Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
NCT ID: NCT02762942
Last Updated: 2016-05-12
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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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2016-05-31
2017-09-30
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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Vaginal misoprostol alone
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols
Misoprostol
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
Vaginal misoprostol + Foley catheter
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol.
Misoprostol
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
Foley catheter
Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours
Interventions
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Misoprostol
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
Foley catheter
Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cephalic presentation
* Reassuring fetal heart rate pattern
* Intact membranes
* Bishop score less than 6
Exclusion Criteria
* Prematurity ( \< 37 weeks gestation dated by first trimester ultrasound)
* Previous cesarean section or previous uterine surgery
* Intrauterine growth restriction
* Premature rupture of membranes
* Maternal colonization with Streptococcus Agalactiae at any time during pregnancy
* Multifetal pregnancy
* Breech presentation
* Stillbirth
* Any contraindication for vaginal delivery
18 Years
FEMALE
No
Sponsors
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Consorci Sanitari de Terrassa
OTHER
Responsible Party
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Dra Angels Vives Argilagós
Obstetrician
Principal Investigators
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Àngels Vives Argilagós, MD
Role: PRINCIPAL_INVESTIGATOR
Consorci Sanitari de Terrassa
Locations
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Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
Other Identifiers
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2015-002061-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2015-002061-29
Identifier Type: -
Identifier Source: org_study_id
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