Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage; Color Doppler; Ligation; Uterine Artery
• Interventions: Procedure: Control group; Procedure: BUAL group

• Registration Number: NCT05584995
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Obstetric haemorrhage is the main reason of maternal death in both countries with high and poor incomes. Most of these deaths occurred within the first 24 hours following birth. Placenta accrete, retained placenta, genital tract lacerations, uterine rupture, and coagulation abnormalities are established risk factors for postpartum hemorrhage. The management of Idiopathic pulmonary hemosiderosis (IPH) and postpartum hemorrhage relies on numerous considerations: type of delivery (vaginal or caesarean delivery), bleeding etiology (uterine atony, trauma, retained placenta) and hemodynamic stability.

In the first stage, early identification, and treatment with uterotonics, suturing the lacerations, and fundal massage are crucial. When bleeding persist, even in the aggressive medical treatment, suitable surgical intervention should be performed.

Surgical therapy relies on the patient's desire to maintain fertility, the severity of the bleeding, and the surgeon's experience.

Historically, peripartum hysterectomy was the only available management to prevent postpartum hemorrhage but, in some instances, hysterectomy alone is insufficient to control the bleeding.

Also, the desire to preserve fertility have resulted in the development of other techniques, such as pelvic embolization and internal iliac artery ligation (IIAL)and bilateral uterine artery ligation (BUAL).

Bilateral uterine artery ligation (BUAL) is the most popular surgical procedure for quick management of postpartum hemorrhage. It may be performed alone or with conjugation with other postpartum hemorrhage methods in with success rate exceeds 90 %. Recanalization is a natural process that may occur following vascular structure closure with a suture or radiological embolization.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2022-08-20
• Study Completion: 2022-08-20
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• 70 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Women will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)
BUAL group	BUAL group	Cases will undergo Bilateral Uterine Artery Ligationafter Postpartum Hemorrhage after cesarean section resistant to medical treatment and did not need a hysterectomy.

Primary Outcome Measures

Name	Time	Method
Color Doppler parameters	After Bilateral Uterine Artery Ligation	Color Doppler parameters for measuring the UtA diameters as UtA pulsatility Index will be recorded

Secondary Outcome Measures

Name	Time	Method
The uterine artery's descending branches	After Bilateral Uterine Artery Ligation	The uterine artery's descending branches will be measured at the level of the internal os of the uterine cervix.
The uterine artery's ascending branch	After Bilateral Uterine Artery Ligation	The uterine artery's ascending branch on the left and right sides of the uterine isthmus will be identified by means of color flow imaging to obtain uterine arterial blood flow velocity waveforms.
Color Doppler parameters	After Bilateral Uterine Artery Ligation	resistance Index (RI) will be recorded

Trial Locations

Locations (1)

Ahmed M.E. Ossman; 🇪🇬 Tanta, El-Gharbia Governorate, Egypt