Overview

This trial is active, not recruiting.

Condition placenta accreta / percreta
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Inserm U953 (Epidemiological research unit on perinatal health and women's and children's health) Paris, France
Start date November 2013
End date July 2016
Trial size 630 participants
Trial identifier NCT02010229, NI11061

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Parturient women with placenta praevia and at least one previous caesarean delivery

Primary Outcomes

Measure
Severe postpartum hemorrhage
time frame: up to 7 days post delivery

Secondary Outcomes

Measure
Incidence of accreta or percreta placenta overall and in women with previous caesarean section and placenta praevia
time frame: At delivery
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
severe maternal morbidity
time frame: up to 6 months post-delivery
Psychological impact
time frame: at 1 year post-delivery
Psychological impact
time frame: at 1 month post-delivery
Psychological impact
time frame: at 6 month post-delivery

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.
Principal investigator Gilles Kayem, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.