Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria

April 22, 2015 updated by: Foundation for Innovative New Diagnostics, Switzerland
This study seeks to determine whether screening pregnant women for malaria with malaria rapid diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth outcomes due to malaria in areas of varied malaria transmission in Africa.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Malaria prevention measures for pregnant women are critical and available, but the effectiveness of intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine, a cornerstone in this prevention effort, is declining with increasing parasite resistance. New drugs for IPTp are being considered, but there are disadvantages to presumptive use of the few remaining efficacious antimalarials. An alternative approach may involve screening with diagnostic tests to better target efficacious antimalarial treatment to asymptomatic women with laboratory evidence of malaria infection. Light microscopy of peripheral maternal blood misses a large proportion of cases, and PCR is unavailable in routine health care settings. Preliminary evidence suggests that detection of parasite antigen in peripheral blood may provide an accurate indicator of clinically significant infections and predict pregnancy outcomes. Therefore, screening with RDTs may offer an accurate and practical way to identify pregnant women who will benefit from targeted therapy for placental malaria infection. Antigen detection thresholds vary widely among RDTs, and the distribution of target antigens in peripheral blood circulation is expected to differ; therefore, the potential value of RDTs in this population can best be established by evaluating the detection of placental parasitemia for highly-characterized RDTs, enabling results to be extrapolated to other products and programs. The study described here is proposed to address this question.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Bobo-Dioulasso, Burkina Faso, 01BP 545
        • IRSS, Direction Régionale de l'Ouest
  • Uganda
    • Tororo District
      • Tororo, Tororo District, Uganda
        • Tororo District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 44 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women presenting for routine antenatal care in the second and third trimesters of pregnancy, at antenatal clinics at ≥2 sites of varied malaria transmission intensity in Africa

Description

Specific participant selection criteria include:

  1. Presenting for care after quickening and before onset of labor (i.e. in the second or third trimester of pregnancy)
  2. Age between 16 years and 44 years, inclusive
  3. Willingness and ability to follow up with study visits and activities through the duration of pregnancy and at delivery
  4. Absence of history of serious adverse reaction to sulfa drugs
  5. Absence of history of serious adverse reaction to artemisinin-based drugs (depending on national policy on treatment of malaria in pregnancy)
  6. Absence of HIV infection (both because guidelines for malaria prevention in pregnancy for HIV-infected women differ from those for HIV-negative women, and in order to avoid confounding of pregnancy outcomes by HIV-related complications or treatments in this early evaluation)
  7. Absence of history of or current obstetrical complications (e.g. pre-eclampsia, eclampsia, hypertension during pregnancy, post-partum hemorrhage, evidence of multiple gestation)
  8. Absence of chronic disease (e.g. diabetes mellitus, sickle cell disease)
  9. Absence of evidence of severe acute disease requiring inpatient management or referral
  10. Provision of written informed consent
  11. Enrollment Hb ≥7 g/dL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
accuracy of diagnostic tests during gestation
Time Frame: 2nd trimester of pregnancy
accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation
2nd trimester of pregnancy
accuracy of diagnostic tests during gestation
Time Frame: 3rd trimester of pregnancy
accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation
3rd trimester of pregnancy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
association of placental malaria with infant birth weight
Time Frame: at birth
at birth
association of placental malaria with maternal hemoglobin
Time Frame: twice during gestation and at delivery
twice during gestation and at delivery
accuracy of diagnostic tests at delivery
Time Frame: at delivery
accuracy of malaria RDTs, peripheral blood smears and PCR performed on maternal peripheral blood to diagnose placental malaria at delivery
at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation for Innovative New Diagnostics, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Health Organization
World Bank
UNICEF
United Nations Development Programme

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heidi A Hopkins, MD, Foundation for Innovative New Diagnostics, Kampala, Uganda
  • Principal Investigator: Jean-Bosco Ouedraogo, MD, PhD, IRSS, Direction Regionale de l'Ouest, Bobo-Dioulasso, Burkina Faso
  • Study Director: David Bell, MBBS, PhD, Foundation for Innovative New Diagnostics, Geneva, Switzerland
  • Study Director: Jane Cunningham, MD, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland
  • Principal Investigator: Miriam Nakalembe, MBChB, Makerere University Faculty of Medicine, Kampala, Uganda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RPC390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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