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

Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02784886
Acronym
DNA-Accreta
Enrollment
63
Registered
2016-05-27
Start date
2013-11-30
Completion date
2016-11-30
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbidly Adherent Placenta, Placenta Accreta, Placenta Increta, Placenta Percreta

Keywords

Placenta accreta, previous caesarean, placenta praevia, Cell-free fetal DNA, Biological markers

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).

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.

Interventions

BIOLOGICALWomen at high risk of MAP

Blood sample

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Concentration of cell-free fetal DNA circulating in the maternal plasmafrom 24 weeks gestation to delivery

Secondary

MeasureTime frame
Specificity of the concentration of cell-free fetal DNAfrom 24 weeks gestation to delivery
Positive predictive value of concentration of cell-free fetal DNAfrom 24 weeks gestation to delivery
Negative predictive value of the concentration of cell-free fetal DNAfrom 24 weeks gestation to delivery
Sensitivity of the concentration of cell-free fetal DNAfrom 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 resonancefrom 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 criteriafrom 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)from 24 weeks gestation to delivery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026