Skip to main content
OpenTrials
Completed

NCT Number: NCT05584995

Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed M.E. Ossman

Tanta, El-Gharbia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Control Group

Procedure

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

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.

Primary outcomes

  1. Color Doppler parameters

    Time frame: After Bilateral Uterine Artery Ligation

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

Secondary outcomes

  1. The uterine artery's descending branches

    Time frame: 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.

  2. The uterine artery's ascending branch

    Time frame: 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.

  3. Color Doppler parameters

    Time frame: After Bilateral Uterine Artery Ligation

    resistance Index (RI) will be recorded

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 18, 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.

Published trials that share one or more normalized conditions with this study.