Placenta Accreta Clinical Trial
Official title:
Antenatal Diagnosis of Placental Attachment Disorders
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.
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 that ultrasound has a sensitivity of at least 80%
and a specificity of at least 97%, with 10% confidence intervals, for antenatal diagnosis of
invasive placentation.The investigators would require 2048 women with placenta previa, of
whom approximately 61 (3%) will have morbidly adherent placenta, to test the null hypothesis
with a 0.05 risk of type I error (alpha). Supposing a 10% of women with incomplete follow up
the investigators aim to enroll 2254 women in this study.
Diagnostic criteria that suggested placenta accreta, increta, or percreta included one or
more of the following situations: (1) obliteration of the clear space, defined as the
obliteration of any part of the echolucent area located between the uterus and placenta; (2)
visualization of placental lacunae, defined as multiple linear, irregular vascular spaces
within the placenta; and (3) interruption of the posterior bladder wall-uterine interface
such that the usual continuous echolucent line appears instead as a series of dashes.
The degree of placental invasion was defined as follows: (i) placenta accreta was assumed
when placental 'cones' disrupted the decidual zone with mildly increased vascularization
around these cones ; (ii) placenta increta was diagnosed when placental invasion into the
myometrium was sonographically suspected as a result of the presence of irregular and
diffuse demarcation of the placental - uterine wall interface and thinning of the myometrium
that was overlying the placental - myometrial tissue. Placenta increta was also
characterized by increased vascularization and irregularly shaped intraplacental vascular
lacunae, resembling the characteristic 'moth damage' appearance ; and (iii) the sonographic
finding of placenta percreta was defined by a complete absence of the myometrium, with the
placenta extending to the serosa, or beyond, including vascular breakthrough.In addition,
placenta percreta was also characterized by massive subplacental hypervascularization, with
vessels extending irregularly into the placental - myometrial tissue and with numerous large
intraplacental lacunae.
Clinical and histopathological assessment of placental invasion:
Sonographic findings were compared with the clinical outcome during and after delivery and
the histomorphological examination of the placenta, performed by pathologists experienced in
obstetric histopathology, who were blinded to the sonographic findings.
..........................................................................................................
Main Outcomes measure:
Primary Outcome: sensitivity (SN), specificity(SP), positive likelihood ratio (LR+),
negative likelihood ratio (LR - ) and diagnostic odds ratio (DOR) of antenatal ultrasound
and different sonographic signs for in prediction of morbidly adherent placenta.
Secondary Outcome: to evaluate whether the maximum degree of placental invasion (placenta
accreta, increta or percreta) can be predicted with antenatal ultrasound.
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Observational Model: Case-Only, Time Perspective: Prospective
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