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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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.

Con
Sponsor: University Hospital, Angers

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Angers

Dates:
Date Received: May 19, 2016
Date Started: November 2013
Date Completion: November 2016
Last Updated: May 24, 2016
Last Verified: May 2016