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Completed

NCT Number: NCT02010229

Clinical Situations at High Risk of Placenta Accreta / Percreta

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.

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Key information

Conditions

Placenta Accreta / Percreta Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Placenta Previa Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Louis Mourier (APHP)

Colombes, 92700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Severe postpartum hemorrhage

    Time frame: up to 7 days post delivery

    Severe hemorrhage defined by a hemorrhage with transfusion of at least four red blood cell units.

Secondary outcomes

  1. Incidence of accreta or percreta placenta overall and in women with previous caesarean section and placenta praevia

    Time frame: 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

  2. Predictive value of prenatal ultrasound and MRI for the diagnosis of placenta accreta in women with previous caesarean section and placenta praevia

    Time frame: at delivery

    Sensitivity, specificity and positive and negative predictive values.

  3. severe maternal morbidity

    Time frame: up to 6 months post-delivery

    haemorrhage, infection, intraoperative and postoperative complications, thromboembolic complications.

  4. Psychological impact

    Time frame: at 1 year post-delivery

    All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress).

  5. Psychological impact

    Time frame: at 1 month post-delivery

    All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)

  6. Psychological impact

    Time frame: at 6 month post-delivery

    All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Paccreta

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 12, 2013
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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