Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03188731 |
| Other study ID # |
734548PW (EC | H2020 | RIA) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 24, 2017 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
University of Heidelberg Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV)
infections in pregnancy and congenital malformations. We will estimate the absolute and
relative risks of congenital malformations and other adverse outcomes of pregnancy among
women who become infected with ZIKV during pregnancy compared to uninfected pregnant women,
also leading to further validation of the Congenital Zika Syndrome.
Description:
The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV)
infections in pregnancy and congenital malformations. We will estimate the absolute and
relative risks of congenital malformations and other adverse outcomes of pregnancy among
women who become infected with ZIKV during pregnancy compared to uninfected pregnant women,
also leading to further validation of the Congenital Zika Syndrome.
We will also determine the ZIKV maternal to child transmission rate and evaluate co-factors
or effect modifiers that account for the large variability seen in the preliminary absolute
risk estimates derived from population figures and reporting of microcephaly in different
states in Brazil and across Latin America.
We will carry out a pregnant women (PW) multicentre cohort study in areas across Latin
America and the Caribbean. Women will be enrolled early in pregnancy and followed every 4
weeks, in connection with their routine antenatal care visits. At each visit, urine and blood
samples will be collected, tested and stored.
Among PW reporting recent or current undifferentiated fever/rash syndrome at any point in
time, the acute illness episode will be characterized in greater detail. PW with suspected
ZIKV infection (i.e. meeting the Pan American Health Organization (PAHO) clinical case
definition) during pregnancy will be managed according to national protocols. Irrespective of
symptoms, pregnant women will be followed prospectively and revisited at birth (or after
abortion) for a detailed documentation of the outcome of their pregnancy.
Live newborns will receive a detailed neonatal examination. In the course of examination of
the newborns, biological samples will be collected and stored. Other potential causes of
congenital abnormalities (TORCHS infections in the mother, toxic substances, chromosomal
abnormalities), and potential effect modifiers (for example past flavivirus
infections/vaccinations, socio-economic status) will also be assessed.
With appropriate counselling and consent, biological samples of newborns with severe
abnormalities, deceased newborns, stillborn babies, and aborted foetuses from ZIKV-infected
mothers will be collected to help elucidate the aetiological contribution of ZIKV in
neurological and other congenital malformations.
Children of women infected with ZIKV during pregnancy - and a subset of the children born to
uninfected women - will be followed prospectively after birth for the assessment of
neuro-developmental milestones (separate protocol).
