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Zika Virus Infection's Pregnancy Consequences in French Department of America (ZIKA-DFA-FE)

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ClinicalTrials.gov Identifier: NCT02916732
Recruitment Status : Unknown
Verified April 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : September 27, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date September 26, 2016
First Posted Date September 27, 2016
Last Update Posted Date September 27, 2016
Study Start Date April 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2016)
Incidence of ZIKV infection during pregnancy [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 26, 2016)
Incidence of microcephaly and other fetal abnormalities [ Time Frame: 12 month ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2016)
Analysis of risk factor for the occurence of congenital abnormalities [ Time Frame: 12 month ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Zika Virus Infection's Pregnancy Consequences in French Department of America
Official Title Études Observationnelles Des conséquences de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016
Brief Summary The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy. This study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of ZIKV infection occurring during pregnancy.
Detailed Description This is a prospective observational, non-interventional study that has been integrated into the usual standard of care practices. All information and biological samples collected during the course of this project will be done through the new medical standard of care which has been put in place during the ZIKV epidemic in the DFAs; this new standard of care is a result of existing recommendations from medical professionals and/or public health authorities. Outside of these recommendations, no invasive procedure will be done simply to satisfy an objective of this study.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 9 Months
Biospecimen Retention:   Samples With DNA
Description:
  • bio-bank of serum from all pregnant women.
  • bio-bank of maternal blood and infant cord blood
  • bio-bank of maternal blood and fetal tissues
Sampling Method Non-Probability Sample
Study Population

The population of this study is women who have been pregnant during the 2016 ZIKV Epidemic in the DFAs. Five study arms (hereafter called 'modules') have been defined with various inclusion criteria for each module.

M1: Pregnant women with clinical signs of acute ZIKV infection

Module 2: Pregnant women for which an abnormality has been detected in the fetus.

Module 3: Bio-bank of serum, collected once per trimester, from all pregnant women.

Module 4: Bio-bank of maternal blood and infant cord blood, taken the day of birth in all mothers and their babies in the 3 DFAs.

Module 5: Bio-bank of maternal blood and fetal tissues from women in whom the pregnancy was terminated due to miscarriage, abortion on medical grounds, or a fetal death in-utero.

Condition Incidence of ZIKV Infection on Fetus During the Pregnancy
Intervention Not Provided
Study Groups/Cohorts
  • Module 1
    Identification and monitoring of pregnant women who develop clinical signs of acute infection due to ZIKV (standard monitoring report)
  • Module 2
    Monitoring of pregnant women with a suspected embryofetopathy (standard monitoring report)
  • Module 3
    Trimester biological collection of all pregnant women during the outbreak of Zika (standard monitoring report)
  • Module 4
    Biological collection of maternal blood and cord blood collected during the delivery
  • Module 5
    Biological collection of maternal blood and fetal tissues of pregnant women whose pregnancies started during the outbreak of Zika , ends in an spontaneous abortion, Induced abortion or intrauterine fetal demise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 26, 2016)
26980
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2019
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

M1:

Inclusion Criteria:

  • On-going pregnancy regardless the presumed date of birth
  • Clinical signs suggestive of ZIKV infection
  • Whatever the RT-PCR analysis

Exclusion Criteria:

  • Minor
  • No consent

M2:

Inclusion Criteria:

  • Head circumference < 5th percentile
  • Other brain morphological abnormality
  • Hydramnios
  • Intrauterine growth restriction (IUGR)

Exclusion Criteria:

  • Minor
  • No consent

M3:

Inclusion Criteria:

  • Pregnant woman during epidemic period of ZIKV

Exclusion Criteria:

  • Minor
  • Opposition

M4:

Inclusion Criteria:

  • Delivery during epidemic period of ZIKV

Exclusion Criteria:

  • Minor
  • No consent

M5:

Inclusion Criteria:

  • Spontaneous abortion or fetal death in utero during epidemic period of ZIKV

Exclusion Criteria:

  • Minor
  • No consent
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02916732
Other Study ID Numbers C16-08
2016-A00399-42 ( Other Identifier: France ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Collaborators Not Provided
Investigators Not Provided
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date April 2016