Phase 3
N=782
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT02793622 ↗Enrolled (actual)
782
Serious AEs
4.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants Who Deliver With a Composite Adverse Birth Outcome — 60; 54 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy (Drug); Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Deliver With a Composite Adverse Birth Outcome |
60; 54 | — |
| PRIMARY Incidence of Malaria in Infants |
1.98; 1.71 | — |
| PRIMARY Mean Gestational Age in Weeks at Birth |
39.4; 39.6 | — |
| SECONDARY Prevalence of Placental Malaria by Histology |
197; 94 | — |
| SECONDARY Prevalence of Placental Parasitemia |
71; 7; 29; 1 | — |
| SECONDARY Prevalence of Maternal Malaria |
28; 1 | — |
| SECONDARY Number of Participants With Adverse Events |
54; 43 | — |
| SECONDARY Prevalence of Anemia in Pregnant Women |
28; 8 | — |
| SECONDARY Prevalence of Anemia in Infants |
222; 216 | — |
| SECONDARY Prevalence of Asymptomatic Parasitemia in Pregnant Women |
519; 9 | — |
| SECONDARY Prevalence of Asymptomatic Parasitemia in Infants |
344; 357 | — |
| SECONDARY Incidence of Complicated Malaria in Infants |
44; 24 | — |
| SECONDARY Incidence of Hospital Admissions in Infants |
19; 8 | — |
| SECONDARY Infant Mortality Rate |
9; 7 | — |
Summary
This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of two intermittent preventive treatment in pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. All children born to mothers enrolled in the study will be followed from birth until they reach 12 months of age.
Eligibility Criteria
Inclusion Criteria
- Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by ultrasound
- Estimated gestational age between 12-20 weeks
- Confirmed to be HIV uninfected by rapid test
- 16 years of age or older
- Resident of Busia District, Uganda
- Provision of informed consent by the pregnant woman for herself and her unborn child
- Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
- Plan to deliver in the hospital
Exclusion Criteria
- History of serious adverse event to SP or DP
- Active medical problem requiring inpatient evaluation at the time of screening
- Intention of moving outside of Busia District, Uganda
- Chronic medical condition requiring frequent medical attention
- Prior SP preventive therapy or any other antimalarial therapy during this pregnancy
- Early or active labor (documented by cervical change with uterine contractions)
Data sourced from ClinicalTrials.gov (NCT02793622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.