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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Foundation for Innovative New Diagnostics, Switzerland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Information provided by (Responsible Party):
Heidi Hopkins, Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier:
NCT01555255
First received: March 14, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition
Malaria
Placental Malaria
Malaria in Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria

Resource links provided by NLM:


Further study details as provided by Foundation for Innovative New Diagnostics, Switzerland:

Primary Outcome Measures:
  • accuracy of diagnostic tests during gestation [ Time Frame: 2nd trimester of pregnancy ] [ Designated as safety issue: No ]
    accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation

  • accuracy of diagnostic tests during gestation [ Time Frame: 3rd trimester of pregnancy ] [ Designated as safety issue: No ]
    accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation


Secondary Outcome Measures:
  • association of placental malaria with infant birth weight [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • association of placental malaria with maternal hemoglobin [ Time Frame: twice during gestation and at delivery ] [ Designated as safety issue: No ]
  • accuracy of diagnostic tests at delivery [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    accuracy of malaria RDTs, peripheral blood smears and PCR performed on maternal peripheral blood to diagnose placental malaria at delivery


Biospecimen Retention:   Samples With DNA

Red cell pellets, dried whole blood on filter paper, and fixed blood and placental tissue


Estimated Enrollment: 1205
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   16 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555255

Locations
Burkina Faso
IRSS, Direction Régionale de l'Ouest
Bobo-Dioulasso, Burkina Faso, 01BP 545
Uganda
Tororo District Hospital
Tororo, Tororo District, Uganda, 0
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
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
  More Information

No publications provided by Foundation for Innovative New Diagnostics, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heidi Hopkins, Principal Investigator, Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT01555255     History of Changes
Other Study ID Numbers: RPC390
Study First Received: March 14, 2012
Last Updated: October 2, 2012
Health Authority: Burkina Faso: Centre Muraz, Comite d'Ethique, Ministere de la Sante
Uganda: National Council for Science & Technology (UNCST)

Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
malaria
pregnancy
placental malaria
malaria in pregnancy
birth weight
anemia

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 23, 2014