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

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: Unknown
• Conditions: Malaria; Malaria in Pregnancy; Placental Malaria

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: Observational
• Enrollment (Anticipated): 1205

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of diagnostic tests during gestation	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	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

Outcome Measure	Measure Description	Time Frame
association of placental malaria with infant birth weight		at birth
association of placental malaria with maternal hemoglobin		twice during gestation and at delivery
accuracy of diagnostic tests 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

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Collaborators: World Health Organization; World Bank; UNICEF; United Nations Development Programme
• Investigators: 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

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: anemia; pregnancy; malaria; birth weight; malaria in pregnancy; placental malaria
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: RPC390