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CompletedNCT02010229PaccretaUpdated Mar 10, 2026

Clinical Situations at High Risk of Placenta Accreta / Percreta

An observational study in Placenta Accreta / Percreta, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
674
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Placenta Accreta / Percreta

Keywords

  • Placenta accreta
  • previous caesarean
  • placenta praevia
  • severe obstetric haemorrhage
  • population-based study
03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's enrollment of 674 is above the median of 87 across 78 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women delivering in maternity units of 8 French regions.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Every woman:

  • not understanding French.
  • refusing to participate in the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
674 participants (actual)
Patient registry
No

Groups and cohorts

  • women at high risk of placenta accreta

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

06

What researchers measure

Primary outcomes

  1. Severe postpartum hemorrhage

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

    Time frame: up to 7 days post delivery

Secondary outcomes

  1. 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

    Time frame: At delivery

  2. 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.

    Time frame: at delivery

  3. severe maternal morbidity

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

    Time frame: up to 6 months post-delivery

  4. Psychological impact

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

    Time frame: at 1 year post-delivery

  5. Psychological impact

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

    Time frame: at 1 month post-delivery

  6. Psychological impact

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

    Time frame: at 6 month post-delivery

07

Study locations

1 site
  • Hôpital Louis Mourier (APHP)
    Colombes, 92700, France
08

References and documents

Publications

  • 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. PubMed 33393174 ↗
  • 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. PubMed 37226308 ↗
  • 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. PubMed 35772474 ↗
  • 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. PubMed 34914894 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2013 to primary completion in Nov 2016, 36 months.

Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2013
First posted
Dec 12, 2013
StartActual
Nov 4, 2013
Primary completionActual
Nov 30, 2016
CompletionActual
Aug 31, 2017
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02010229
Collaborators
Inserm U953 (Epidemiological research unit on perinatal health and women's and children's health) Paris, France, University Hospital, Angers, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Dec 12, 2013
Start date
Nov 4, 2013
Primary completion
Nov 30, 2016
Completion
Aug 31, 2017
Last update
Mar 10, 2026

Study contacts

Gilles Kayem, MD, PhD
principal investigator · Louis Mourier University Hospital (APHP), department of gynaecology and obstetrics, Colombes, France
Loic Sentilhes, MD, PhD
principal investigator · Angers University Hospital, department of gynaecology and obstetrics, France
Catherine Deneux-Tharaux, MD, PhD
study director · INSERM U953, Epidemiological research unit on perinatal health and children's and women's health, Paris, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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