Dysfunctional Uterine Bleeding After Tubal Sterilization

November 23, 2023 updated by: Ayman S Dawood, MD, Tanta University

Dysfunctional Uterine Bleeding After Tubal Sterilization and Salpingectomy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 31111
        • Recruiting
        • Adel Elgergawy
        • Contact:
      • Tanta, Gharbia, Egypt, 31111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Dysfunctional bleeding
Time Frame: 1 year after cesarean section
percentage of cases suffering of dysfunctional bleeding
1 year after cesarean section
Amount of bleeding
Time Frame: 1 year after cesarean section
number of sanitary pads during bleeding
1 year after cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUBATS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When valid request is present

IPD Sharing Time Frame

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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