Back to resultsDysfunctional Uterine Bleeding After Tubal Sterilization
Primary Purpose
Contraception, Dysfunctional Uterine Bleeding
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pomeroy's tubal sterilization
Salpingectomy
Sponsored by
About this trial
This is an interventional basic science trial for Contraception focused on measuring Dysfunctional uterine bleeding, Tubal sterilization, Salpingectomy, Cesarean section
Eligibility Criteria
Inclusion Criteria:
- Age 20-40
- Patient completed her family
- Patient on cesarean delivery
Exclusion Criteria:
- Tubal sterilization by other methods
- Salpingectomy by laparoscopy
- Patient wishing fertility
Sites / Locations
- Adel ElgergawyRecruiting
- Ayman Shehata DawoodRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tubal sterilization "Pomeroy's method"
Salpingectomy
Arm Description
Outcomes
Primary Outcome Measures
Frequency of Dysfunctional bleeding
percentage of cases suffering of dysfunctional bleeding
Amount of bleeding
number of sanitary pads during bleeding
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04396483
Brief Title
Dysfunctional Uterine Bleeding After Tubal Sterilization
Official Title
Dysfunctional Uterine Bleeding After Tubal Sterilization and Salpingectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigators will compare the frequency and amount of bleeding after tubal sterilization and salpingectomy
Detailed Description
Dysfunctional uterine bleeding is common after tubal sterilization.
The investigators will compare the frequency and amount of bleeding after two techniques eithe tubal sterilization by pomeroy's method during cesarean section or complete salpingectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Dysfunctional Uterine Bleeding
Keywords
Dysfunctional uterine bleeding, Tubal sterilization, Salpingectomy, Cesarean section
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tubal sterilization "Pomeroy's method"
Arm Type
Experimental
Arm Title
Salpingectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Pomeroy's tubal sterilization
Intervention Description
Both Fallopian tubes will be grasped by allis forceps and a kokher forceps will be applied below the allis forceps then excision of tubal part above kokher and transfixation of both ends away from each other during cesarean section
Intervention Type
Procedure
Intervention Name(s)
Salpingectomy
Intervention Description
Both fallopian tubes will be completely removed during cesarean section
Primary Outcome Measure Information:
Title
Frequency of Dysfunctional bleeding
Description
percentage of cases suffering of dysfunctional bleeding
Time Frame
1 year after cesarean section
Title
Amount of bleeding
Description
number of sanitary pads during bleeding
Time Frame
1 year 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:
Age 20-40
Patient completed her family
Patient on cesarean delivery
Exclusion Criteria:
Tubal sterilization by other methods
Salpingectomy by laparoscopy
Patient wishing fertility
Facility Information:
Facility Name
Adel Elgergawy
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adel Elgergawy, MD
Phone
+201002057250
Email
dradelali775@gmail.com
Facility Name
Ayman Shehata Dawood
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayman Dawood, MD
Phone
+201020972067
Email
ayman.dawood@med.tanta.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
When valid request is present
IPD Sharing Time Frame
6 months
Learn more about this trial
Dysfunctional Uterine Bleeding After Tubal Sterilization
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