Placenta Accreta / PercretaPaccretaNCT02010229
Clinical Situations at High Risk of Placenta Accreta / Percreta
An observational study of Placenta Accreta / Percreta, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placenta Accreta / Percreta
- How many people
- 674 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2013to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women delivering in maternity units of 8 French regions.
Who may be able to join
- 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
Who cannot join
- Every woman:
- not understanding French.
- refusing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.
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.
- Conditions
- Placenta Accreta / Percreta
- Keywords
- Placenta accreta, previous caesarean, placenta praevia, severe obstetric haemorrhage, population-based study
- Medical subject headings
- Placenta Accreta, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women at high risk of placenta accreta | Parturient women with placenta praevia and at least one previous caesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe postpartum hemorrhage
Severe hemorrhage defined by a hemorrhage with transfusion of at least four red blood cell units.
Measured: 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
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
Measured: At delivery
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.
Measured: at delivery
severe maternal morbidity
haemorrhage, infection, intraoperative and postoperative complications, thromboembolic complications.
Measured: up to 6 months post-delivery
Psychological impact
All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress).
Measured: at 1 year post-delivery
Psychological impact
All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)
Measured: at 1 month post-delivery
Psychological impact
All the women will receive several validated auto-questionnaires (postpartum depression, anxiety, post-traumatic stress)
Measured: at 6 month post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study start4 Nov 2013
- Primary completion30 Nov 2016
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Placenta Accreta / PercretaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Gilles Kayem, MD, PhD, Principal investigator, Louis Mourier University Hospital (APHP), department of gynaecology and obstetrics, Colombes, FranceLoic Sentilhes, MD, PhD, Principal investigator, Angers University Hospital, department of gynaecology and obstetrics, FranceCatherine Deneux-Tharaux, MD, PhD, Study director, INSERM U953, Epidemiological research unit on perinatal health and children's and women's health, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010229
- Sponsor's protocol ID
- NI11061
- Acronym
- Paccreta
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2013
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
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 33393174Pinton 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 37226308Sentilhes 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 35772474Sentilhes 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.
- ClinicalTrials.gov ID
- NCT02010229
- Acronym / sponsor ID
- Paccreta / NI11061
- Conditions
- Placenta Accreta / Percreta
- Keywords
- Placenta accreta, previous caesarean, placenta praevia, severe obstetric haemorrhage, population-based study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- 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
- Study start
- 4 Nov 2013 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women at high risk of placenta accreta | – | –Parturient women with placenta praevia and at least one previous caesarean delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women delivering in maternity units of 8 French regions.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- not understanding French.
- refusing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Incidence of accreta or percreta placenta overall and in women with previous caesarean section and placenta praevia
Time frame: At delivery
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
severe maternal morbidity
Time frame: up to 6 months post-delivery
Psychological impact
Time frame: at 1 year post-delivery
Psychological impact
Time frame: at 1 month post-delivery
Psychological impact
Time frame: at 6 month post-delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 33393174Kayem 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.
- Results publication: PubMed 37226308Pinton 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.
- Results publication: PubMed 35772474Sentilhes 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.
- Results publication: PubMed 34914894Sentilhes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta / Percreta, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe postpartum hemorrhage (time frame: up to 7 days post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02010229, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.