Clinical Situations at High Risk of Placenta Accreta / Percreta (Paccreta)

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

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.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta / Percreta

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 Type: Observational
• Enrollment (Actual): 674

Contacts and Locations

Study Locations

• France
  • Colombes, France, 92700
    • Hôpital Louis Mourier (APHP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women delivering in maternity units of 8 French regions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
women at high risk of placenta accreta; Parturient women with placenta praevia and at least one previous caesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
severe maternal morbidity	haemorrhage, infection, intraoperative and postoperative complications, thromboembolic complications.	up to 6 months post-delivery
Psychological impact	All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress).	at 1 year post-delivery
Psychological impact	All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)	at 1 month post-delivery
Psychological impact	All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)	at 6 month post-delivery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University Hospital, Angers; Inserm U953 (Epidemiological research unit on perinatal health and women's and children's health) Paris, France
• Investigators: 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

Publications and helpful links

General Publications

• Sentilhes L, Seco A, Azria E, Beucher G, Bonnet MP, Branger B, Carbillon L, Chiesa C, Crenn-Hebert C, Dreyfus M, Dupont C, Fresson J, Huissoud C, Langer B, Morel O, Patrier S, Perrotin F, Raynal P, Rozenberg P, Rudigoz RC, Vendittelli F, Winer N, Deneux-Tharaux C, Kayem G; PACCRETA Study Group. Conservative management or cesarean hysterectomy for placenta accreta spectrum: the PACCRETA prospective study. Am J Obstet Gynecol. 2022 Jun;226(6):839.e1-839.e24. doi: 10.1016/j.ajog.2021.12.013. Epub 2021 Dec 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2013
• Primary Completion (ACTUAL): November 30, 2016
• Study Completion (ACTUAL): August 31, 2017

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (ESTIMATE): December 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Placenta accreta; previous caesarean; placenta praevia; severe obstetric haemorrhage; population-based study
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: NI11061