Clinical Trial: Antenatal Diagnosis of Placental Attachment Disorders
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Antenatal Diagnosis of Placental Attachment Disorders
Brief Summary:
The accuracy of sonographic prenatal detection of invasive placentation is unclear. The objective of this prospective, multicenter, observational study is to assess the performance of ultrasound for prenatal identification of invasive placentation in women with placenta previa.
This study involves more than 25 hospitals in Italy.
Detailed Summary:
Background: Morbidly adherent placenta is a spectrum of conditions characterized by an abnormal adherence of the placenta to the implantation site. Three major variants of adherent placentation can be recognized according to the degree of trophoblastic invasion through the myometrium and the uterine serosa: placenta accreta, placenta increta and placenta percreta. All varieties of invasive placentation are associated with a significant increase in maternal morbidity.Placenta previa and previous uterine surgery represent the major risk factors for invasive placentation. Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications such as peripartum blood loss, need for transfusions and rate of hysterectomy, as it allows a preplanned treatment of the condition, however the performance of antenatal ultrasound and of different sonographic signs is not consistent across published studies because of limited sample size, retrospective design, variability of inclusion criteria and definition of invasive placentation.
Objectives: The aim of this study is to systematically assess the performance of ultrasound in the prenatal diagnosis of placenta accreta and its variants and to evaluate the role of the different specific ultrasound signs in predicting disorders of invasive placentation. The sonographic signs assessed in this study were: (1) vascular lacunae within the placenta, (2) loss of normal hypoechoic retroplacental zone, (3) interruption of the bladder line and/or focal exophytic masses extending into the bladder space, considered together and labeled as 'abnormalities of the uterus - bladder interface.
Design:prospective, multicenter, observational study of pregnant women with placenta previa.
Methods: The investigators hypothesized
Sponsor: NICOLA FRATELLI
Current Primary Outcome: diagnostic accuracy of sonographic prenatal detection of invasive placentation [ Time Frame: clinical and histopathological assessment of placental invasion at delivery ]
Original Primary Outcome: Same as current
Current Secondary Outcome: maximum degree of placental invasion [ Time Frame: clinical and histopathological assessment of placental invasion at delivery ]
Original Secondary Outcome: Same as current
Information By: Università degli Studi di Brescia
Dates:
Date Received: April 20, 2015
Date Started: February 2015
Date Completion: December 2018
Last Updated: December 14, 2015
Last Verified: December 2015
