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Completed

NCT Number: NCT05647538

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

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Key information

Conditions

Bilateral Uterine Artery Ligation Female Urogenital Diseases and Pregnancy Complications Hemorrhage Intrapartum or Postpartum Hemorrhage Obstetric Labor Complications Ovarian Reserve Markers Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Pregnancy Outcome Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Ahmed M.E. Ossman

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ovarian reserve by follicle stimulating hormone

    Time frame: 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.

  2. Ovarian reserve by antral follicle counts

    Time frame: 24 months after bilateral uterine artery ligation.

    antral follicle counts were recorded at 6, 12 and 24 months after bilateral uterine artery ligation.

  3. Percent of subsequent pregnancy cases

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2022
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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