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Pregnant Women for Malaria Surveillance

Pregnant Women as a Sentinel Group for Malaria Surveillance in an Era of Changing Malaria Transmission

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04412005
Acronym
MiPMon
Enrollment
16958
Registered
2020-06-02
Start date
2016-11-01
Completion date
2019-10-31
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P. Falciparum

Keywords

malaria

Brief 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. 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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Barcelona Institute for Global Health
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Unwillingness to participate in the study or to have samples obtained * Not being from the study area.

Design outcomes

Primary

MeasureTime frameDescription
Number of pregnant women with a P. falciparum infection3 yearsP. falciparum detected by qPCR

Secondary

MeasureTime frameDescription
Number of pregnant women with maternal anemia3 yearsHemoglobin levels (Hemocue)
Number of pregnant women delivering a newborn with low birthweight3 yearsgrams in a digital scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026