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

NCT06465836 | Recruiting DMC

• 1 other identifier: Morbidly adherent placenta
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• Amount of blood loss

  The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.

  6 hours postoperatively

Secondary Outcomes (2)

• Maternal morbidity

  24 hours post operatively

• Maternal mortality

  24 hours postoperatively

Other Outcomes (1)

• Gynecological conditions

  6 months

Study Arms (2)

O- lreay technique group

OTHER

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

Procedure: O, lreay suture

Modified O- lreay technique group

OTHER

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.

Procedure: modified O, lreay suture

Interventions

O, lreay suture 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

O- lreay technique group

modified O, lreay suture 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.

Modified O- lreay technique group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Vaginal bleeding
• Medical disorders

Sponsors & Collaborators

• Nesreen Abdel Fattah Abdullah Shehata: lead

Study Sites (1)

Beni-Suef University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Central Study Contacts

Hamada Ali, A. professor

CONTACT

0201007240754; hamadaashry@yahoo.com

nesreen shehata, professor

CONTACT

0201024150605; nesoomar@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by online research randomizer as follows (https://www.randomizer.org/about/ ): 2 Sets of 86 Unique Numbers Per Set Range: From 1 to 172
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized into two groups. One of two intraoperative surgical interventions that will be evolved during the study period: Group A: In which 86 patients will have bilateral uterine artery ligations as described by the O- lreay technique in addition to standard conservative methods. The stitches were tied securely anteriorly. Group B: which will include 86 patients we will do our simplified approach which include; * After placental separation; try to grasp 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).

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: June 20, 2024
• Study Start: March 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

EG (1)