Clinical trial NCT01555255: Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria
Official title: Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malaria
Placental Malaria
Malaria in Pregnancy
Keywords: malaria
pregnancy
placental malaria
malaria in pregnancy
birth weight
anemia
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: UNICEF
name: United Nations Development Programme
name: World Bank
name: World Health Organization
First posted: 2012-03-15
Enrollment: 1205
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: accuracy of diagnostic tests during gestation
timeFrame: 2nd trimester of pregnancy
measure: accuracy of diagnostic tests during gestation
timeFrame: 3rd trimester of pregnancy
Secondary outcomes:
measure: association of placental malaria with infant birth weight
timeFrame: at birth
measure: association of placental malaria with maternal hemoglobin
timeFrame: twice during gestation and at delivery
measure: accuracy of diagnostic tests at delivery
timeFrame: at delivery
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: IRSS, Direction Régionale de l'Ouest
city: Tororo
country: Uganda
facility: Tororo District Hospital
state: Tororo District
Study officials:
affiliation: Foundation for Innovative New Diagnostics, Kampala, Uganda
name: Heidi A Hopkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRSS, Direction Regionale de l'Ouest, Bobo-Dioulasso, Burkina Faso
name: Jean-Bosco Ouedraogo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland
name: David Bell, MBBS, PhD
role: STUDY_DIRECTOR
affiliation: UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland
name: Jane Cunningham, MD
role: STUDY_DIRECTOR
affiliation: Makerere University Faculty of Medicine, Kampala, Uganda
name: Miriam Nakalembe, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.