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
EARLY_PHASE1
40 participants
INTERVENTIONAL
2022-12-01
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group 1
Intramuscular administration of 20 milligrams hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company, plus misoprostol under the generic name of misotac tablets, each of wich is 200 micrograms produced by Sigma company, approximately 400 micrograms (2 tablets) given by a member of the study team according to FIGO guidelines for use of misoprostol 2019 and to have a halved dose to 200 micrograms if patient with history of one or two cesarean section.
Misoprostol only will be repeated every 4 hours for maximum 5 doses.
hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
misoprostol under the generic name of misotac tablets
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
Group 2
Administration of misoprostol under generic name of misotac tablets each one is 200 micrograms produced by Sigma company, about 400 micrograms (2 tablets) given by a member of the study team according to FIGO guidelines use of misoprostol 2019 and to have a halved dose if patient with history of one or two cesarean sections.
Misoprostol only will be repeated every 4 hours for maximum 5 doses.
misoprostol under the generic name of misotac tablets
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
Interventions
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hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
misoprostol under the generic name of misotac tablets
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Women have up to two cesarean sections.
Exclusion Criteria
2. Women who have had two or more caesarean sections.
3. Multiple pregnancies
4. Uterine anomalies, such as septate and didelphis uteri.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Andrew Nader Sed
Doctor
Principal Investigators
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Rania G Anwar El-Skaan
Role: STUDY_DIRECTOR
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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References
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Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.
Stephenson ML, Wing DA. A novel misoprostol delivery system for induction of labor: clinical utility and patient considerations. Drug Des Devel Ther. 2015 Apr 22;9:2321-7. doi: 10.2147/DDDT.S64227. eCollection 2015.
Related Links
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Effect of hyoscine butylbromide on cervical dilation during labor Medicina Universitaria
Other Identifiers
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Abortion
Identifier Type: -
Identifier Source: org_study_id
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