An interventional study of O, lreay suture and modified O, lreay suture in Placenta Accreta, sponsored by Nesreen Abdel Fattah Abdullah Shehata. Recruiting at 1 site in Egypt. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Nesreen Abdel Fattah Abdullah Shehata · Not applicable, Interventional, and Treatment
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.
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
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 172 is above the median of 70 across 67 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Nesreen Abdel Fattah Abdullah Shehata is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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.
Amount of blood loss
The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.
Time frame: 6 hours postoperatively
Maternal morbidity
Coagulopathy, need for massive blood transfusion (\> 4 units), length of hospital stay, and visceral injuries ICU admission and post-operative pain.
Time frame: 24 hours post operatively
Maternal mortality
Maternal death
Time frame: 24 hours postoperatively
Gynecological conditions
Gynecological complications as amenorrhea, intrauterine adhesions and niche formation.
Time frame: 6 months
Started Mar 2024 (actual). Primary completion is estimated for Jun 2025, 15 months after the start.
Of 45 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 15 months is below that.
Counting every sponsor, half of 45 studies reached it within 19 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nesreen Abdel Fattah Abdullah Shehata