Placenta Accreta
Conditions
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
Interventions
PROCEDUREO, 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
PROCEDUREmodified O, lreay suture
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.
Sponsors
Nesreen Abdel Fattah Abdullah Shehata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization will be done by online research randomizer as follows (https://www.randomizer.org/about/ ): 2 Sets of 86 Unique Numbers Per Set Range: From 1 to 172
Intervention model description
Patients will be randomized into two groups. One of two intraoperative surgical interventions that will be evolved during the study period: Group A: In which 86 patients will have bilateral uterine artery ligations as described by the O- lreay technique in addition to standard conservative methods. The stitches were tied securely anteriorly. Group B: which will include 86 patients we will do our simplified approach which include; * After placental separation; try to grasp 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).
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Maternal mortality | 24 hours postoperatively | Maternal death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gynecological conditions | 6 months | Gynecological complications as amenorrhea, intrauterine adhesions and niche formation. |
Countries
Egypt
Contacts
Primary ContactHamada Ali, A. professor
Backup Contactnesreen shehata, professor
Outcome results
None listed