Status:
TERMINATED
Daily Co-trimoxazole Prophylaxis to Prevent Malaria in Pregnancy
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Tropical Diseases Research Centre, Zambia
Conditions:
Malaria in Pregnancy
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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, premat...
Detailed Description
Malaria is a major contributor of disease burden in Sub-Saharan Africa, with pregnant women and children being the most vulnerable population. P. falciparum infection in pregnancy leads to parasite se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00711906
Start Date
February 1 2009
End Date
September 1 2010
Last Update
January 18 2016
Active Locations (2)
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1
Choma hospital
Choma, Zambia
2
Shampande Clinic
Shampande, Zambia