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

Beni-Suef University Hospital Simplified Conservative Approach for Managing Placenta Accreta Spectrum: RCT

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.

Study Overview

• Status: Recruiting
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: O, lreay suture; Procedure: modified O, lreay suture

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

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamada Ali, A. professor; Phone Number: 0201007240754; Email: hamadaashry@yahoo.com
• Study Contact Backup: Name: nesreen shehata, professor; Phone Number: 0201024150605; Email: nesoomar@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Beni-Suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Procedure: 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
Other: 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:Pack Douglas- pouch with a towel.Straight the used vicryl needle mostly no 1.Try to compress and approximate anterior and posterior uterine walls.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; Pack Douglas- pouch with a towel.; Straight the used vicryl needle mostly no 1.; Try to compress and approximate anterior and posterior uterine walls.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal morbidity	Coagulopathy, need for massive blood transfusion (> 4 units), length of hospital stay, and visceral injuries ICU admission and post-operative pain.	24 hours post operatively
Maternal mortality	Maternal death	24 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gynecological conditions	Gynecological complications as amenorrhea, intrauterine adhesions and niche formation.	6 months

Collaborators and Investigators

• Sponsor: Nesreen Abdel Fattah Abdullah Shehata

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Accreta
• Other Study ID Numbers: Morbidly adherent placenta

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No