Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment During Pregnancy in Benin: a Randomized, Open, and Equivalent Trial Comparing Sulfadoxine-Pyrimethamine With Mefloquine
Brief Summary: Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria control during pregnancy in Benin, but the emergence and the spread of resistance to SP justifies the evaluation of alternative anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to SP. The aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum becomes too elevated. Primary endpoint will be the proportion of infants with low birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.


Options:
A: Inclusion Criteria:

* Less than 28 weeks of pregnancy

Exclusion Criteria:

* Previous allergic reactions to sulphonamides
B: Inclusion Criteria:

* Gestation of at least 16 weeks and \<37 weeks;
* P. falciparum monoinfection of any density, with or without symptoms
* Hb equal or higher than 7 g/dL;
* At least 15 years old;
* Residence within the health facility catchment's area;
* Willing to deliver at the health facility;
* Willing to adhere to study requirements (including in Zambia and Malawi, HIV VCT)
* Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, the investigator is responsible to check that the woman herself is also freely willing to take part in the study, and the woman will be asked to sign for "assent").

Exclusion Criteria:

* History of allergic reactions to the study drugs;
* History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
* History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
* Current cotrimoxazole prophylaxis or ARV treatment;
* Any significant illness at the time of screening that requires hospitalization, including severe malaria;
* Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
* Prior enrollment in the study or concurrent enrollment in another study.
* Unable to take oral medication
* Clear evidence of recent (1 week) treatment with antimalarials or antimicrobials with antimalarial activity (clindamycin; azythromycin; etc.)
C: 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
D: Inclusion Criteria:

* Pregnancy between 16 and 28 weeks of gestation
* Residence near the maternity clinics
* Intention to continue the ante-natal care and deliver at the study maternity clinic
* Ability to take drugs by oral route
* Written informed consent (parents or guardian if aged \< 18 years)

Exclusion Criteria:

* Pregnancy prior to 16 weeks or after 28 weeks of gestation
* Previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine
* History of neurological or psychiatric event
* Intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment
* Current treatment with halofantrine

Answer: D