Dysfunctional Uterine Bleeding After Tubal Sterilization

NCT ID: NCT04396483

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Contraception Dysfunctional Uterine Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tubal sterilization "Pomeroy's method"

Group Type EXPERIMENTAL

Pomeroy's tubal sterilization

Intervention Type PROCEDURE

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

Salpingectomy

Group Type ACTIVE_COMPARATOR

Salpingectomy

Intervention Type PROCEDURE

Both fallopian tubes will be completely removed during cesarean section

Interventions

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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

Intervention Type PROCEDURE

Salpingectomy

Both fallopian tubes will be completely removed during cesarean section

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ayman S Dawood, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adel Elgergawy

Tanta, Gharbia Governorate, Egypt

Site Status RECRUITING

Ayman Shehata Dawood

Tanta, Gharbia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Adel Elgergawy, MD

Role: primary

+201002057250

Ayman Dawood, MD

Role: primary

+201020972067

Other Identifiers

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DUBATS

Identifier Type: -

Identifier Source: org_study_id