Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation for Postpartum Hemorrhage

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

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage; Ligation; Color Doppler; Uterine Artery
• Intervention / Treatment: Procedure: Control group; Procedure: BUAL group

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia Governorate
    • Tanta, El-Gharbia Governorate, Egypt
      • Ahmed M.E. Ossman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Control group; Women will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)	Procedure: Control group; Women will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)
EXPERIMENTAL: BUAL group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color Doppler parameters	Color Doppler parameters for measuring the UtA diameters as UtA pulsatility Index will be recorded	After Bilateral Uterine Artery Ligation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The uterine artery's descending branches	The uterine artery's descending branches will be measured at the level of the internal os of the uterine cervix.	After Bilateral Uterine Artery Ligation
The uterine artery's ascending branch	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.	After Bilateral Uterine Artery Ligation
Color Doppler parameters	resistance Index (RI) will be recorded	After Bilateral Uterine Artery Ligation

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): August 20, 2022
• Study Completion (ACTUAL): August 20, 2022

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (ACTUAL): October 18, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 35873/9/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available under a reasonable request from the corresponding author.
• IPD Sharing Time Frame: One year after the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No