Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

NCT05584995 | Completed

• 1 other identifier: 35873/9/22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess Uterine artery color doppler parameters after bilateral uterine artery ligation (BUAL) for Postpartum Hemorrhage.

Conditions

Postpartum Hemorrhage; Ligation; Color Doppler; Uterine Artery

Outcome Measures

Primary Outcomes (1)

• Color Doppler parameters

  Color Doppler parameters for measuring the UtA diameters as UtA pulsatility Index will be recorded

  After Bilateral Uterine Artery Ligation

Secondary Outcomes (3)

• The uterine artery's descending branches

  After Bilateral Uterine Artery Ligation

• The uterine artery's ascending branch

  After Bilateral Uterine Artery Ligation

• Color Doppler parameters

  After Bilateral Uterine Artery Ligation

Study Arms (2)

Control group

EXPERIMENTAL

Women will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)

Procedure: Control group

BUAL group

EXPERIMENTAL

Cases will undergo Bilateral Uterine Artery Ligationafter Postpartum Hemorrhage after cesarean section resistant to medical treatment and did not need a hysterectomy.

Procedure: BUAL group

Interventions

Control group PROCEDURE

Women will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)

Control group

BUAL group PROCEDURE

Bilateral Uterine Artery Ligation Technique: All uterine surgeries will be conducted by externalizing the uterus as much as possible and holding it by the fundus. The BUAL will be done using absorbable suture no. 1 Vicryl (Vicryl 1, Ethicon, France, Neuvilly-sur-Seine, France) will be placed through an avascular space in the broad ligament and tied from the anterior to posterior aspects of the myometrium 2-3 cm medial to the descending portion of the uterine vessels. In all patients, the suture will be carried from the anterior to the posterior at 1 cm to the myometrium medial to the Uterine artery and will be knotted after passing it through the avascular region at 1 cm to the wide ligament section adjacent to the uterus in both sides. All patients will be examined for uterotonics during and after the surgery. The ovarian arteries will be assessed at the level of the ovarian hilum.

BUAL group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: 70 women aged between 20 and 35 years old. Cases underwent Bilateral Uterine Artery Ligation after Postpartum Hemorrhageafter cesarean section, resistant to medical treatment, and did not need to hysterectomy. The Control group will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women aged between 20 and 35 years old.
• Undergoing Bilateral Uterine Artery Ligation after Postpartum Hemorrhageafter cesarean section
• resistant to medical treatment, and did not need to hysterectomy.

You may not qualify if:

• Patients with male factor, tubal factor, and absence of lactation.
• Diabetes mellitus, hypertension, morbid obesity, autoimmune disease, or vascular disease in the history, smoking.
• Intrauterine growth restriction in previous pregnancies history, detection of a uterine anomaly or a medical condition, as well as administration of a hormonal treatment during the study.
• Uncontrolled bleeding is needed for a hysterectomy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ahmed M.E. Ossman

Tanta, El-Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 18, 2022
• Study Start: August 1, 2020
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)