Clinical trial NCT02010229: Clinical Situations at High Risk of Placenta Accreta / Percreta
Official title: Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta / Percreta
Keywords: Placenta accreta
previous caesarean
placenta praevia
severe obstetric haemorrhage
population-based study
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Inserm U953 (Epidemiological research unit on perinatal health and women's and children's health) Paris, France
name: University Hospital, Angers
First posted: 2013-12-12
Enrollment: 674
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women delivering in maternity units of 8 French regions.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severe postpartum hemorrhage
timeFrame: 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
timeFrame: At delivery
measure: Predictive value of prenatal ultrasound and MRI for the diagnosis of placenta accreta in women with previous caesarean section and placenta praevia
timeFrame: at delivery
measure: severe maternal morbidity
timeFrame: up to 6 months post-delivery
measure: Psychological impact
timeFrame: at 1 year post-delivery
measure: Psychological impact
timeFrame: at 1 month post-delivery
measure: Psychological impact
timeFrame: at 6 month post-delivery
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hôpital Louis Mourier (APHP)
Study officials:
affiliation: Louis Mourier University Hospital (APHP), department of gynaecology and obstetrics, Colombes, France
name: Gilles Kayem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Angers University Hospital, department of gynaecology and obstetrics, France
name: Loic Sentilhes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM U953, Epidemiological research unit on perinatal health and children's and women's health, Paris, France
name: Catherine Deneux-Tharaux, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.