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

NCT ID: NCT01555255

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-12-31

Brief Summary

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.

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.

Conditions

Malaria; Placental Malaria; Malaria in Pregnancy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNICEF

OTHER

Sponsor Role: collaborator

United Nations Development Programme

UNKNOWN

Sponsor Role: collaborator

World Bank

OTHER

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heidi A Hopkins, MD

Role: PRINCIPAL_INVESTIGATOR

Foundation for Innovative New Diagnostics, Kampala, Uganda

Jean-Bosco Ouedraogo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRSS, Direction Regionale de l'Ouest, Bobo-Dioulasso, Burkina Faso

David Bell, MBBS, PhD

Role: STUDY_DIRECTOR

Foundation for Innovative New Diagnostics, Geneva, Switzerland

Jane Cunningham, MD

Role: STUDY_DIRECTOR

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland

Miriam Nakalembe, MBChB

Role: PRINCIPAL_INVESTIGATOR

Makerere University Faculty of Medicine, Kampala, Uganda

Locations

IRSS, Direction Régionale de l'Ouest

Bobo-Dioulasso, , Burkina Faso

Tororo District Hospital

Tororo, Tororo District, Uganda

Countries

Burkina Faso; Uganda

References

Canier L, Khim N, Kim S, Sluydts V, Heng S, Dourng D, Eam R, Chy S, Khean C, Loch K, Ken M, Lim H, Siv S, Tho S, Masse-Navette P, Gryseels C, Uk S, Van Roey K, Grietens KP, Sokny M, Thavrin B, Chuor CM, Deubel V, Durnez L, Coosemans M, Menard D. An innovative tool for moving malaria PCR detection of parasite reservoir into the field. Malar J. 2013 Nov 9;12:405. doi: 10.1186/1475-2875-12-405.

Reference Type: DERIVED

PMID: 24206649 (View on PubMed)

Other Identifiers

RPC390

Identifier Type: -

Identifier Source: org_study_id