Collection of Biological Material From Pregnant Women in a Malarial Region

NCT01862783 | Terminated

• 2 other identifiers: 99991307413-I-N074
• Study Type: observational
• Target: 1,270
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Malaria is a disease caused by a parasite that infects the blood. It affects millions of people every year and frequently harms or kills pregnant woman and infants. Researchers are looking for treatments that may help pregnant women in areas of the world where malaria is common. To do so, they want to collect blood and other samples from pregnant women in south-central Uganda. They will also collect samples from newborn babies if the mother agrees to it. Objectives: \- To collect biological material such as blood samples from pregnant women and newborns. Eligibility:

• Women between 14 and 45 years of age who are pregnant or are in labor.
• Participants will be from the Kalisizio area of south-central Uganda. Design:
• Women who are pregnant will provide blood and urine samples.
• Women who are in labor will allow researchers to collect samples from their baby after the delivery. Samples will be taken of placenta tissue and umbilical cord blood. The baby will also be weighed and measured. Researchers will look at the baby's physical appearance and muscle strength.
• Treatment will not be offered as part of this study.

Conditions

Malaria

Keywords

Erythrocytes; Parasites; Plasmodium Falciparum; Placenta; Resistant

Outcome Measures

Primary Outcomes (1)

• Samples collected from the women will be used in in-vitro assays to assess the functional activity of antisera raised against pregnancy malaria vaccine candidates as the primary outcome of this study.

  ongoing

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A study participant must satisfy the following criteria to be enrolled in this study:
• Pregnant women aged 14-45 years or newborns of pregnant women enrolled at parturition
• Able to provide consent for self and newborn (if enrolled at parturition)

You may not qualify if:

• Clinically symptomatic or apparent severe anemia, active bleeding, or any other condition that may be worsened by 10 mL phlebotomy or any other study procedure
• History of involvement in a malaria vaccine study

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Kalisizo Hospital

Rakai District, Uganda

Location

Related Publications (3)

• Brabin BJ, Hakimi M, Pelletier D. An analysis of anemia and pregnancy-related maternal mortality. J Nutr. 2001 Feb;131(2S-2):604S-614S; discussion 614S-615S. doi: 10.1093/jn/131.2.604S.

  PMID: 11160593 BACKGROUND

• Buffet PA, Gamain B, Scheidig C, Baruch D, Smith JD, Hernandez-Rivas R, Pouvelle B, Oishi S, Fujii N, Fusai T, Parzy D, Miller LH, Gysin J, Scherf A. Plasmodium falciparum domain mediating adhesion to chondroitin sulfate A: a receptor for human placental infection. Proc Natl Acad Sci U S A. 1999 Oct 26;96(22):12743-8. doi: 10.1073/pnas.96.22.12743.

  PMID: 10535993 BACKGROUND

• Duffy MF, Maier AG, Byrne TJ, Marty AJ, Elliott SR, O'Neill MT, Payne PD, Rogerson SJ, Cowman AF, Crabb BS, Brown GV. VAR2CSA is the principal ligand for chondroitin sulfate A in two allogeneic isolates of Plasmodium falciparum. Mol Biochem Parasitol. 2006 Aug;148(2):117-24. doi: 10.1016/j.molbiopara.2006.03.006. Epub 2006 Apr 7.

  PMID: 16631964 BACKGROUND

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Michal Fried, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 24, 2013
• Study Start: February 10, 2013
• Primary Completion: October 19, 2015
• Study Completion: March 15, 2016
• Last Updated: November 25, 2019

Record last verified: 2016-03-15

Locations

UG (1)