Clinical Situations at High Risk of Placenta Accreta / Percreta

NCT02010229 | Completed

• 1 other identifier: NI11061
• Study Type: observational
• Target: 674
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta / Percreta

Keywords

Placenta accreta; previous caesarean; placenta praevia; severe obstetric haemorrhage; population-based study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of accreta or percreta placenta overall and in 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

  at delivery

• severe maternal morbidity

  up to 6 months post-delivery

• Psychological impact

  at 1 year post-delivery

• Psychological impact

  at 1 month post-delivery

Study Arms (1)

women at high risk of placenta accreta

Parturient women with placenta praevia and at least one previous caesarean delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women delivering in maternity units of 8 French regions.

You may qualify if:

• 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

You may not qualify if:

• Every woman:
• not understanding French.
• refusing to participate in the study.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Inserm U953 (Epidemiological research unit on perinatal health and women's and children's health) Paris, France: collaborator
• University Hospital, Angers: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Louis Mourier (APHP)

Colombes, 92700, France

Location

Related Publications (4)

• Kayem G, Seco A, Beucher G, Dupont C, Branger B, Crenn Hebert C, Huissoud C, Fresson J, Winer N, Langer B, Rozenberg P, Morel O, Bonnet MP, Perrotin F, Azria E, Carbillon L, Chiesa C, Raynal P, Rudigoz RC, Dreyfus M, Vendittelli F, Patrier S, Deneux-Tharaux C, Sentilhes L. Clinical profiles of placenta accreta spectrum: the PACCRETA population-based study. BJOG. 2021 Sep;128(10):1646-1655. doi: 10.1111/1471-0528.16647. Epub 2021 Feb 3.

  PMID: 33393174 RESULT

• Pinton A, Deneux-Tharaux C, Seco A, Sentilhes L, Kayem G; PACCRETA Study Group. Incidence and risk factors for severe postpartum haemorrhage in women with anterior low-lying or praevia placenta and prior caesarean: Prospective population-based study. BJOG. 2023 Dec;130(13):1653-1661. doi: 10.1111/1471-0528.17554. Epub 2023 May 24.

  PMID: 37226308 RESULT

• Sentilhes L, Seco A, Kayem G, Deneux-Tharaux C. Postdischarge outcomes of readmitted women included in the PACCRETA study. Am J Obstet Gynecol. 2022 Nov;227(5):795-798. doi: 10.1016/j.ajog.2022.06.042. Epub 2022 Jun 27. No abstract available.

  PMID: 35772474 RESULT

• 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.

  PMID: 34914894 RESULT

MeSH Terms

Conditions

Placenta Accreta; Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Catherine Deneux-Tharaux, MD, PhD

  INSERM U953, Epidemiological research unit on perinatal health and children's and women's health, Paris, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 12, 2013
• Study Start: November 4, 2013
• Primary Completion: November 30, 2016
• Study Completion: August 31, 2017
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

FR (1)