Back to resultsRole of Drain in Decreasing Postoperative Complications
Primary Purpose
Cesarean Section Complications
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Drain insertion
Sponsored by
About this trial
This is an interventional other trial for Cesarean Section Complications
Eligibility Criteria
Inclusion Criteria:
Women undergoing cesarean section
Exclusion Criteria:
- Women who deliver by normal vaginal delivery
Sites / Locations
- Algazeerah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Drain
No drain
Arm Description
Outcomes
Primary Outcome Measures
The number of women who will have complications
How many women who will have complications postoperative
Secondary Outcome Measures
Full Information
NCT ID
NCT04287933
First Posted
February 26, 2020
Last Updated
February 26, 2020
Sponsor
Aljazeera Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04287933
Brief Title
Role of Drain in Decreasing Postoperative Complications
Official Title
Role of Drain in Decreasing Postoperative Complications After Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Anticipated)
Primary Completion Date
July 3, 2020 (Anticipated)
Study Completion Date
August 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
postoperative complications are common after cesarean section
Detailed Description
wound infection can occur after cesarean section
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drain
Arm Type
Active Comparator
Arm Title
No drain
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Drain insertion
Intervention Description
insertion of a drain
Primary Outcome Measure Information:
Title
The number of women who will have complications
Description
How many women who will have complications postoperative
Time Frame
within 2 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women who will have complications after cesarean sectin
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women undergoing cesarean section
Exclusion Criteria:
Women who deliver by normal vaginal delivery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy, PhD
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
Algezeera hospitaland National Research Centre ,Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Algazeerah
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
12. IPD Sharing Statement
Learn more about this trial
Role of Drain in Decreasing Postoperative Complications
We'll reach out to this number within 24 hrs