Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Sulphadoxine-pyrimethamine and Amodiaquine Alone or in Combination as Intermittent Preventive Treatment in Pregnancy in the Kassena-Nankana District of Ghana: a Randomized Controlled Trial
Brief Summary: In areas of stable transmission, pregnant women, especially during the first and second pregnancies, have an increased susceptibility to Plasmodium falciparum malaria, malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of perennial transmission and there is a need to study this effect in intense seasonal transmission settings. The emergence and spread of resistance to SP is likely to undermine its useful lifespan and it is important that other antimalarials that are safe and effective are identified for use in IPTp. The options are however limited. Amodiaquine has been shown to be effective in treatment of clinical cases of malaria, even in areas where chloroquine resistance is prevalent, and its combination with SP has been associated with favourable results. Both are affordable. However, there is limited data on their use in pregnancy. This study aims to assess the efficacy of SP in an area of intense seasonal transmission, and evaluate the safety and efficacy of amodiaquine and a combination of sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.


Options:
A: Inclusion Criteria:

* Her pregnancy is confirmed at 16 to 24 weeks at their first booking.
* She is willing to participate and complete the test schedule, and has given informed consent.
* She is willing to have supervised delivered at maternity units in the district.
* She lives within the study district.

Exclusion Criteria:

* She has a past obstetric and medical history that will adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
* She has a haemoglobin level below 5.0 g/dl.
* She has malaria that is severe enough to require parenteral medication.
B: Inclusion Criteria:

* HIV-positive pregnant women between 16-28 weeks of gestation identified through VCT
* HIV-negative pregnant women between 16-28 weeks of gestation identified through VCT
* Residence within the catchment area of the health facility
* Willing to deliver at the health facility
* Willing to agree to adhere to the requirements of study participation (including monthly ANC visits and willing to allow all study procedures)
* Willing to provide written informed consent
* Aged 18 years and above

Exclusion Criteria:

* Severe anemia (Hb \< 6 g/dL)
* History of allergic reactions to sulfa drugs
* History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section)
* 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 presenting illness that requires hospitalization
* 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
C: Inclusion Criteria:

* Pregnant women whose pregnancies are at \<27 weeks gestation at first antenatal booking
* Permanent resident in study area
* Informed consent

Exclusion Criteria:

* Late presentation: pregnancies more than 26 weeks gestation at first antenatal booking
* Severe anaemia (Hb\<70g/L) on enrolment
* Previous reaction to a sulfa-drug (e.g. sulphadoxine-pyrimethamine, septrin)
* History of severe skin reaction to any drug
* Current (or history) of severe disease (e.g. hepatitis, jaundice, TB, AIDS)

Withdrawal Criteria:

* Withdrawal of consent
* Women developing severe anaemia (Hb\<70g/L)during pregnancy
D: Inclusion Criteria:

* Pregnant women with gestation between 18-32weeks,
* willing to give written consent to take part in the study
* Resident in the study area and available for follow-up.

Exclusion Criteria:

* Presentation with clinical symptoms of malaria (this would not affect subsequent enrollment at a later date),
* Known allergies or reactions to study drugs,
* Medical conditions needing hospital admission.

Answer: D