for max. 10hrs
69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours
Interventions
Eligibility Criteria
A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 8, 2017
First Posted
January 10, 2017
Study Start
May 1, 2015
Primary Completion
December 1, 2015
Study Completion
May 1, 2016
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share