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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01555255
• Other study ID #: RPC390
• Status: Active, not recruiting
• Phase: N/A
• First received: March 14, 2012
• Last updated: April 22, 2015
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Centre Muraz, Comite d'Ethique, Ministere de la SanteUganda: National Council for Science & Technology (UNCST)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1205
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 44 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Malaria in Pregnancy
• Placental Malaria

Locations

Country	Name	City	State
Burkina Faso	IRSS, Direction Régionale de l'Ouest	Bobo-Dioulasso
Uganda	Tororo District Hospital	Tororo	Tororo District

Sponsors (5)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	UNICEF, United Nations Development Programme, World Bank, World Health Organization

Countries where clinical trial is conducted

Burkina Faso,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	association of placental malaria with infant birth weight		at birth	No
Secondary	association of placental malaria with maternal hemoglobin		twice during gestation and at delivery	No
Secondary	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	No