Clinical trial NCT04412005: Pregnant Women for Malaria Surveillance
Official title: Pregnant Women as a Sentinel Group for Malaria Surveillance in an Era of Changing Malaria Transmission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: P. Falciparum
Keywords: malaria
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 16958
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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 \[Magude District\])

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of pregnant women with a P. falciparum infection
timeFrame: 3 years
Secondary outcomes:
measure: Number of pregnant women with maternal anemia
timeFrame: 3 years
measure: Number of pregnant women delivering a newborn with low birthweight
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: