Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
Brief Summary: In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.


Options:
A: Inclusion Criteria:

* First or second pregnancy
* Greater than 16 weeks gestation
* Less than 28 weeks gestation
* Consent for HIV testing

Exclusion Criteria:

* Less than 15 years old
B: Inclusion Criteria:

* Permanent resident in the study area
* Gestational age at the first antenatal visit ≤ 28 weeks
* HIV seropositive status
* Agreement to deliver in the study site's maternity(ies) wards

Exclusion Criteria:

* Residence outside the study area or planning to move out in the following 10 months from enrolment
* Gestational age at the first antenatal visit \> 28 weeks of pregnancy
* Known history of allergy to CTX
* Known history of allergy or contraindications to DHA-PPQ
* Participating in other intervention studies
C: Inclusion Criteria:

1. Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by ultrasound
2. Estimated gestational age between 12-20 weeks
3. Confirmed to be HIV uninfected by rapid test
4. 16 years of age or older
5. Residency within 30km of the study clinic
6. Provision of informed consent by the pregnant woman for herself and her unborn child
7. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
8. Plan to deliver in the hospital

Exclusion Criteria:

1. History of serious adverse event to SP or DP
2. Active medical problem requiring inpatient evaluation at the time of screening
3. Intention of moving more than 30km from the study clinic
4. Chronic medical condition requiring frequent medical attention
5. Prior SP preventive therapy or any other antimalarial therapy during this pregnancy
6. Early or active labor (documented by cervical change with uterine contractions)
D: Inclusion Criteria:

1. Viable pregnancy assessed by Doppler
2. Gestational age 16 to 32 weeks (inclusive) by fundal height
3. No history of IPTp use during this pregnancy
4. Willing to participate and complete the study schedule
5. Willing to sign or thumb print informed consent
6. Resident of study area and intending to stay in the area for the duration of the follow-up
7. Willing to deliver in the labor ward of the study clinic or hospital
8. HIV negative at enrolment

Exclusion Criteria:

1. HIV positive or unknown
2. Residence outside study area or planning to move out in the 12 months following enrolment
3. High risk pregnancy, including any pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease, fistula repair, leg or spine deformity)
4. Severe anemia requiring blood transfusion (Hb ≤ 7.0 g/dL) at enrolment
5. Known allergy or previous adverse reaction to any of the study drugs
6. Unable to give informed consent (for example due to mental disability)
7. Previous inclusion in the same study
8. Gestational age \>32 weeks
9. Previous IPTp during the current pregnancy
10. Participating in other malaria intervention studies
11. Known or suspected cardiac disease
12. Patients taking drugs in any of the following classes: antiarrhythmic agents, neuroleptics, macrolides, and certain antimalarial drugs such as mefloquine, chloroquine, halofantrine and lumefantrine.

Answer: A