Pregnancy Clinical Trial
Official title:
IPTp With Dihydroartemisinin-piperaquine and Azithromycin for Malaria, Sexually Transmitted and Reproductive Tract Infections in Pregnancy in High Sulphadoxine-pyrimethamine Resistance Areas in Kenya, Malawi and Tanzania
This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.
Intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) is one of the pillars of malaria prevention in pregnancy in sub-Saharan Africa, in addition to prompt case management and use of long lasting insecticide treated bednets. However, mounting resistance to SP by Plasmodium falciparum increasing renders IPTP-SP ineffective. Two exploratory trials in Uganda and Kenya demonstrated that IPTp with DP was superior to IPTp-SP for the prevention of malaria infection in pregnancy. However, neither study was adequately powered to look at adverse birth outcomes. This study is a confirmatory efficacy trial in Malawi, Tanzania and Kenya to determine the efficacy and safety of IPTp with DP alone or in combination with AZ. This will be a 3-arm trial, superiority, partial blinded, placebo controlled, randomized trial comparing IPTp with SP, versus IPTp with DP alone, and IPTp with DP+AZ with the following hypotheses: - IPTp with DP is superior to IPTp with SP in preventing adverse pregnancy outcomes. - The combination of DP with AZ further reduces adverse pregnancy outcomes compared to IPTp with DP alone. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
| Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
| Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
| Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
| Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
| Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
| Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
| Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
| Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
| Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
| Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
| Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
| Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
| Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
| Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
| Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
| Terminated |
NCT02537145 -
PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
|