The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract
Pregnancy Malaria, Bacterial Vaginoses, Trichomonas Vaginitis
About this trial
This is an interventional prevention trial for Pregnancy Malaria focused on measuring Pregnancy Malaria, Bacterial Vaginoses, Trichomonas Vaginitis, Zambia, Intermittent Preventive Treatment in Pregnancy (IPTp), Sulfadoxine-Pyrimethamine, Dihydroartemisinin-Piperaquine, Metronidazole, Sub-Saharan Africa
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
- HIV-negative
- Gestational age from Week 16 and 0 Days to Week 28 and 0 Days (measured by sonography)
- Carrying a single viable pregnancy
- Resident in the study area
- Express willingness to adhere to scheduled and unscheduled study visit procedures, and deliver at a trial facility
Exclusion Criteria:
- HIV-positive
- Carrying multiple pregnancies (twins, etc.),
- Known cardiac ailment
- Severe malformations or nonviable pregnancy observed by ultrasound
- History of receiving IPTp-SP during the current pregnancy
- Known allergy or contraindication to any of the study drugs
- Unable to give consent
- Concurrently participating in any other trial, including prior enrolment in this trial.
Sites / Locations
- Nchelenge District Health Facilites
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Active Comparator
IPTp-SP plus MTZ placebo (control)
IPTp-SP plus MTZ
IPTp-DP plus MTZ
3 tablets each containing 500mg sulphadoxine and 25mg pyrimethamine and metronidazole placebo administered as directly observed therapy.
3 tablets each containing 500mg sulphadoxine and 25mg pyrimethamine and 4 tablets each containing 500mg metronidazole administered as directly observed therapy .
3 tablets of 40mg of dihydroartemisinin and 320mg of piperaquine, first dose and will be administered as directly observed therapy with the remaining two doses on the next two consecutive days at home. 4 tablets each containing 500mg metronidazole administered as directly observed therapy.