Simplified Conservative Measures in Managing Morbidly Adherent Placenta in Beni-Suef University

NCT ID: NCT06465836

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-06-30

Brief Summary

To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.

Detailed Description

According to the International Federation of Gynecology and Obstetrics (FIGO) guidelines, the principal surgical strategy to prevent excessive bleeding related to placenta accreta syndrome is to leave the placenta in situ and perform a primary peripartum hysterectomy at delivery. A hysterectomy may not be preferred by patients wishing to preserve fertility and is detrimental to multiple aspects of the pelvic floor, bowel, and physical functions.

Surgical principles in placenta accreta syndrome include avoiding disruption of the hypervascular placenta, stepwise devascularization, early and comprehensive blood product transfusion, and judicious use of interventional radiologic techniques such as vascular embolization.

Conservative management describes any approach whereby hysterectomy is avoided

Conditions

Placenta Accreta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

O- lreay technique group

Group A: In which 86 patients will have bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly, two large vicryl stitches were passed using a large-sized needle below and lateral to the lower edge of the uterine incision angle in an anteroposterior direction and then redirected from back to the front through the avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly

Group Type: OTHER

O, lreay suture

Intervention Type: PROCEDURE

bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly two large vicryl stitches were passed using a large sized needle below and lateral to the lower edge of the uterine incision angle in anteroposterior direction and then redirected from back to the front through avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly

Modified O- lreay technique group

Group B: which will include 86 patients we will do our simplified approach which includes;

• After placental separation; try to grasp the lower segment or cervical flap.
• Close uterine cavity by continuous vicryl no 1 suture.
• Do 3 to 4 mattress sutures as the second layer of the uterus.
• Do uterine ligation with compression of the lower uterine segment (Modification of O, lreay suture) as demonstrated below:

1. Pack Douglas- pouch with a towel.

2. Straight the used vicryl needle mostly no 1.

3. Try to compress and approximate anterior and posterior uterine walls.

4. Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament.

Group Type: OTHER

modified O, lreay suture

Intervention Type: PROCEDURE

1. Pack Douglas- pouch with a towel.

2. Straight the used vicryl needle mostly no 1.

3. Try to compress and approximate anterior and posterior uterine walls.

4. Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament. And we repeat the procedure on the other side. We can repeat this method of uterine ligation at another different plane if needed.

Interventions

O, lreay suture

bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly two large vicryl stitches were passed using a large sized needle below and lateral to the lower edge of the uterine incision angle in anteroposterior direction and then redirected from back to the front through avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly

Intervention Type: PROCEDURE

modified O, lreay suture

1. Pack Douglas- pouch with a towel.

2. Straight the used vicryl needle mostly no 1.

3. Try to compress and approximate anterior and posterior uterine walls.

4. Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament. And we repeat the procedure on the other side. We can repeat this method of uterine ligation at another different plane if needed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Gestational age more than 28 weeks as determined by LMP and ultrasound.
• Placenta previa as confirmed by ultrasound.
• Clinically stable with no or mild vaginal bleeding.
• No evidence of fetal compromise.
• Patient consent.

Exclusion Criteria

• Vaginal bleeding
• Medical disorders

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nesreen Abdel Fattah Abdullah Shehata

OTHER

Sponsor Role: lead

Responsible Party

Nesreen Abdel Fattah Abdullah Shehata

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beni-Suef University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hamada Ali, A. professor

Role: CONTACT

hamadaashry@yahoo.com

0201007240754

nesreen shehata, professor

Role: CONTACT

nesoomar@yahoo.com

0201024150605

Other Identifiers

Morbidly adherent placenta

Identifier Type: -

Identifier Source: org_study_id