NCT04412005

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,958

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 9, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

May 28, 2020

Last Update Submit

June 4, 2020

Conditions

Keywords

malaria

Outcome Measures

Primary Outcomes (1)

  • Number of pregnant women with a P. falciparum infection

    P. falciparum detected by qPCR

    3 years

Secondary Outcomes (2)

  • Number of pregnant women with maternal anemia

    3 years

  • Number of pregnant women delivering a newborn with low birthweight

    3 years

Study Arms (3)

Manhiça

Pregnant women attending the Manhiça District Hospital

Other: No intervention

Ilha Josina

Pregnant women attending the Ilha Josina Health Center

Other: No intervention

Magude

Pregnant women attending the Magude Health Center

Other: No intervention

Interventions

No intervention

Ilha JosinaMagudeManhiça

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBeing pregnant
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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 \[Magude District\])

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots Plasma and PBMCS from a random selection of study participants

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 2, 2020

Study Start

November 1, 2016

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

June 9, 2020

Record last verified: 2020-05