Back to resultsMisoprostol Before and After Cesarean Section
Primary Purpose
Post Partum Hemorrhage
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
rectal misoprostol 600mg
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Hemorrhage focused on measuring misoprostol, postpartum haemorrhage
Eligibility Criteria
Inclusion Criteria:
- Women not in active labor have reactive non-stress test.
- No contraindications to prostaglandins.
- Have no history of coagulopathy.
Exclusion Criteria:
- Placenta previa.
- Maternal hypertension.
- Diabetes mellitus.
- Previous CS and those with active labor.
- Multiple Fibroid uterus.
- Multiple pregnancies or polyhydramnios.
- Previous myomectomy, previous history of PPH.
Sites / Locations
- Kasr El Ainiy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
preoperative misoprostol group
postoperative misoprostol group
Arm Description
70 women who received 600 mg misoprostol rectally preoperatively before cesarean section
70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section
Outcomes
Primary Outcome Measures
intraoperative blood loss
Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)
postoperative blood loss
weighing the soaked napkins after collection of soaked towel
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03463070
Brief Title
Misoprostol Before and After Cesarean Section
Official Title
The Effect of Misoprostol Given Preoperative Versus Postoperative on Blood Loss With Elective Cesarean Section: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
sarah mohamed hassan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
comparison of the effect of misoprostol before and after cesarean on the blood loss
Detailed Description
70 women who received 600 mg misoprostol rectally preoperatively versus 70 women who received 600 mg misoprostol postoperatively at operating theatre
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
Keywords
misoprostol, postpartum haemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
preoperative misoprostol group
Arm Type
Active Comparator
Arm Description
70 women who received 600 mg misoprostol rectally preoperatively before cesarean section
Arm Title
postoperative misoprostol group
Arm Type
Active Comparator
Arm Description
70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section
Intervention Type
Drug
Intervention Name(s)
rectal misoprostol 600mg
Intervention Description
70 women who received 600 mg misoprostol postoperatively at operating theatre
Primary Outcome Measure Information:
Title
intraoperative blood loss
Description
Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)
Time Frame
the operation time
Title
postoperative blood loss
Description
weighing the soaked napkins after collection of soaked towel
Time Frame
every 6 hours during first 24 hours.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women not in active labor have reactive non-stress test.
No contraindications to prostaglandins.
Have no history of coagulopathy.
Exclusion Criteria:
Placenta previa.
Maternal hypertension.
Diabetes mellitus.
Previous CS and those with active labor.
Multiple Fibroid uterus.
Multiple pregnancies or polyhydramnios.
Previous myomectomy, previous history of PPH.
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Misoprostol Before and After Cesarean Section
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