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Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta (DNA-Accreta)

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ClinicalTrials.gov Identifier: NCT02784886
Recruitment Status : Unknown
Verified May 2016 by University Hospital, Angers.
Recruitment status was:  Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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 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).

Condition or disease Intervention/treatment
Morbidly Adherent Placenta Placenta Accreta Placenta Increta Placenta Percreta Biological: Women at high risk of MAP

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.


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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population
Study Start Date : November 2013
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Women at high risk of MAP
    Blood sample


Primary Outcome Measures :
  1. Concentration of cell-free fetal DNA circulating in the maternal plasma [ Time Frame: from 24 weeks gestation to delivery ]

Secondary Outcome Measures :
  1. Sensitivity of the concentration of cell-free fetal DNA [ Time Frame: from 24 weeks gestation to delivery ]
  2. Specificity of the concentration of cell-free fetal DNA [ Time Frame: from 24 weeks gestation to delivery ]
  3. Positive predictive value of concentration of cell-free fetal DNA [ Time Frame: from 24 weeks gestation to delivery ]
  4. Negative predictive value of the concentration of cell-free fetal DNA [ Time Frame: from 24 weeks gestation to delivery ]
  5. 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 ]
  6. 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 ]
  7. 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 ]


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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 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)
Criteria

Inclusion Criteria:

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

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): NCT02784886


Locations
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France
Angers University Hospita
Angers, France, 44933
Sponsors and Collaborators
University Hospital, Angers
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Catherine Deneux-Tharaux, MD, PhD Inserm U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Paris, France

Publications:
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02784886     History of Changes
Other Study ID Numbers: DC-2011-1467
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Angers:
Placenta accreta
previous caesarean
placenta praevia
Cell-free fetal DNA
Biological markers
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases