Morbidly Adherent PlacentaDNA-AccretaNCT02784886
Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta
An observational study of Morbidly Adherent Placenta and Placenta Accreta, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to determine whether, in a high risk population (placenta praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)), the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in the subgroup of morbidly adherent… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Morbidly Adherent Placenta, Placenta Accreta, Placenta Increta
- What is being tested?
- Women at high risk of MAP
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2016
- 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 5 maternity units that participate in a Population-based prospective observational study of pregnant women with a placenta praevia and previous cesarean or with prenatal suspicion of accreta (PACCRETA)
Who may be able to join
- Every woman:
- delivering in one of the 5 maternity units that participate to a Population-based prospective observational study of pregnant women with a placenta praevia and previous cesarean or with prenatal suspicion of accreta (PACCRETA) .
- With a placenta praevia and at least one previous cesarean delivery or having a prenatal suspicion of 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: Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population
The purpose of this study is to determine whether, in a high risk population (placenta praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)), the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI).
Read the detailed description
Background: Morbidly adherent placenta (MAP) is a life-threatening condition characterized by placental villi being abnormally adherent to the myometrium. Prenatal identification of MAP is essential to anticipate the risk and plan optimal delivery conditions for these women while this is associated to a maternal outcome improvement. Prenatal identification based on Doppler ultrasound and/or MRI is associated with high rates of false-positive or false-negative findings responsible for adverse effects. Some cases reports have suggested that the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in a context of morbidly adherent placenta (MAP).
Objective: The primary objective is to determine whether the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in women with morbidly adherent placenta (MAP) compared to women with placenta praevia and previous caesarean. Secondary objectives are to determine whether cell-free fetal DNA circulating in the maternal plasma is a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI), in a high risk population (placenta praevia and previous caesarean or only prenatal suspicion of MAP).
Design: Prospective observational study of pregnant women with placenta praevia and previous cesaeran or with prenatal suspicion of placenta accreta, conducted in 5 centers.
Methods: We expect to include 83 women at risk of MAP in two years, of whom approximately 17 (20%) will have a MAP.
Main outcome measures: The primary outcome measure is concentration of cell-free fetal DNA circulating in maternal plasma.
Conclusion: This study will be the first prospective study to include women at risk of placenta accreta and to investigate whether the concentration of cell-free fetal DNA circulating in maternal plasma is increased in MAP women and whether it is a useful biological marker to detect prenatally MAP in a high risk population.
- Being tested
- Women at high risk of MAP
- Keywords
- Placenta accreta, previous caesarean, placenta praevia, Cell-free fetal DNA, Biological markers
- 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.
Women at high risk of MAPBiological
Blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of cell-free fetal DNA circulating in the maternal plasma
Measured: from 24 weeks gestation to delivery
Secondary outcomes (7)
Sensitivity of the concentration of cell-free fetal DNA
Measured: from 24 weeks gestation to delivery
Specificity of the concentration of cell-free fetal DNA
Measured: from 24 weeks gestation to delivery
Positive predictive value of concentration of cell-free fetal DNA
Measured: from 24 weeks gestation to delivery
Negative predictive value of the concentration of cell-free fetal DNA
Measured: from 24 weeks gestation to delivery
Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA in association with clinical criteria ( risk factors for MAP)
Measured: from 24 weeks gestation to delivery
Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of concentration of cell-free fetal DNA in association with imaging criteria magnetic resonance
Measured: from 24 weeks gestation to delivery
Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA and clinical criteria in association with clinical criteria, sonographic criteria and with magnetic resonance imaging criteria
Measured: from 24 weeks gestation to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startNov 2013
- Primary completionNov 2015
- Study completionNov 2016 (estimated)
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 Morbidly Adherent PlacentaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Catherine Deneux-Tharaux, MD, PhD, Study director, Inserm U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784886
- Sponsor's protocol ID
- DC-2011-1467
- Acronym
- DNA-Accreta
- Status last verified
- May 2016
- First submitted
- 19 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sekizawa A, Jimbo M, Saito H, Iwasaki M, Sugito Y, Yukimoto Y, Otsuka J, Okai T. Increased cell-free fetal DNA in plasma of two women with invasive placenta. Clin Chem. 2002 Feb;48(2):353-4. No abstract available.
PubMed 11805017Jimbo M, Sekizawa A, Sugito Y, Matsuoka R, Ichizuka K, Saito H, Okai T. Placenta increta: Postpartum monitoring of plasma cell-free fetal DNA. Clin Chem. 2003 Sep;49(9):1540-1. doi: 10.1373/49.9.1540. No abstract available.
PubMed 12928242Kayem G, Deneux-Tharaux C, Sentilhes L; PACCRETA group. PACCRETA: clinical situations at high risk of placenta ACCRETA/percreta: impact of diagnostic methods and management on maternal morbidity. Acta Obstet Gynecol Scand. 2013 Apr;92(4):476-82. doi: 10.1111/aogs.12078. Epub 2013 Feb 15.
PubMed 23360123Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.
PubMed 23869630
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population
- ClinicalTrials.gov ID
- NCT02784886
- Acronym / sponsor ID
- DNA-Accreta / DC-2011-1467
- Keywords
- Placenta accreta, previous caesarean, placenta praevia, Cell-free fetal DNA, Biological markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Assistance Publique - Hôpitaux de Paris
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 27 May 2016 (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 determine whether, in a high risk population (placenta praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)), the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI).
Detailed description
Background: Morbidly adherent placenta (MAP) is a life-threatening condition characterized by placental villi being abnormally adherent to the myometrium. Prenatal identification of MAP is essential to anticipate the risk and plan optimal delivery conditions for these women while this is associated to a maternal outcome improvement. Prenatal identification based on Doppler ultrasound and/or MRI is associated with high rates of false-positive or false-negative findings responsible for adverse effects. Some cases reports have suggested that the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in a context of morbidly adherent placenta (MAP).
Objective: The primary objective is to determine whether the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in women with morbidly adherent placenta (MAP) compared to women with placenta praevia and previous caesarean. Secondary objectives are to determine whether cell-free fetal DNA circulating in the maternal plasma is a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI), in a high risk population (placenta praevia and previous caesarean or only prenatal suspicion of MAP).
Design: Prospective observational study of pregnant women with placenta praevia and previous cesaeran or with prenatal suspicion of placenta accreta, conducted in 5 centers.
Methods: We expect to include 83 women at risk of MAP in two years, of whom approximately 17 (20%) will have a MAP.
Main outcome measures: The primary outcome measure is concentration of cell-free fetal DNA circulating in maternal plasma.
Conclusion: This study will be the first prospective study to include women at risk of placenta accreta and to investigate whether the concentration of cell-free fetal DNA circulating in maternal plasma is increased in MAP women and whether it is a useful biological marker to detect prenatally MAP in a high risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 5 maternity units that participate in a Population-based prospective observational study of pregnant women with a placenta praevia and previous cesarean or with prenatal suspicion of accreta (PACCRETA)
Key inclusion criteria (4 listed)
- delivering in one of the 5 maternity units that participate to a Population-based prospective observational study of pregnant women with a placenta praevia and previous cesarean or with prenatal suspicion of accreta (PACCRETA) .
- With a placenta praevia and at least one previous cesarean delivery or having a prenatal suspicion of 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women at high risk of MAPBlood sample | Biological | – |
Primary outcome
Concentration of cell-free fetal DNA circulating in the maternal plasma
Time frame: from 24 weeks gestation to delivery
7 secondary outcomes
Sensitivity of the concentration of cell-free fetal DNA
Time frame: from 24 weeks gestation to delivery
Specificity of the concentration of cell-free fetal DNA
Time frame: from 24 weeks gestation to delivery
Positive predictive value of concentration of cell-free fetal DNA
Time frame: from 24 weeks gestation to delivery
Negative predictive value of the concentration of cell-free fetal DNA
Time frame: from 24 weeks gestation to delivery
Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA in association with clinical criteria ( risk factors for MAP)
Time frame: from 24 weeks gestation to delivery
Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of concentration of cell-free fetal DNA in association with imaging criteria magnetic resonance
Time frame: from 24 weeks gestation to delivery
Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA and clinical criteria in association with clinical criteria, sonographic criteria and with magnetic resonance imaging criteria
Time frame: from 24 weeks gestation to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Background: PubMed 11805017Sekizawa A, Jimbo M, Saito H, Iwasaki M, Sugito Y, Yukimoto Y, Otsuka J, Okai T. Increased cell-free fetal DNA in plasma of two women with invasive placenta. Clin Chem. 2002 Feb;48(2):353-4. No abstract available.
- Background: PubMed 12928242Jimbo M, Sekizawa A, Sugito Y, Matsuoka R, Ichizuka K, Saito H, Okai T. Placenta increta: Postpartum monitoring of plasma cell-free fetal DNA. Clin Chem. 2003 Sep;49(9):1540-1. doi: 10.1373/49.9.1540. No abstract available.
- Background: PubMed 23360123Kayem G, Deneux-Tharaux C, Sentilhes L; PACCRETA group. PACCRETA: clinical situations at high risk of placenta ACCRETA/percreta: impact of diagnostic methods and management on maternal morbidity. Acta Obstet Gynecol Scand. 2013 Apr;92(4):476-82. doi: 10.1111/aogs.12078. Epub 2013 Feb 15.
- Background: PubMed 23869630Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.
- Individual participant dataSharing planned: No
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.
Catherine Deneux-Tharaux, MD, PhD study director
Inserm U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, 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 Morbidly Adherent Placenta and Placenta Accreta, run by University Hospital, Angers 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: status not confirmed, as of the sponsor's last update on 27 May 2016. 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?
Results are not available in the source record.
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?
Concentration of cell-free fetal DNA circulating in the maternal plasma (time frame: from 24 weeks gestation to 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 NCT02784886, 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 27 May 2016.