Simplified Conservative Measures in Managing Morbidly Adherent Placenta in Beni-Suef University
- Conditions
- Placenta Accreta
- Interventions
- Procedure: O, lreay sutureProcedure: modified O, lreay suture
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 172
- 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.
- Vaginal bleeding
- Medical disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description O- lreay technique group O, lreay suture 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 Modified O- lreay technique group modified O, lreay suture 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.
- 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