NCT02784886

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

May 19, 2016

Last Update Submit

May 24, 2016

Conditions

Morbidly Adherent PlacentaPlacenta AccretaPlacenta IncretaPlacenta Percreta

Keywords

Placenta accretaprevious caesareanplacenta praeviaCell-free fetal DNABiological markers

Outcome Measures

Primary Outcomes (1)

  • Concentration of cell-free fetal DNA circulating in the maternal plasma

    from 24 weeks gestation to delivery

Secondary Outcomes (7)

  • Sensitivity of the concentration of cell-free fetal DNA

    from 24 weeks gestation to delivery

  • Specificity of the concentration of cell-free fetal DNA

    from 24 weeks gestation to delivery

  • Positive predictive value of concentration of cell-free fetal DNA

    from 24 weeks gestation to delivery

  • Negative predictive value of the concentration of cell-free fetal DNA

    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)

    from 24 weeks gestation to delivery

  • +2 more secondary outcomes

Interventions

Women at high risk of MAPBIOLOGICAL

Blood sample

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • Every woman:
  • not understanding French.
  • refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospita

Angers, 44933, France

Location

Related Publications (4)

  • 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.

    PMID: 11805017BACKGROUND

  • 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.

    PMID: 12928242BACKGROUND

  • 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.

    PMID: 23360123BACKGROUND

  • 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.

    PMID: 23869630BACKGROUND

MeSH Terms

Conditions

Placenta AccretaPlacenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Catherine Deneux-Tharaux, MD, PhD

    Inserm U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Paris, France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 27, 2016

Study Start

November 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2016

Last Updated

May 27, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)