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

NCT05647538 | Completed

• 1 other identifier: 36034/11/22
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Bilateral Uterine Artery Ligation; Intrapartum or Postpartum Hemorrhage; Ovarian Reserve Markers; Pregnancy Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ovarian reserve by follicle stimulating hormone

  24 months after bilateral uterine artery ligation.

• Ovarian reserve by antral follicle counts

  24 months after bilateral uterine artery ligation.

• Percent of subsequent pregnancy cases

  24 months after bilateral uterine artery ligation.

Study Arms (2)

control group

underwent normal cesarean section without Postpartum hemorrhage after delivery

Procedure: Bilateral uterine artery ligation

case group

cases underwent bilateral uterine artery ligation after Postpartum hemorrhage or Intrapartum hemorrhage after cesarean section.

Procedure: Bilateral uterine artery ligation

Interventions

Bilateral uterine artery ligation PROCEDURE

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; control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: females aged from 20 to 35 years old with Postpartum hemorrhage or intrapartum hemorrhage after cesarean section who did not respond to medical therapy and performed successful bilateral uterine artery ligation for hemorrhage management.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ahmed M.E. Ossman

Tanta, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology Department Tanta, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 12, 2022
• Study Start: June 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available

Locations

EG (1)