Malarial Immunity in Pregnant Cameroonian Women

NCT00593398 | Completed

• 1 other identifier: 07-0010
• Study Type: observational
• Target: 990
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria is caused by a parasite and is a health problem for mothers and fetuses (unborn infants). The Cameroonian Ministry of Health recommends that all pregnant women should take the drug sulfadoxine-pyrimethamine (also known as SP) every two months during pregnancy to avoid malaria. The purpose of this study is to find out how effective SP is in preventing pregnant Cameroonian women from getting malaria. Additional goals of this study are to see whether: SP prevents malaria parasites from causing changes in the placenta; SP prevents or helps women make a substance that keeps parasites from accumulating in the placenta; and whether SP affects the amount of protection a mother transfers to her baby. Participants will include 1,160 pregnant women, ages 15-50 years, and 216 babies born residing in Ngalii II and Ntouessong. Study procedures will include monthly blood samples from pregnant women and babies. Volunteers may participate in this study for up to 19 months.

Conditions

Plasmodium Falciparum Malaria

Keywords

Malaria; pregnant women; infants; Cameroon

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cameroonian women who are pregnant and living in the city of Yaounde or the village of Ngali II and Ntouessong in Soa district

You may qualify if:

• Pregnant women who will be followed longitudinally during pregnancy:
• Greater than or equal to 15 years of age.
• Willingness to provide informed consent.
• Confirmed pregnancy.
• All gestational ages. Women less than 16 weeks of pregnancy will be enrolled, but they will not receive intermittent preventive therapy using sulfadoxine plus pyrimethamine (IPT-SP) until the 16th week of pregnancy or thereafter.
• Long-term residence in Yaounde, Ngali II or Ntouessong.
• Willingness of a women residing in Yaounde to release HIV testing results, obtained through a service provided by the MOH, to Dr. Leke, Cam-PI.
• Women residing in Ngalii II and Ntouessong will be encouraged to be HIV tested and asked to provide data on their HIV status to the project. However, HIV testing and providing the results will be optional.
• Pregnant women enrolled near term:
• Same as above.
• Women who have a health booklet with entries entered by a physician/midwife/pharmacist about antimalarial treatment they have received during pregnancy
• Resident of Ngali II or Ntouessong.
• Willingness of the mother/caregivers to give informed consent for their babies.
• Agree to bring the baby to the clinic whenever s/he becomes ill. Alternatively, inform the designated staff member or village health care worker that the baby is ill.
• Willingness to bring the baby for all recommended routine child-hood immunizations.

You may not qualify if:

• Pregnant Cameroonian women following longitudinally during pregnancy:
• Women who report a history of allergic reactions to sulfamides
• Women who report reactions to previously unknown antimalarial drugs
• Women with serious liver attacks (e.g., chronic hepatitis) or kidney failure or neurological conditions (e.g., seizures).
• Women with history of skin allergies
• Other conditions that in the opinion of the Director of Clinical Studies (DCS) or clinical staff (CS) would jeopardize the safety and rights of a participant in the trial or would render the participant unable to comply with the protocol.
• Pregnant women enrolled near term:
• None.
• Infants living in Ngali II and Ntouessong:
• Vague or incomplete information on maternal use of anti-malarials during pregnancy.
• Failure to inform the project staff that they are about to, or have delivered their babies, thereby preventing access to baseline information and specimens at birth that are critical for conduct of the study.
• Other conditions that in the opinion of the DCS, CS, or Cam-PI would jeopardize the safety and rights of a participant in the trial or would render the participant unable to comply with the protocol.

Sponsors & Collaborators

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

Study Sites (1)

University of Yaounde 1

Yaoundé, Cameroon

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples and biopsies of placental tissue

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Diane W Taylor, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

CA (1)