Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda (SP IPTp)

University of California San Francisco (UCSF)

Status and phase: Withdrawn; Phase 4

Conditions: Placental Malaria; Intermittent Preventive Treatment

Treatments: Drug: Sulfadoxine-pyrimethamine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01184911

CDC5972

Details and patient eligibility

About

The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• 16-26 weeks gestation based on LMP or ultrasound or fundal height
• Axillary temperature <37.5 degrees C
• Informed consent
• HIV status known and negative
• Blood smear positive for falciparum malaria

Exclusion criteria

• History of hypersensitivity reaction to SP or components of SP

• Axillary temperature ≥37.5 degrees C

• History of receipt of antimalarials or antibiotics with antimalarial activity* in the past month

• Residence > 30 km from the ANC clinic or unwillingness to return for follow-up visits

• Hemoglobin level < 5 gm/dL

  • These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

SP

Experimental group

Description:

Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria

Treatment:

Drug: Sulfadoxine-pyrimethamine