Uterine Artery Color Doppler Parameters After Bilateral Uterine Artery Ligation

NCT ID: NCT05584995

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-08-20

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.

Conditions

Postpartum Hemorrhage; Ligation; Color Doppler; Uterine Artery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: EXPERIMENTAL

Control group

Intervention Type: PROCEDURE

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

BUAL group

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

Group Type: EXPERIMENTAL

BUAL group

Intervention Type: 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.

Interventions

Control group

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ossman

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed M.E. Ossman

Tanta, El-Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

35873/9/22

Identifier Type: -

Identifier Source: org_study_id