ContraceptionNCT04396483
Dysfunctional Uterine Bleeding After Tubal Sterilization
A study testing Pomeroy's tubal sterilization and Salpingectomy in people with Contraception and Dysfunctional Uterine Bleeding, run by Tanta University at 2 sites in Egypt.
Trial summary
In this study, the investigators will compare the frequency and amount of bleeding after tubal sterilization and salpingectomy Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Contraception, Dysfunctional Uterine Bleeding
- What is being tested?
- Pomeroy's tubal sterilization and Salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-40
- Patient completed her family
- Patient on cesarean delivery
Who cannot join
- Tubal sterilization by other methods
- Salpingectomy by laparoscopy
- Patient wishing fertility
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Adel Elgergawy
Tanta, Gharbia Governorate, 31111
Adel Elgergawy, MD, +201002057250, dradelali775@gmail.com
- Recruiting
Ayman Shehata Dawood
Tanta, Gharbia Governorate, 31111
Ayman Dawood, MD, +201020972067, ayman.dawood@med.tanta.edu.eg
About this study
Official title: 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
Read the 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
- Conditions
- Contraception, Dysfunctional Uterine Bleeding
- Being tested
- Pomeroy's tubal sterilization, Salpingectomy
- Keywords
- Dysfunctional uterine bleeding, Tubal sterilization, Salpingectomy, Cesarean section
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomeroy's tubal sterilizationProcedure or surgery
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
SalpingectomyProcedure or surgery
Both fallopian tubes will be completely removed during cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Tubal sterilization "Pomeroy's method" | Experimental | Not described Receives: Procedure: Pomeroy's tubal sterilization |
| Salpingectomy | Active comparator | Not described Receives: Procedure: Salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Dysfunctional bleeding
percentage of cases suffering of dysfunctional bleeding
Measured: 1 year after cesarean section
Amount of bleeding
number of sanitary pads during bleeding
Measured: 1 year after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jun 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396483
- Sponsor's protocol ID
- DUBATS
- Status last verified
- Nov 2023
- First submitted
- 15 May 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When valid request is present
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysfunctional Uterine Bleeding After Tubal Sterilization and Salpingectomy
- ClinicalTrials.gov ID
- NCT04396483
- Acronym / sponsor ID
- DUBATS
- Conditions
- Contraception, Dysfunctional Uterine Bleeding
- Keywords
- Dysfunctional uterine bleeding, Tubal sterilization, Salpingectomy, Cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubal sterilization "Pomeroy's method" | Experimental | Procedure: Pomeroy's tubal sterilization |
| Salpingectomy | Active comparator | Procedure: Salpingectomy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-40
- Patient completed her family
- Patient on cesarean delivery
Key exclusion criteria (3 listed)
- Tubal sterilization by other methods
- Salpingectomy by laparoscopy
- Patient wishing fertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomeroy's tubal sterilizationBoth 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 | Procedure or surgery | Tubal sterilization "Pomeroy's method" |
| SalpingectomyBoth fallopian tubes will be completely removed during cesarean section | Procedure or surgery | Salpingectomy |
Primary outcome
Frequency of Dysfunctional bleeding
Time frame: 1 year after cesarean section
percentage of cases suffering of dysfunctional bleeding
Amount of bleeding
Time frame: 1 year after cesarean section
number of sanitary pads during bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Yes. When valid request is present
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomeroy's tubal sterilization and Salpingectomy in people with Contraception and Dysfunctional Uterine Bleeding, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Dysfunctional bleeding (time frame: 1 year after cesarean section). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.