Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section
NCT ID: NCT03148717
Last Updated: 2018-03-22
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
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2017-05-10
2018-03-20
Brief Summary
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2017\. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Preoperative
Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".
Misoprostol
Cytotec
Placebo
Placebo tablet similar in shape, odour and consistency to misoprostol tablet.
Postoperative
Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" .
Misoprostol
Cytotec
Placebo
Placebo tablet similar in shape, odour and consistency to misoprostol tablet.
Interventions
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Misoprostol
Cytotec
Placebo
Placebo tablet similar in shape, odour and consistency to misoprostol tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Full term pregnancies (GA 37- 42 Wks).
3. Age (18-40 yrs).
4. body mass index (BMI) (20-30(Kg/m2 .
Exclusion Criteia:
1. Contraindication to spinal anesthesia.
2. Blood dyscrasias.
3. Large fibroids.
4. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
5. Emergency CS such as fetal distress
6. Extreme of BMI (\<20 or \>30 Kg/m2 ).
18 Years
40 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed S Sweed, MD
Assistant Professor
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Other Identifiers
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AS1380
Identifier Type: -
Identifier Source: org_study_id
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