Clinical Situations at High Risk of Placenta Accreta / Percreta (Paccreta)
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|ClinicalTrials.gov Identifier: NCT02010229|
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 12, 2017
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.
|Condition or disease|
|Placenta Accreta / Percreta|
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.
|Study Type :||Observational|
|Actual Enrollment :||674 participants|
|Official Title:||Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.|
|Actual Study Start Date :||November 4, 2013|
|Actual Primary Completion Date :||November 30, 2016|
|Actual Study Completion Date :||August 31, 2017|
women at high risk of placenta accreta
Parturient women with placenta praevia and at least one previous caesarean delivery
- Severe postpartum hemorrhage [ Time Frame: up to 7 days post delivery ]Severe hemorrhage defined by a hemorrhage with transfusion of at least four red blood cell units.
- Incidence of accreta or percreta placenta overall and in women with previous caesarean section and placenta praevia [ Time Frame: 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 [ Time Frame: at delivery ]Sensitivity, specificity and positive and negative predictive values.
- severe maternal morbidity [ Time Frame: up to 6 months post-delivery ]haemorrhage, infection, intraoperative and postoperative complications, thromboembolic complications.
- Psychological impact [ Time Frame: at 1 year post-delivery ]All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress).
- Psychological impact [ Time Frame: at 1 month post-delivery ]All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)
- Psychological impact [ Time Frame: at 6 month post-delivery ]All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010229
|Hôpital Louis Mourier (APHP)|
|Colombes, France, 92700|
|Principal Investigator:||Gilles Kayem, MD, PhD||Louis Mourier University Hospital (APHP), department of gynaecology and obstetrics, Colombes, France|
|Principal Investigator:||Loic Sentilhes, MD, PhD||Angers University Hospital, department of gynaecology and obstetrics, France|
|Study Director:||Catherine Deneux-Tharaux, MD, PhD||INSERM U953, Epidemiological research unit on perinatal health and children's and women's health, Paris, France|