Placenta Accreta / Percreta Clinical Trial
Official title:
Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.
The purpose of this study is to identify what factors -either individual or related to the
type of management received- influence the maternal outcomes in pregnant women at high risk
for placenta accreta i.e , women with placenta praevia and previous caesarean.
This population-based study conducted in 8 French regions will also provide valid estimation
of the incidence of placenta accreta among all parturients and among "at risk "women.
Finally, a psychological evaluation of these women up to 1 year after delivery will provide
information on the impact of these conditions on women, beyond somatic complications.
Background: No population-based study has assessed the prevalence of placenta accreta, the
predictive value of prenatal diagnostic examinations, the maternal morbidity associated with
its management, or its psychological effects. Moreover the technical resources necessary for
the safest delivery of women at risk have not been clearly identified.
Objectives: The primary objectives are to identify individual risk factors for maternal
morbidity, as well as risk factors related to types of management and healthcare facilities
for postpartum hemorrhage (PPH). Secondary objectives are to 1) determine the prevalence of
placenta accreta among women at risk; 2) assess the predictive value of ultrasound and MRI
for the diagnosis of placenta accreta in this population; 3) evaluate psychological impact
and physical complications; 4) report maternal physical complications during the year after
delivery.
Design: Population-based prospective observational study of pregnant women with a placenta
inserted at a uterine scar Setting; A total of 166 centers in 8 French regions, with 260,000
deliveries annually.
Methods: We expect to include 570 women at risk of placenta accreta in two years, of whom
approximately 100 (20%) will have placenta accreta.
Main outcome measures: The primary outcome measure is severe maternal hemorrhage; secondary
outcome measures are maternal morbidity and deaths, predictive value of ultrasound and MRI,
and psychological evaluations at 1, 6 and 12 months after delivery.
Conclusion: This study will be the first prospective population-based study to include women
at risk of placenta accreta and to investigate incidence, prenatal detection, type of
management, morbidity and maternal psychological consequences.
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