Clinical Situations at High Risk of Placenta Accreta / Percreta

Placenta Accreta / Percreta Clinical Trial

— Paccreta  

Official title:

Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010229
• Other study ID #: NI11061
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: December 11, 2017
• Start date: November 4, 2013
• Est. completion date: August 31, 2017

Study information

• Verified date: December 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: August 31, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta / Percreta

Locations

Country	Name	City	State
France	Hôpital Louis Mourier (APHP)	Colombes

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe postpartum hemorrhage	Severe hemorrhage defined by a hemorrhage with transfusion of at least four red blood cell units.	up to 7 days post delivery
Secondary	Incidence of accreta or percreta placenta overall and in women with previous caesarean section and placenta praevia	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	At delivery
Secondary	Predictive value of prenatal ultrasound and MRI for the diagnosis of placenta accreta in women with previous caesarean section and placenta praevia	Sensitivity, specificity and positive and negative predictive values.	at delivery
Secondary	severe maternal morbidity	haemorrhage, infection, intraoperative and postoperative complications, thromboembolic complications.	up to 6 months post-delivery
Secondary	Psychological impact	All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress).	at 1 year post-delivery
Secondary	Psychological impact	All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)	at 1 month post-delivery
Secondary	Psychological impact	All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)	at 6 month post-delivery