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

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ClinicalTrials.gov Identifier: NCT02010229
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Inserm U953 (Epidemiological research unit on perinatal health and women's and children's health) Paris, France
University Hospital, Angers
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 674 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.
Actual Study Start Date : November 4, 2013
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women delivering in maternity units of 8 French regions.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010229


Locations
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France
Hôpital Louis Mourier (APHP)
Colombes, France, 92700
Sponsors and Collaborators
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
Investigators
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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

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02010229     History of Changes
Other Study ID Numbers: NI11061
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Placenta accreta
previous caesarean
placenta praevia
severe obstetric haemorrhage
population-based study
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases