Bilateral Uterine Artery Ligation After Intrapartum or Postpartum Hemorrhage on Ovarian Reserve Markers and Pregnancy Outcome

Completed

• Conditions: Bilateral Uterine Artery Ligation; Intrapartum or Postpartum Hemorrhage; Ovarian Reserve Markers; Pregnancy Outcome
• Interventions: Procedure: Bilateral uterine artery ligation

• Registration Number: NCT05647538
• Lead Sponsor: Tanta University

Brief 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

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 Timeline

• Study Start: 2020-06-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Study First Submitted: 2022-12-04
• Study First Submitted QC: 2022-12-04
• Study First Posted: 2022-12-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case group	Bilateral uterine artery ligation	cases underwent bilateral uterine artery ligation after Postpartum hemorrhage or Intrapartum hemorrhage after cesarean section.
control group	Bilateral uterine artery ligation	underwent normal cesarean section without Postpartum hemorrhage after delivery

Primary Outcome Measures

Name	Time	Method
Ovarian reserve by anti-mullerian hormone	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.

Secondary Outcome Measures

Name	Time	Method
Percent of subsequent pregnancy cases	24 months after bilateral uterine artery ligation.	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.
Ovarian reserve by antral follicle counts	24 months after bilateral uterine artery ligation.	antral follicle counts were recorded at 6, 12 and 24 months after bilateral uterine artery ligation.
Ovarian reserve by follicle stimulating hormone	24 months after bilateral uterine artery ligation.	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.

Trial Locations

Locations (1)

Ahmed M.E. Ossman; 🇪🇬 Tanta, Egypt