Please select the eligibility criteria that correspond to the clinical trial below.
Title: Lungwena Antenatal Intervention Study. A Single-centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-pyrimethamine and Azithromycin
Brief Summary: The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health benefits both for the mother and the foetus/newborn.


Options:
A: Inclusion Criteria:

1. Intrauterine pregnancy confirmed by ultrasound
2. Estimated gestational age between 12-28 weeks
3. Confirmed to be HIV-infected by Uganda country standard rapid HIV test
4. 16 years of age or older
5. Residency within 30 km of the study clinic
6. Provision of informed consent
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 TS or DP
2. Refusal to take cART during pregnancy or as part of routine HIV care
3. Active medical problem requiring inpatient evaluation at the time of screening
4. Intention of moving more than 30 km from the study clinic
5. Active WHO stage 4 condition not stable under treatment
6. Signs or symptoms of early or active labor
7. Currently on ritonavir
8. Currently taking drugs associated with known risk of Torsades de pointes
9. Currently taking CYP3A inhibitor medications which potentially inhibit the metabolism of piperaquine
10. History of cardiac problems or fainting
B: Inclusion Criteria:

* Pregnant HIV positive patients
* Gestational age 16 weeks and above
* No history of use of Mefloquine or Sulphadoxine
* Pyrimethamine four weeks prior to recruitment.

Exclusion Criteria:

* Anaemia packed cell volume less than 30%
* Pre -existing medical conditions- Diabetes Mellitus, -Hypertension
* Allergy to Sulphadoxine- Pyrimethamine or Mefloquine
* Non-consenting patients
* Multiple gestation
* Known psychiatric illness
* Known seizure disorder
* History of severe renal or hepatic disease
C: Inclusion Criteria:

* Signed informed consent
* Age \>= 15 years
* Ultrasound confirmed pregnancy
* Quickening
* Foetal age 14-26 gestation weeks
* Maternal availability for follow-up during the entire study period

Exclusion Criteria:

* Known maternal tuberculosis, diabetes, kidney disease or liver disease
* Any severe acute illness warranting hospital referral at enrollment visit
* Mental disorder that may affect comprehension of the study or success of follow-up
* Twin pregnancy
* Pregnancy complications evident at enrollment visit (moderate to severe oedema, blood hemoglobin \[Hb\] concentration \< 50 g/l, systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 100 mmHg)
* Prior receipt of azithromycin during this pregnancy
* Receipt of sulfadoxine and pyrimethamine within 28 days of enrollment
* Known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
* History of anaphylaxis
* History of any serious allergic reaction to any substance, requiring emergency medical care
* Concurrent participation in any other clinical trial
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: C