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

Pregnancy Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05647538
• Other study ID #: 36034/11/22
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Pregnancy Outcome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed M.E. Ossman	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.