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Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

Primary Purpose

Postpartum Hemorrhage, Ligation, Color Doppler

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Control group
BUAL group
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ahmed M.E. Ossman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group

BUAL group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Color Doppler parameters
resistance Index (RI) will be recorded

Full Information

First Posted
October 11, 2022
Last Updated
February 7, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05584995
Brief Title
Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation
Official Title
Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation for Postpartum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Ligation, Color Doppler, Uterine Artery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
Women will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)
Arm Title
BUAL group
Arm Type
Experimental
Arm Description
Cases will undergo Bilateral Uterine Artery Ligationafter Postpartum Hemorrhage after cesarean section resistant to medical treatment and did not need a hysterectomy.
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
Women will undergo normal cesarean section without Postpartum Hemorrhage or Idiopathic pulmonary hemosiderosis (IPH)
Intervention Type
Procedure
Intervention Name(s)
BUAL group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Color Doppler parameters
Description
Color Doppler parameters for measuring the UtA diameters as UtA pulsatility Index will be recorded
Time Frame
After Bilateral Uterine Artery Ligation
Secondary Outcome Measure Information:
Title
The uterine artery's descending branches
Description
The uterine artery's descending branches will be measured at the level of the internal os of the uterine cervix.
Time Frame
After Bilateral Uterine Artery Ligation
Title
The uterine artery's ascending branch
Description
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.
Time Frame
After Bilateral Uterine Artery Ligation
Title
Color Doppler parameters
Description
resistance Index (RI) will be recorded
Time Frame
After Bilateral Uterine Artery Ligation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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)
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ahmed M.E. Ossman
City
Tanta
State/Province
El-Gharbia Governorate
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

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