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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Outcome; Bilateral Uterine Artery Ligation; Intrapartum or Postpartum Hemorrhage; Ovarian Reserve Markers
• Intervention / Treatment: Procedure: Bilateral uterine artery ligation

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Ahmed M.E. Ossman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; underwent normal cesarean section without Postpartum hemorrhage after delivery	Procedure: Bilateral uterine artery ligation; 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.
case group; cases underwent bilateral uterine artery ligation after Postpartum hemorrhage or Intrapartum hemorrhage after cesarean section.	Procedure: Bilateral uterine artery ligation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months after bilateral uterine artery ligation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	24 months after bilateral uterine artery ligation.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): October 31, 2022
• Study Completion (ACTUAL): October 31, 2022

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 4, 2022
• First Posted (ACTUAL): December 12, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 36034/11/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the data will be available when requested
• IPD Sharing Time Frame: Available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No