Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
138 participants
OBSERVATIONAL
2015-05-31
2016-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
Study Groups
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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
Misoprostol vaginal insert for max. 10hrs
69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours
Misoprostol vaginal insert
Interventions
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Misoprostol vaginal insert
Eligibility Criteria
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Inclusion Criteria
* informed consent
* ≥ 37 weeks of gestation
* singleton pregnancies
* cephalic presentation
* cervical Bishop score of \< 5 before priming reassuring fetal heart rate
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Asklepios Kliniken Hamburg GmbH
OTHER
Responsible Party
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Peter Schwaerzler
Principal investigator
Other Identifiers
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Miso2017
Identifier Type: -
Identifier Source: org_study_id
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