Placenta Accreta / Percreta
Conditions
Keywords
Placenta accreta, previous caesarean, placenta praevia, severe obstetric haemorrhage, population-based study
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Inserm U953 (Epidemiological research unit on perinatal health and women's and children's health) Paris, France
University Hospital, Angers
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Every woman: * delivering in a maternity unit of the 11 participating perinatal networks. * With a placenta praevia and at least one previous cesarean delivery, and / or having a placenta accreta * aged 18 or more
Exclusion criteria
Every woman: * not understanding French. * refusing to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe postpartum hemorrhage | up to 7 days post delivery | Severe hemorrhage defined by a hemorrhage with transfusion of at least four red blood cell units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of accreta or percreta placenta overall and in women with previous caesarean section and placenta praevia | At delivery | Number of women with placenta accreta divided 1)by the number of parturient women, and 2) by the number of women with previous caesarean section and placenta praevia |
| Predictive value of prenatal ultrasound and MRI for the diagnosis of placenta accreta in women with previous caesarean section and placenta praevia | at delivery | Sensitivity, specificity and positive and negative predictive values. |
| severe maternal morbidity | up to 6 months post-delivery | haemorrhage, infection, intraoperative and postoperative complications, thromboembolic complications. |
| Psychological impact | at 1 year post-delivery | All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGilles Kayem, MD, PhD
Louis Mourier University Hospital (APHP), department of gynaecology and obstetrics, Colombes, France
PRINCIPAL_INVESTIGATORLoic Sentilhes, MD, PhD
Angers University Hospital, department of gynaecology and obstetrics, France
STUDY_DIRECTORCatherine Deneux-Tharaux, MD, PhD
INSERM U953, Epidemiological research unit on perinatal health and children's and women's health, Paris, France
Outcome results
None listed