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

NCT01555255 | Unknown

• 1 other identifier: RPC390
• Study Type: observational
• Target: 1,205
• Locations: 2 countries
• Sites: 2

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.

Conditions

Malaria; Placental Malaria; Malaria in Pregnancy

Keywords

malaria; pregnancy; placental malaria; malaria in pregnancy; birth weight; anemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

  at delivery

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• UNICEF: collaborator
• United Nations Development Programme: collaborator
• World Bank: collaborator
• World Health Organization: collaborator

Study Sites (2)

IRSS, Direction Régionale de l'Ouest

Bobo-Dioulasso, 01BP 545, Burkina Faso

Location

Tororo District Hospital

Tororo, Tororo District, 0, Uganda

Location

Related Publications (1)

• 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.

  PMID: 24206649 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Malaria; Birth Weight; Anemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

• Miriam Nakalembe, MBChB

  Makerere University Faculty of Medicine, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 15, 2012
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 23, 2015

Record last verified: 2012-10

Locations

BU (1); UG (1)