Clinical trial NCT02916732: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence of ZIKV Infection on Fetus During the Pregnancy
Keywords: asymptomatics
microcephaly
abnormalities
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2016-09-27
Enrollment: 26980
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Incidence of ZIKV infection during pregnancy
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of microcephaly and other fetal abnormalities
timeFrame: 12 month
Other outcomes:
measure: Analysis of risk factor for the occurence of congenital abnormalities
timeFrame: 12 month
Locations:
city: Cayenne Cedex
country: France
facility: CH Andrée Rosemon (CHAR)
city: FORT DE France Cedex
country: France
facility: CHU de Martinique
city: Pointe A Pitre
country: France
facility: CHU de Pointe à Pitre/Les Abymes
city: Saint-laurent-du-maroni
country: France
facility: CH de l'Ouest Guyanais Franck Joly (CHOG)
Study officials:
References:
citation: Funk AL, Hoen B, Vingdassalom I, Ryan C, Kadhel P, Schepers K, Gaete S, Tressieres B, Fontanet A. Reassessment of the risk of birth defects due to Zika virus in Guadeloupe, 2016. PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009048. doi: 10.1371/journal.pntd.0009048. eCollection 2021 Mar.
citation: Hoen B, Schaub B, Funk AL, Ardillon V, Boullard M, Cabie A, Callier C, Carles G, Cassadou S, Cesaire R, Douine M, Herrmann-Storck C, Kadhel P, Laouenan C, Madec Y, Monthieux A, Nacher M, Najioullah F, Rousset D, Ryan C, Schepers K, Stegmann-Planchard S, Tressieres B, Volumenie JL, Yassinguezo S, Janky E, Fontanet A. Pregnancy Outcomes after ZIKV Infection in French Territories in the Americas. N Engl J Med. 2018 Mar 15;378(11):985-994. doi: 10.1056/NEJMoa1709481.