MicrocephalyNCT02741882
Zika and Microcephaly: Case-control Study
An observational study of Microcephaly, run by Laboratório Sabin at 1 site in Brazil.
Trial summary
It is suspected that zika virus infection during pregnancy is associated with microcephaly. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microcephaly
- What is being tested?
- Questionary
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Feb 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mothers who delivered their babies at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016.
Who may be able to join
- Delivered a baby at nossa senhora de lourdes maternity from September 1, 2015 through january 5, 2016.
Who cannot join
- Syphilis during pregnancy, toxoplasmosis during pregnancy, consanguinity, other genetics disorder, alcohol or abuse drug consumption during pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rash Accompanied by Three or More Dengue-like Symptoms During Pregnancy and Microcephaly: Case-control Study
It is suspected that zika virus infection during pregnancy is associated with microcephaly. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design.
Read the detailed description
The investigators will carry out a case-control study among mothers who delivered their babies at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. Data sources for the phase I of the study will consist of medical records review and a standard questionnaire applied by telephone to collect information about demographic features, clinical signs and symptoms, and the duration and severity of the illness. Phase II will include dengue, chikungunya and dengue serologic test results as secondary outcome, if available. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design
- Conditions
- Microcephaly
- Being tested
- Questionary
- Keywords
- Microcephaly, zika Virus, Case-control study
- Medical subject headings
- Microcephaly, Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaryOther
Questionary with clinical, demographic and behavior outcomes at the pregnancy period
| Study group | Role | What they receive |
|---|---|---|
| Cases | Mothers who delivered a baby with microcephaly at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. The intervention will be a questionary. Receives: Other: Questionary | |
| Controls | Mothers who delivered a baby without microcephaly at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. The intervention will be a questionary. Receives: Other: Questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zika virus infection clinical outcomes during pregnancy
acute onset of generalized rash together with three of the following symptoms: Conjunctivitis, arthralgia, mild-fever or periarticular edema.
Measured: From September 1, 2015 through January 5, 2016
Secondary outcomes (3)
zika virus serology
If available, zika virus serology will be performed
Measured: march, 2016 through July 5, 2016
Chikungunya virus serology
If available, chikungunya virus serology will be performed
Measured: march, 2016 through July 5, 2016
Dengue virus serology
If available, Dengue virus serology will be performed
Measured: march, 2016 through July 5, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionFeb 2017
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 MicrocephalyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratório Sabin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Gustavo Barcelos Barra, Laboratório Sabin
- Investigators
- Gustavo B Barra, ph.D, Principal investigator, Sabin Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741882
- Sponsor's protocol ID
- Zika and microcephaly
- Status last verified
- Feb 2017
- First submitted
- 13 Apr 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Santa Rita TH, Barra RB, Peixoto GP, Mesquita PG, Barra GB. Association between suspected Zika virus disease during pregnancy and giving birth to a newborn with congenital microcephaly: a matched case-control study. BMC Res Notes. 2017 Sep 6;10(1):457. doi: 10.1186/s13104-017-2796-1.
PubMed 28877754
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rash Accompanied by Three or More Dengue-like Symptoms During Pregnancy and Microcephaly: Case-control Study
- ClinicalTrials.gov ID
- NCT02741882
- Acronym / sponsor ID
- Zika and microcephaly
- Conditions
- Microcephaly
- Keywords
- Microcephaly, zika Virus, Case-control study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Laboratório SabinIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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.
It is suspected that zika virus infection during pregnancy is associated with microcephaly. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design.
Detailed description
The investigators will carry out a case-control study among mothers who delivered their babies at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. Data sources for the phase I of the study will consist of medical records review and a standard questionnaire applied by telephone to collect information about demographic features, clinical signs and symptoms, and the duration and severity of the illness. Phase II will include dengue, chikungunya and dengue serologic test results as secondary outcome, if available. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: QuestionaryMothers who delivered a baby with microcephaly at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. The intervention will be a questionary. |
| Controls | – | Other: QuestionaryMothers who delivered a baby without microcephaly at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. The intervention will be a questionary. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers who delivered their babies at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016.
Key inclusion criteria (1 listed)
- Delivered a baby at nossa senhora de lourdes maternity from September 1, 2015 through january 5, 2016.
Key exclusion criteria (1 listed)
- Syphilis during pregnancy, toxoplasmosis during pregnancy, consanguinity, other genetics disorder, alcohol or abuse drug consumption during pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionaryQuestionary with clinical, demographic and behavior outcomes at the pregnancy period | Other | Cases, Controls |
Primary outcome
Zika virus infection clinical outcomes during pregnancy
Time frame: From September 1, 2015 through January 5, 2016
acute onset of generalized rash together with three of the following symptoms: Conjunctivitis, arthralgia, mild-fever or periarticular edema.
3 secondary outcomes
zika virus serology
Time frame: march, 2016 through July 5, 2016
Chikungunya virus serology
Time frame: march, 2016 through July 5, 2016
Dengue virus serology
Time frame: march, 2016 through July 5, 2016
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 23 Feb 2017.
- Derived from this study: PubMed 28877754Santa Rita TH, Barra RB, Peixoto GP, Mesquita PG, Barra GB. Association between suspected Zika virus disease during pregnancy and giving birth to a newborn with congenital microcephaly: a matched case-control study. BMC Res Notes. 2017 Sep 6;10(1):457. doi: 10.1186/s13104-017-2796-1.
- Individual participant dataSharing planned: No
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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.
Gustavo B Barra, ph.D principal investigator
Sabin Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcephaly, run by Laboratório Sabin at 1 site in Brazil.
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 1 inclusion and 1 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Zika virus infection clinical outcomes during pregnancy (time frame: From September 1, 2015 through January 5, 2016). 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 NCT02741882, 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 23 Feb 2017.