The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.
Who can participate
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Trial 1:
* Permanent resident in the area
* Gestational age at the first antenatal visit ≤ 28 weeks
* Signed informed consent
* Agreement to deliver in the study site's maternity(ies) wards
Trial 2:
* Permanent resident in the area.
* Gestational age at the first antenatal visit ≤ 28 weeks
* HIV seropositive (after voluntary counseling and testing)
* Indication to receive CTX prophylaxis (according to the national guidelines)
* Signed informed consent
* Agreement to deliver in the study site's maternity(ies) wards.
Exclusion Criteria:
Trial 1:
* Residence outside the study area or planning to move out in the following 18 months from enrollment
* Gestational age at the first antenatal visit \> 28 weeks of pregnancy
* Known history of allergy to sulfa drugs or mefloquine
* Known history of severe renal, hepatic, psychiatric or neurological disease
* MQ or halofantrine treatment in the preceding 4 weeks
* HIV infection
* Participating in other studies
Trial 2:
* Residence outside the study area or planning to move out in the following 10 months from enrollment
* Gestational age at the first antenatal visit \> 28 weeks of pregnancy
* Known history of allergy to CTX or MQ
* Known history of severe renal, hepatic, psychiatric or neurological disease
* MQ or halofantrine treatment in the preceding 4 weeks
What they're measuring
1
Trial 1 (IPTp MQ vs IPTp SP): Low birth weight.
Timeframe: day 0, birth
2
Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia.