Clinical trial NCT02784886: Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta
Official title: Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbidly Adherent Placenta
Placenta Accreta
Placenta Increta
Placenta Percreta
Keywords: Placenta accreta
previous caesarean
placenta praevia
Cell-free fetal DNA
Biological markers
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Assistance Publique - Hôpitaux de Paris
First posted: 2016-05-27
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility 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

Primary outcomes:
measure: Concentration of cell-free fetal DNA circulating in the maternal plasma
timeFrame: from 24 weeks gestation to delivery
Secondary outcomes:
measure: Sensitivity of the concentration of cell-free fetal DNA
timeFrame: from 24 weeks gestation to delivery
measure: Specificity of the concentration of cell-free fetal DNA
timeFrame: from 24 weeks gestation to delivery
measure: Positive predictive value of concentration of cell-free fetal DNA
timeFrame: from 24 weeks gestation to delivery
measure: Negative predictive value of the concentration of cell-free fetal DNA
timeFrame: from 24 weeks gestation to delivery
measure: 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)
timeFrame: from 24 weeks gestation to delivery
measure: Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of concentration of cell-free fetal DNA in association with imaging criteria magnetic resonance
timeFrame: from 24 weeks gestation to delivery
measure: 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
timeFrame: from 24 weeks gestation to delivery
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospita
Study officials:
affiliation: Inserm U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Paris, France
name: Catherine Deneux-Tharaux, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Jimbo 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.
citation: Kayem 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.
citation: Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.