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

Not Applicable

Recruiting

• Conditions: Placenta Accreta

• Registration Number: NCT06465836
• Lead Sponsor: Nesreen Abdel Fattah Abdullah Shehata

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

Study Timeline

• Study Start: 2024-03-15
• Study First Submitted: 2024-05-12
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of blood loss	6 hours postoperatively	The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beni-Suef University; 🇪🇬 Cairo, Egypt