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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465836
• Other study ID #: Morbidly adherent placenta
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Beni-Suef University
• Contact: Hamada Ali, A. professor
• Phone: 0201007240754
• Email: hamadaashry[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nesreen Abdel Fattah Abdullah Shehata

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gynecological conditions	Gynecological complications as amenorrhea, intrauterine adhesions and niche formation.	6 months
Primary	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	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
Secondary	Maternal mortality	Maternal death	24 hours postoperatively