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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00270530
Other study ID # S1954-21/22-2
Secondary ID
Status Completed
Phase Phase 4
First received December 23, 2005
Last updated January 30, 2006
Start date November 2002
Est. completion date October 2004

Study information

Verified date November 2004
Source Center for International Health and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.


Description:

Primary Objectives

To compare the efficacy of IPT with monthly SP versus a two-dose regimen given once in the second and once in the third trimester in HIV-infected women on the:

- Prevalence of placental malaria infection

- Prevalence of maternal peripheral parasitemia

Secondary objectives

To compare IPT with monthly SP versus a two-dose regimen given once in the second and once in the third trimester in HIV-infected women on:

- Birth weight, including the proportion of LBW infants

- Incidence of prematurity

- Neonatal and fetal death and third trimester stillbirth

- Incidence of neonatal jaundice

- Third trimester anemia

- Third trimester severe anemia

- Proportion of mothers who develop symptomatic malaria during the course of pregnancy


Recruitment information / eligibility

Status Completed
Enrollment 454
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- HIV-positive pregnant women between 16-28 weeks of gestation identified through VCT

- HIV-negative pregnant women between 16-28 weeks of gestation identified through VCT

- Residence within the catchment area of the health facility

- Willing to deliver at the health facility

- Willing to agree to adhere to the requirements of study participation (including monthly ANC visits and willing to allow all study procedures)

- Willing to provide written informed consent

- Aged 18 years and above

Exclusion Criteria:

- Severe anemia (Hb < 6 g/dL)

- History of allergic reactions to sulfa drugs

- History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section)

- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization

- Any significant presenting illness that requires hospitalization

- Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area

- Prior enrollment in the study or concurrent enrollment in another study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Sulfadoxine-pyrimethamine (Fansidar)


Locations

Country Name City State
Zambia Tropical Diseases Research Centre Ndola

Sponsors (2)

Lead Sponsor Collaborator
Center for International Health and Development Centers for Disease Control and Prevention

Country where clinical trial is conducted

Zambia, 

Outcome

Type Measure Description Time frame Safety issue
Primary • Prevalence of placental malaria infection
Primary • Prevalence of maternal peripheral parasitemia
Secondary • Prevalence of maternal peripheral parasitemia
Secondary • Birth weight, including the proportion of LBW infants
Secondary • Incidence of prematurity
Secondary • Neonatal and fetal death and third trimester stillbirth
Secondary • Incidence of neonatal jaundice
Secondary • Third trimester anemia
Secondary • Third trimester severe anemia
Secondary • Proportion of mothers who develop symptomatic malaria during the course of pregnancy
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