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Zika in pregnancy: major study tracks birth defects in french caribbean

NCT ID NCT02916732

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study observed nearly 27,000 pregnant women in French Caribbean departments during the 2016 Zika epidemic. Researchers tracked Zika infections and their impact on pregnancy, including rates of microcephaly and other fetal abnormalities. The goal was to better understand the risks of Zika during pregnancy using routine medical data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide crucial data on how Zika infection during pregnancy affects fetal development, helping guide future prevention and care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly lead to a cure or therapy. Results may be limited by the specific population and epidemic context.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

26,980 people

The number who actually took part.

Started

Apr 2016

Finished

Feb 2019

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 60 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities microcephaly Zika virus congenital syndrome Zika virus infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Incidence of zikv infection on fetus during the pregnancy

Contacts and locations

Locations

  • CH Andrée Rosemon (CHAR)

    Cayenne, French Guiana

  • CH de l'Ouest Guyanais Franck Joly (CHOG)

    Saint-Laurent-du-Maroni, French Guiana

  • CHU de Martinique

    Fort-de-France, Martinique

  • CHU de Pointe à Pitre/Les Abymes

    Pointe-à-Pitre, Guadeloupe