Clinical Situations at High Risk of Placenta Accreta / Percreta

Completed

• Conditions: Placenta Accreta / Percreta

• Registration Number: NCT02010229
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2013-11-04
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Primary Completion: 2016-11-30
• Study Completion: 2017-08-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 674

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
severe maternal morbidity	up to 6 months post-delivery	haemorrhage, infection, intraoperative and postoperative complications, thromboembolic complications.
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.
Psychological impact	at 6 month post-delivery	All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)

Trial Locations

Locations (1)

Hôpital Louis Mourier (APHP); 🇫🇷 Colombes, France