NCT04396483

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

May 15, 2020

Last Update Submit

November 23, 2023

Conditions

ContraceptionDysfunctional Uterine Bleeding

Keywords

Dysfunctional uterine bleedingTubal sterilizationSalpingectomyCesarean section

Outcome Measures

Primary Outcomes (2)

  • Frequency of Dysfunctional bleeding

    percentage of cases suffering of dysfunctional bleeding

    1 year after cesarean section

  • Amount of bleeding

    number of sanitary pads during bleeding

    1 year after cesarean section

Study Arms (2)

Tubal sterilization "Pomeroy's method"

EXPERIMENTAL
Procedure: Pomeroy's tubal sterilization

Salpingectomy

ACTIVE COMPARATOR
Procedure: Salpingectomy

Interventions

Pomeroy's tubal sterilizationPROCEDURE

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

Tubal sterilization "Pomeroy's method"
SalpingectomyPROCEDURE

Both fallopian tubes will be completely removed during cesarean section

Salpingectomy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-40
  • Patient completed her family
  • Patient on cesarean delivery

You may not qualify if:

  • Tubal sterilization by other methods
  • Salpingectomy by laparoscopy
  • Patient wishing fertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adel Elgergawy

Tanta, Gharbia Governorate, 31111, Egypt

RECRUITING

Ayman Shehata Dawood

Tanta, Gharbia Governorate, 31111, Egypt

RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Interventions

Salpingectomy

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 20, 2020

Study Start

June 1, 2021

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

When valid request is present

Shared Documents
STUDY PROTOCOL
Time Frame
6 months

Locations

EG(2)