EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY

• Register: PACTR
• Last refreshed on: 27 May 2013
• Main ID: PACTR2010020001429343
• Date of registration: 27/05/2009
• Primary sponsor: FCRB
• Public title: EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY
• Scientific title: EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010020001429343
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation using a radomisation table created by a computer software program ,; Sealed opaque envelopes ,

Countries of recruitment

South Africa

Contacts

• Name: Golbahar Pahlavan
• Affiliation: Project manager

• Name: Raquel Gonzalez
• Affiliation: Research Fellow

Key inclusion & exclusion criteria

Inclusion criteria: 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 wards


Exclusion criteria:
Residence outside the study area or planning to move out in the following 18 months from enrollment
Gestational age at the first antenatal visit b 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



Age minimum: 15 Year
Age maximum: 50 Year
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

Prevalence of low borth weight (`2500 kg)

Secondary Outcome(s)

Frequency of congenital malformations

Frequency of drug adverse reactions

Incidence of clinical malaria

Incidence of dizziness

Incidence of malaria during the first year of life

Incidence of overall admissiojns/outpatient attendances

Incidence of vomiting

Mean birth weight

Mean gestational age

Mean maternal hemoglobin rate

Neonatal and infant mortality rate

Number of miscarriages

Number of stillbirths

Peripheral maternal parasitaemia

Prevalence of congenital malaria

Prevalence of fetal anaemia

Prevalence of moderate maternal anaemia at delivery

Prevalence of P.falciparum in cord blood

Prevalence of placental P. falciparum infection

Prevalence of prematurity

Prevalence of severe maternal anaemia at delivery

Source(s) of Monetary Support

EDCTP

Malaria in Pregnancy Consortium_LSTM