Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour
NCT ID: NCT02539199
Last Updated: 2018-04-18
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
PHASE4
270 participants
INTERVENTIONAL
2015-09-30
2018-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Misoprostol modified-release pessary
Misoprostol, modified-release pessary
Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours
Misoprostol, per-oral tablets
Misoprostol, per-oral tablets
First day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced.
Interventions
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Misoprostol, modified-release pessary
Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours
Misoprostol, per-oral tablets
First day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton at term pregnancy (\>36+6 weeks)
* Unfavourable cervix (Bishop score \< 6)
* Fetal cephalic position
Exclusion Criteria
* Multiple pregnancy
* Rupture of membranes
* Other than fetal cephalic position
* Intra-uterine growth retardation
* Severe pre-eclampsia
* Severe hypertension
* Previous cesarean section
FEMALE
No
Sponsors
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Helsinki University Central Hospital
OTHER
Oulu University Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Principal Investigators
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Kati Tihtonen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Locations
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Helsinki University hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Other Identifiers
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2015-001972-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R15109M
Identifier Type: -
Identifier Source: org_study_id
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