Back to resultsProstaglandins Before Caserean Section
Primary Purpose
Intrapartum Hemorrhage
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol 200Mcg Tab
elective cesarean section
Sponsored by
About this trial
This is an interventional prevention trial for Intrapartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:pregnant patients full term elective cesarean section
-
Exclusion Criteria:
- medical disorder with pregnancy
Sites / Locations
- Kasr El Ainiy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group A (Misoprostol group)
Group B (control group)
Arm Description
200 mcg rectal Misoprostol administration before cesarean section
No prostaglandins administration before cesarean section
Outcomes
Primary Outcome Measures
amount of intraoperative blood loss
number of soaked towels
postpartum hemorrhage
blood loss after cesarean section
Secondary Outcome Measures
fetal condition
apgar score
Full Information
NCT ID
NCT03366259
First Posted
December 4, 2017
Last Updated
December 7, 2017
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03366259
Brief Title
Prostaglandins Before Caserean Section
Official Title
Does the Administration of Prostaglandins Before Cesarean Section Reduce the Amount of Blood Loss ?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
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
The aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of blood loss
Detailed Description
160 full term pregnant patients candidate for elective cesarean section were randomly allocated into 2 groups ,80 patients will receive 200mcg of rectal prostaglandins before cesarean section and 80 patients are used as control receiving placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrapartum Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (Misoprostol group)
Arm Type
Active Comparator
Arm Description
200 mcg rectal Misoprostol administration before cesarean section
Arm Title
Group B (control group)
Arm Type
Placebo Comparator
Arm Description
No prostaglandins administration before cesarean section
Intervention Type
Drug
Intervention Name(s)
Misoprostol 200Mcg Tab
Intervention Description
administration of 200 Mcg of misoprotol rectal
Intervention Type
Procedure
Intervention Name(s)
elective cesarean section
Intervention Description
elective cesarean section for full term patients
Primary Outcome Measure Information:
Title
amount of intraoperative blood loss
Description
number of soaked towels
Time Frame
during cesarean section
Title
postpartum hemorrhage
Description
blood loss after cesarean section
Time Frame
24 hour after cesarean section
Secondary Outcome Measure Information:
Title
fetal condition
Description
apgar score
Time Frame
5 minutes after cesarean section
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:pregnant patients full term elective cesarean section
-
Exclusion Criteria:
medical disorder with pregnancy
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
Learn more about this trial
Prostaglandins Before Caserean Section
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