Dysfunctional Uterine Bleeding After Tubal Sterilization

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04396483

Collaborator

(none)

220

Enrollment

Locations

Arms

12.9

Anticipated Duration (Months)

110

Patients Per Site

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators will compare the frequency and amount of bleeding after tubal sterilization and salpingectomy

Condition or Disease	Intervention/Treatment	Phase
Contraception Dysfunctional Uterine Bleeding	Procedure: Pomeroy's tubal sterilization Procedure: Salpingectomy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Dysfunctional Uterine Bleeding After Tubal Sterilization and Salpingectomy

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tubal sterilization "Pomeroy's method"	Procedure: Pomeroy's tubal sterilization 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
Active Comparator: Salpingectomy	Procedure: Salpingectomy Both fallopian tubes will be completely removed during cesarean section

Arm

Intervention/Treatment

Experimental: Tubal sterilization "Pomeroy's method"

Procedure: Pomeroy's tubal sterilization

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

Active Comparator: Salpingectomy

Procedure: Salpingectomy

Both fallopian tubes will be completely removed during cesarean section

Outcome Measures

Primary Outcome Measures

Frequency of Dysfunctional bleeding [1 year after cesarean section]
percentage of cases suffering of dysfunctional bleeding
Amount of bleeding [1 year after cesarean section]
number of sanitary pads during bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adel Elgergawy	Tanta	Gharbia	Egypt	31111
2	Ayman Shehata Dawood	Tanta	Gharbia	Egypt	31111

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayman S Dawood, MD, Principal investigator, Tanta University

ClinicalTrials.gov Identifier:

NCT04396483

Other Study ID Numbers:

DUBATS

First Posted:

May 20, 2020

Last Update Posted:

Jun 16, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayman S Dawood, MD, Principal investigator, Tanta University

Dysfunctional uterine bleeding

Tubal sterilization

Salpingectomy

Cesarean section

Additional relevant MeSH terms:

Uterine Hemorrhage

Metrorrhagia

Hemorrhage

Study Results

No Results Posted as of Jun 16, 2021