Misoprostol for Second Trimester Termination of Pregnancy
NCT ID: NCT02048098
Last Updated: 2015-01-16
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
PHASE3
130 participants
INTERVENTIONAL
2014-01-31
2014-12-31
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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Buccal misoprostol
400 µg buccal misoprostol per 3 hours
Buccal misoprostol
400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
vaginal misoprostol
400 µg vaginal misoprostol per 3 hours
Vaginal misoprostol
400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
Interventions
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Vaginal misoprostol
400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
Buccal misoprostol
400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* live fetus
* singleton pregnancy
* Bishop score \<5
* no uterine contraction
Exclusion Criteria
* a scar in uterus
* uterine abnormality
* premature rupture of membranes
16 Years
45 Years
FEMALE
Yes
Sponsors
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Ataturk University
OTHER
Responsible Party
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Ragıp Atakan Al
Associate Professor
Principal Investigators
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Ragıp A AL, MD
Role: PRINCIPAL_INVESTIGATOR
Ataturk University Faculty of Medicine
Ömer E Yapça, MD
Role: STUDY_CHAIR
Ataturk University Faculty of Medicine
Locations
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Ataturk Universitesi Araştırma Hastanesi
Erzurum, , Turkey (Türkiye)
Countries
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References
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Al RA, Yapca OE. Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):593-598. doi: 10.1097/AOG.0000000000000946.
Other Identifiers
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atauni9
Identifier Type: -
Identifier Source: org_study_id
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