Bilateral Uterine Artery LigationNCT05647538
Bilateral Uterine Artery Ligation After Intrapartum or Postpartum Hemorrhage on Ovarian Reserve Markers and Pregnancy Outcome
An observational study of Bilateral Uterine Artery Ligation and Intrapartum or Postpartum Hemorrhage, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the possible negative effects of uterine artery ligation on ovarian reserve markers and subsequent pregnancy outcomes Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Bilateral Uterine Artery Ligation, Intrapartum or Postpartum Hemorrhage, Ovarian Reserve Markers
- What is being tested?
- Bilateral uterine artery ligation
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 31 Oct 2022
- Phase
- Observational
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients will be classified into two equal groups control group: underwent normal cesarean section without Postpartum hemorrhage, case group: cases underwent bilateral uterine artery ligation after Postpartum hemorrhage or intrapartum hemorrhage after cesarean section. All patients will be subjected to the following clinical parameters assessment (age, cycle history, body mass index, parity, preceding treatment and/or surgery menstruation characteristics (quantity of menstruation and dysmenorrhoea) and endometrial biopsy.
Who may be able to join
- 120 females aged from 20 to 35 years old
- with Postpartum hemorrhage or intrapartum hemorrhage after cesarean section
- did not respond to medical therapy
- performed successful bilateral uterine artery ligation for hemorrhage management.
Who cannot join
- The presence of male factor or tubal factor.
- Hypertension, autoimmune disease, morbid obesity, absence of lactation diabetes millets, vascular disease, smoking or the use of alcohol.
- The presence of additional surgery or medical disease.
- Detection of a uterine anomaly, history of intrauterine growth restriction in previous pregnancies.
- Usage of a hormonal therapy through the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bilateral Uterine Artery Ligation After Intrapartum or Postpartum Hemorrhage on Ovarian Reserve Markers and Pregnancy Outcome
The aim of this study is to assess the possible negative effects of uterine artery ligation on ovarian reserve markers and subsequent pregnancy outcomes
Read the detailed description
One of the most common surgical methods for preserving fertility is uterine artery ligation. It is simple to do and effective at reducing Postpartum hemorrhage after delivery . Additionally, it is rather safe and permits future childbearing for the patients.
- Conditions
- Bilateral Uterine Artery Ligation, Intrapartum or Postpartum Hemorrhage, Ovarian Reserve Markers, Pregnancy Outcome
- Being tested
- Bilateral uterine artery ligation
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral uterine artery ligationProcedure or surgery
Bilateral UAL was done 2 cm under the Kerr incision (lower segment transverse). A 2-Vicryl absorbable suture (Ethicon, Neuilly-surSeine, France) was introduced from the anterior to posterior views of the myometrium 2-3 cm medial to the descending part of the uterine vessels within an avascular area in the broad ligament and tied. Following the surgery, the uterine tone and hemorrhage were managed.
| Study group | Role | What they receive |
|---|---|---|
| control group | underwent normal cesarean section without Postpartum hemorrhage after delivery Receives: Procedure: Bilateral uterine artery ligation | |
| case group | cases underwent bilateral uterine artery ligation after Postpartum hemorrhage or Intrapartum hemorrhage after cesarean section. Receives: Procedure: Bilateral uterine artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve by anti-mullerian hormone
Anti-mullerian hormone (AMH) level will be determined using a two-sided immunoassay that will be enzymatically amplified (ELISA). AMH was recorded at 6, 12 and 24 months after bilateral uterine artery ligation.
Measured: 24 months after bilateral uterine artery ligation.
Secondary outcomes (3)
Ovarian reserve by follicle stimulating hormone
follicle stimulating hormone (FSH) level will be determined using a two-sided immunoassay that will be enzymatically amplified (ELISA). FSH was recorded at 6, 12 and 24 months after bilateral uterine artery ligation.
Measured: 24 months after bilateral uterine artery ligation.
Ovarian reserve by antral follicle counts
antral follicle counts were recorded at 6, 12 and 24 months after bilateral uterine artery ligation.
Measured: 24 months after bilateral uterine artery ligation.
Percent of subsequent pregnancy cases
patients were asked about their desire for pregnancy in the future The data of subsequent pregnancy cases following bilateral UAL primary were recorded and follow-up was done at 6, 12 and 24 months after BUAL.
Measured: 24 months after bilateral uterine artery ligation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jun 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Uterine Artery LigationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ossman, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647538
- Sponsor's protocol ID
- 36034/11/22
- Status last verified
- Feb 2023
- First submitted
- 4 Dec 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be available when requested
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Uterine Artery Ligation After Intrapartum or Postpartum Hemorrhage on Ovarian Reserve Markers and Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT05647538
- Acronym / sponsor ID
- 36034/11/22
- Conditions
- Bilateral Uterine Artery Ligation, Intrapartum or Postpartum Hemorrhage, Ovarian Reserve Markers, Pregnancy Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Dec 2022 (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.
The aim of this study is to assess the possible negative effects of uterine artery ligation on ovarian reserve markers and subsequent pregnancy outcomes
Detailed description
One of the most common surgical methods for preserving fertility is uterine artery ligation. It is simple to do and effective at reducing Postpartum hemorrhage after delivery . Additionally, it is rather safe and permits future childbearing for the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Procedure: Bilateral uterine artery ligationunderwent normal cesarean section without Postpartum hemorrhage after delivery |
| case group | – | Procedure: Bilateral uterine artery ligationcases underwent bilateral uterine artery ligation after Postpartum hemorrhage or Intrapartum hemorrhage after cesarean section. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be classified into two equal groups control group: underwent normal cesarean section without Postpartum hemorrhage, case group: cases underwent bilateral uterine artery ligation after Postpartum hemorrhage or intrapartum hemorrhage after cesarean section. All patients will be subjected to the following clinical parameters assessment (age, cycle history, body mass index, parity, preceding treatment and/or surgery menstruation characteristics (quantity of menstruation and dysmenorrhoea) and endometrial biopsy.
Key inclusion criteria (4 listed)
- 120 females aged from 20 to 35 years old
- with Postpartum hemorrhage or intrapartum hemorrhage after cesarean section
- did not respond to medical therapy
- performed successful bilateral uterine artery ligation for hemorrhage management.
Key exclusion criteria (5 listed)
- The presence of male factor or tubal factor.
- Hypertension, autoimmune disease, morbid obesity, absence of lactation diabetes millets, vascular disease, smoking or the use of alcohol.
- The presence of additional surgery or medical disease.
- Detection of a uterine anomaly, history of intrauterine growth restriction in previous pregnancies.
- Usage of a hormonal therapy through the research.
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 |
|---|---|---|
| Bilateral uterine artery ligationBilateral UAL was done 2 cm under the Kerr incision (lower segment transverse). A 2-Vicryl absorbable suture (Ethicon, Neuilly-surSeine, France) was introduced from the anterior to posterior views of the myometrium 2-3 cm medial to the descending part of the uterine vessels within an avascular area in the broad ligament and tied. Following the surgery, the uterine tone and hemorrhage were managed. | Procedure or surgery | case group, control group |
Primary outcome
Ovarian reserve by anti-mullerian hormone
Time frame: 24 months after bilateral uterine artery ligation.
Anti-mullerian hormone (AMH) level will be determined using a two-sided immunoassay that will be enzymatically amplified (ELISA). AMH was recorded at 6, 12 and 24 months after bilateral uterine artery ligation.
3 secondary outcomes
Ovarian reserve by follicle stimulating hormone
Time frame: 24 months after bilateral uterine artery ligation.
Ovarian reserve by antral follicle counts
Time frame: 24 months after bilateral uterine artery ligation.
Percent of subsequent pregnancy cases
Time frame: 24 months after bilateral uterine artery ligation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: Yes. the data will be available when requested
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Uterine Artery Ligation and Intrapartum or Postpartum Hemorrhage, run by Tanta University at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian reserve by anti-mullerian hormone (time frame: 24 months after bilateral uterine artery ligation.). 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 9 Feb 2023.