Zika VirusZIKAlliancePWNCT03188731
ZIKAlliance Pregnant Women Cohort
An observational study of Zika Virus and Pregnancy Related, run by University of Heidelberg Medical Center at 14 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Zika Virus, Pregnancy Related
- How many people
- 3,852 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 24 May 2017to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant Women
Who may be able to join
- at least 16 years old
- Pregnancy status confirmed
- Within first or second trimester or first month of marked transmission season
Who cannot join
- Planing to leave area
- Unable to attend follow-up visits
- Unable to undergo venipuncture
- Participates in another pregnant women study for ZIKA
- Unable to consent without legal guardian
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Brazil6 sites
Federal University of Bahia (UFB)
Bahia
Universidade Federal de Minas Gerais
Belo Horizonte
Federal University of Goias
Goiás
Fundacao Oswaldo Cruz (FIOCRUZ)
Recife
Fundacao Oswaldo Cruz (FIOCRUZ)
Rio de Janeiro
University of Sao Paulo
São Paulo
Mexico2 sites
IMSS Mexico (IMSS)
Guadalajara
National Institute of Public Health (INSP)
Mérida
About this study
Official title: Pregnant Women (PW) Cohort for Evaluation of Risks of Congenital Malformations and Other Adverse Pregnancy Outcomes After Zika Virus Infection (Part of ZIKAlliance)
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.
Read the detailed 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).
- Conditions
- Zika Virus, Pregnancy Related
- Keywords
- ZIKA, Dengue, Chikungunya, Pregnant Women, Pregnant Woman, ZIKV
- Medical subject headings
- Zika Virus Infection, Dengue, Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Congenital Abnormalities
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start24 May 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zika VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Heidelberg Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, ZIKAlliance, Oswaldo Cruz Foundation, University of Sao Paulo, London School of Hygiene and Tropical Medicine, Federal University of Bahia, Universidade Federal de Goias, University Medical Center Groningen, University of Carabobo, Universidad Industrial de Santander, Sosecali Hospital, Guyaquil, Instituto de Medicina Tropical "Pedro Kourí (IPK), Cuba, Mexican National Institute of Public Health, Instituto Mexicano del Seguro Social, Institut National de la Santé Et de la Recherche Médicale, France, Erasmus Medical Center
- Responsible party
- Principal investigator, Thomas Jaenisch, University of Heidelberg Medical Center
- Investigators
- Thomas Jänisch, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188731
- Sponsor's protocol ID
- 734548PW (EC | H2020 | RIA)
- Acronym
- ZIKAlliancePW
- Status last verified
- May 2022
- First submitted
- 13 Jun 2017
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. The ZIKAlliance birth cohort is part of the 3 EC-funded Zika consortia. The data are intended to be shared after the individual cohort data is analyzed and published. 2. The ZIKAlliance birth cohort is part of the WHO-moderated IPD meta-analysis Consortium. The data are intended to be shared after the individual cohort data is analyzed and published.
Publications
Avelino-Silva VI, Mayaud P, Tami A, Miranda MC, Rosenberger KD, Alexander N, Nacul L, Segurado A, Pohl M, Bethencourt S, Villar LA, Viana IFT, Rabello R, Soria C, Salgado SP, Gotuzzo E, Guzman MG, Martinez PA, Lopez-Gatell H, Hegewisch-Taylor J, Borja-Aburto VH, Gonzalez C, Netto EM, Saba Villarroel PM, Hoen B, Brasil P, Marques ETA, Rockx B, Koopmans M, de Lamballerie X, Jaenisch T; ZIKAlliance Clinical Study Group. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infect Dis. 2019 Dec 26;19(1):1081. doi: 10.1186/s12879-019-4685-9.
PubMed 31878895
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant Women (PW) Cohort for Evaluation of Risks of Congenital Malformations and Other Adverse Pregnancy Outcomes After Zika Virus Infection (Part of ZIKAlliance)
- ClinicalTrials.gov ID
- NCT03188731
- Acronym / sponsor ID
- ZIKAlliancePW / 734548PW (EC | H2020 | RIA)
- Conditions
- Zika Virus, Pregnancy Related
- Keywords
- ZIKA, Dengue, Chikungunya, Pregnant Women, Pregnant Woman, ZIKV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,852 participants (actual)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Collaborators
- European Union, ZIKAlliance, Oswaldo Cruz Foundation, University of Sao Paulo, London School of Hygiene and Tropical Medicine, Federal University of Bahia, Universidade Federal de Goias, University Medical Center Groningen, University of Carabobo, Universidad Industrial de Santander, Sosecali Hospital, Guyaquil, Instituto de Medicina Tropical "Pedro Kourí (IPK), Cuba, Mexican National Institute of Public Health, Instituto Mexicano del Seguro Social, Institut National de la Santé Et de la Recherche Médicale, France, Erasmus Medical Center
- Study start
- 24 May 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | – |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant Women
Key inclusion criteria (3 listed)
- at least 16 years old
- Pregnancy status confirmed
- Within first or second trimester or first month of marked transmission season
Key exclusion criteria (5 listed)
- Planing to leave area
- Unable to attend follow-up visits
- Unable to undergo venipuncture
- Participates in another pregnant women study for ZIKA
- Unable to consent without legal guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Congenital Abnormalities
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 31878895Avelino-Silva VI, Mayaud P, Tami A, Miranda MC, Rosenberger KD, Alexander N, Nacul L, Segurado A, Pohl M, Bethencourt S, Villar LA, Viana IFT, Rabello R, Soria C, Salgado SP, Gotuzzo E, Guzman MG, Martinez PA, Lopez-Gatell H, Hegewisch-Taylor J, Borja-Aburto VH, Gonzalez C, Netto EM, Saba Villarroel PM, Hoen B, Brasil P, Marques ETA, Rockx B, Koopmans M, de Lamballerie X, Jaenisch T; ZIKAlliance Clinical Study Group. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infect Dis. 2019 Dec 26;19(1):1081. doi: 10.1186/s12879-019-4685-9.
- Individual participant dataSharing planned: Yes. 1. The ZIKAlliance birth cohort is part of the 3 EC-funded Zika consortia. The data are intended to be shared after the individual cohort data is analyzed and published. 2. The ZIKAlliance birth cohort is part of the WHO-moderated IPD meta-analysis Consortium. The data are intended to be shared after the individual cohort data is analyzed and published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jänisch principal investigator
University Hospital Heidelberg
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika Virus and Pregnancy Related, run by University of Heidelberg Medical Center at 14 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil, Bolivia, Mexico, Colombia, Cuba and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Congenital Abnormalities (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.