DUGi

Intentional retention of placenta versus Triple P technique for conservative management of placenta accreta spectrum: a multicentre, controlled, open-label, randomised clinical trial

http://dugi.udg.edu/item/http:@@@@hdl.handle.net@@10256@@23045

Background: Placenta accreta spectrum (PAS) is a pathologic condition of placentation in which trophoblastic tissue adheres or invades the uterine wall beyond the uterine decidua basalis layer. PAS disorders have become a significant life-threatening obstetrical issue due to its increased incidence. Although the exact physiopathology of the PAS is still unknow, there is a consensus that increase in the caesarean section rates, uterine surgery and the advanced maternal age are important contributory factors. Traditionally, the treatment for PAS has been a peripartum hysterectomy but recently, conservative measures such as Intentional Retention of Placenta (IRP) and Triple P technique have been reported. Objectives: To determine which conservative treatment of PAS, IRP vs Triple P technique, has lower postpartum hysterectomy rate in pregnant women with PAS. Secondary objectives are to compare which has a lower rate of early postpartum haemorrhage, endometritis, shorter time to complete involution of retained placental tissue and lower rate of uterine curettage to remove placental tissue. Design: It is a multicentre, controlled, open-label, randomised clinical trial carried out in 11 hospital in Spain. The study population is based on pregnant women ≥18 years old with prenatal diagnosis confirmed of PAS by ultrasound and MRI. The sample size will be 132 patients, 66 in each group, who meet inclusion criteria. Methods: The primary dependent variable will be the postpartum hysterectomy rate and the secondary variables will be early postpartum haemorrhage rate, postpartum endometritis rate, time of placenta involution and uterine curettage rate to remove placental tissue. We will include some covariables that may influence the outcome of our study. The patients will be randomised in two groups: Intentional Retention of Placenta or Triple P technique. We will follow-up these patients every two weeks for 4 months. The results will be analysed and compared in the two different groups

3