P. FalciparumMiPMonNCT04412005
Pregnant Women for Malaria Surveillance
An observational study of P. Falciparum, run by Barcelona Institute for Global Health.
Trial summary
Close monitoring of malaria in pregnancy can help to quickly identify changes in malaria burden and related adverse outcomes, especially in areas embarking in malaria elimination activities. 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
- P. Falciparum
- How many people
- 16,958 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 31 Oct 2019
- 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: Pregnant women attending three health centers in areas of Maputo Province with different levels of malaria transmission (Manhiça District Hospital [Manhiça District], Ilha Josina Health Center [Manhiça District] and Magude Health Center [Magude District])
Who may be able to join
- Pregnant women attending their first routine ANCs or pregnant women seen at the moment of delivery or pregnant women with signs/symptoms of malaria (axillary temperature ≥ 37.5°C, referred history of fever in the last 24 hours, pallor, arthromyalgias, headache and/or history of convulsions)
- Being equal or older than 16 years
- Being from the study area
Who cannot join
- Unwillingness to participate in the study or to have samples obtained
- Not being from the study area.
About this study
Official title: Pregnant Women as a Sentinel Group for Malaria Surveillance in an Era of Changing Malaria Transmission
Close monitoring of malaria in pregnancy can help to quickly identify changes in malaria burden and related adverse outcomes, especially in areas embarking in malaria elimination activities. The easy access of pregnant women through antenatal clinics, combined with the potential of pregnancy-specific serology to assess cumulative exposure to malaria, can provide the basis for new sentinel surveillance methods. Such an approach has the potential to guide clinical practice and the choice of malaria control/preventive tools adapted to areas of different transmission intensity, as well as to generate sensitive metrics of transmission during malaria elimination activities.
Read the detailed description
Continued monitoring of malaria in pregnancy is lacking in most endemic settings, in spite of its significant disease burden. Increases in malaria-related harmful effects observed among Mozambican pregnant women after drastic malaria declines during the last decade [2] suggest that closely monitoring of the transmission is needed to quickly identify rebounds in adverse outcomes, especially in areas embarking in malaria elimination activities. Moreover, several evidences point to IgGs against VAR2CSA (the parasite antigen that mediates sequestration of P. falciparum in the placenta) as a marker of cumulative exposure to P. falciparum during pregnancy that can provide estimates of malaria transmission. The investigators hypothesize that dynamics of malaria in pregnancy and pregnancy-specific immunity reflect changes in the intensity of transmission through location and time, not only among pregnant women but also in the underlying community. The goal of this study is to provide epidemiological, molecular and immunological insights of the value of pregnant women attending health facilities to generate estimates of malaria burden and its adverse consequences in situation of varying levels of malaria transmission, with the ultimate hope of developing new tools for the monitoring of malaria in endemic countries. To address this, the investigators will conduct a three-year prospective observational study at three health facilities with different levels of malaria transmission in Maputo Province to determine the relationship between malaria transmission, parasitological outcomes and the clinical impact of malaria infection in pregnant women at their first antenatal visit, delivery and during sick visits (Aim 1.1). Moreover, the investigators will create a sample repository biobank for future investigations on host and parasite factors influencing malaria disease during pregnancy (Aim 1.2). The investigators will also determine the relationship between malaria estimates obtained from pregnant women, children at hospital visits, (Aim 2.1) and seroprevalences against VAR2CSA (Aim 2.2). The impact of interrupting malaria transmission on pregnancy-specific serology (Aim 2.3) will be assessed in pregnant women from Magude after mass drug administration in the community. Finally, scientific capacity in the Manhiça Health Research Center (Aim 3) will be developed through training on a) epidemiological research and management of malaria data; b) molecular tools for detection of malaria parasites and molecular markers of antimalarial resistance for rapid mapping of drug resistance; and c) pregnancy-specific immunity as an innovative tool to assess malaria transmission. This study will contribute to promote a pregnancy malaria research agenda by improving our scientific knowledge on determinants of malaria susceptibility during pregnancy and demonstrating the feasibility and value of an easy-to-implement new generation serological tool for malaria surveillance in malaria elimination contexts.
- Conditions
- P. Falciparum
- Being tested
- No intervention
- Keywords
- malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Manhiça | Pregnant women attending the Manhiça District Hospital Receives: Other: No intervention | |
| Ilha Josina | Pregnant women attending the Ilha Josina Health Center Receives: Other: No intervention | |
| Magude | Pregnant women attending the Magude Health Center Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pregnant women with a P. falciparum infection
- falciparum detected by qPCR
Measured: 3 years
Secondary outcomes (2)
Number of pregnant women with maternal anemia
Hemoglobin levels (Hemocue)
Measured: 3 years
Number of pregnant women delivering a newborn with low birthweight
grams in a digital scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Nov 2016
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for P. FalciparumStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 16,958 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412005
- Sponsor's protocol ID
- 1R01AI123050
- Acronym
- MiPMon
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant Women as a Sentinel Group for Malaria Surveillance in an Era of Changing Malaria Transmission
- ClinicalTrials.gov ID
- NCT04412005
- Acronym / sponsor ID
- MiPMon / 1R01AI123050
- Conditions
- P. Falciparum
- Keywords
- malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,958 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 2 Jun 2020 (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.
Close monitoring of malaria in pregnancy can help to quickly identify changes in malaria burden and related adverse outcomes, especially in areas embarking in malaria elimination activities. The easy access of pregnant women through antenatal clinics, combined with the potential of pregnancy-specific serology to assess cumulative exposure to malaria, can provide the basis for new sentinel surveillance methods. Such an approach has the potential to guide clinical practice and the choice of malaria control/preventive tools adapted to areas of different transmission intensity, as well as to generate sensitive metrics of transmission during malaria elimination activities.
Detailed description
Continued monitoring of malaria in pregnancy is lacking in most endemic settings, in spite of its significant disease burden. Increases in malaria-related harmful effects observed among Mozambican pregnant women after drastic malaria declines during the last decade [2] suggest that closely monitoring of the transmission is needed to quickly identify rebounds in adverse outcomes, especially in areas embarking in malaria elimination activities. Moreover, several evidences point to IgGs against VAR2CSA (the parasite antigen that mediates sequestration of P. falciparum in the placenta) as a marker of cumulative exposure to P. falciparum during pregnancy that can provide estimates of malaria transmission. The investigators hypothesize that dynamics of malaria in pregnancy and pregnancy-specific immunity reflect changes in the intensity of transmission through location and time, not only among pregnant women but also in the underlying community. The goal of this study is to provide epidemiological, molecular and immunological insights of the value of pregnant women attending health facilities to generate estimates of malaria burden and its adverse consequences in situation of varying levels of malaria transmission, with the ultimate hope of developing new tools for the monitoring of malaria in endemic countries. To address this, the investigators will conduct a three-year prospective observational study at three health facilities with different levels of malaria transmission in Maputo Province to determine the relationship between malaria transmission, parasitological outcomes and the clinical impact of malaria infection in pregnant women at their first antenatal visit, delivery and during sick visits (Aim 1.1). Moreover, the investigators will create a sample repository biobank for future investigations on host and parasite factors influencing malaria disease during pregnancy (Aim 1.2). The investigators will also determine the relationship between malaria estimates obtained from pregnant women, children at hospital visits, (Aim 2.1) and seroprevalences against VAR2CSA (Aim 2.2). The impact of interrupting malaria transmission on pregnancy-specific serology (Aim 2.3) will be assessed in pregnant women from Magude after mass drug administration in the community. Finally, scientific capacity in the Manhiça Health Research Center (Aim 3) will be developed through training on a) epidemiological research and management of malaria data; b) molecular tools for detection of malaria parasites and molecular markers of antimalarial resistance for rapid mapping of drug resistance; and c) pregnancy-specific immunity as an innovative tool to assess malaria transmission. This study will contribute to promote a pregnancy malaria research agenda by improving our scientific knowledge on determinants of malaria susceptibility during pregnancy and demonstrating the feasibility and value of an easy-to-implement new generation serological tool for malaria surveillance in malaria elimination contexts.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manhiça | – | Other: No interventionPregnant women attending the Manhiça District Hospital |
| Ilha Josina | – | Other: No interventionPregnant women attending the Ilha Josina Health Center |
| Magude | – | Other: No interventionPregnant women attending the Magude Health Center |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women attending three health centers in areas of Maputo Province with different levels of malaria transmission (Manhiça District Hospital [Manhiça District], Ilha Josina Health Center [Manhiça District] and Magude Health Center [Magude District])
Key inclusion criteria (3 listed)
- Pregnant women attending their first routine ANCs or pregnant women seen at the moment of delivery or pregnant women with signs/symptoms of malaria (axillary temperature ≥ 37.5°C, referred history of fever in the last 24 hours, pallor, arthromyalgias, headache and/or history of convulsions)
- Being equal or older than 16 years
- Being from the study area
Key exclusion criteria (2 listed)
- Unwillingness to participate in the study or to have samples obtained
- Not being from the study area.
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 |
|---|---|---|
| No interventionNo intervention | Other | Ilha Josina, Magude, Manhiça |
Primary outcome
Number of pregnant women with a P. falciparum infection
Time frame: 3 years
P. falciparum detected by qPCR
2 secondary outcomes
Number of pregnant women with maternal anemia
Time frame: 3 years
Number of pregnant women delivering a newborn with low birthweight
Time frame: 3 years
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 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of P. Falciparum, run by Barcelona Institute for Global Health.
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 2 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of pregnant women with a P. falciparum infection (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.