Daily Co-trimoxazole Prophylaxis to Prevent Malaria in Pregnancy

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women and children are the most vulnerable population. Malaria in pregnancy increases the risks of abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia are recommended.

HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV infected persons, and CTX prophylaxis significantly improves birth outcomes in immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we aim to establish the safety and efficacy of daily CTX in preventing malaria infection during pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This information is urgently needed to assist to issue guidelines on IPT in pregnancy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Tropical Medicine, Belgium
• Collaborator: Tropical Diseases Research Centre, Zambia
• Treatments: Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Confirmed pregnancy (through palpable fundus and/ or positive pregnancy test)

• Gestational age between 16 and 28 weeks.

• Informed consent by patient (or parent/ guardian if patient is less than 18 years of age)

• No symptoms consistent with malaria

• Willingness to deliver at the health facility

• Willingness to adhere to all requirements of the study (including HIV-1 testing)

Exclusion Criteria:

• History of allergy to study drugs, or previous history of allergy to sulpha drugs

• 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 illness that requires hospitalization;

• Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;

• Prior enrolment in the study or concurrent enrolment in another study

• Severe anaemia (Hb<7 g/dl)

• Previous history of unfavourable pregnancy outcome: pre-eclampsia, caesarean section, stillbirth.

• Being HIV infected and already receiving CTX prophylaxis or ARV treatment