Trial · NCT02163447
Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants
NCT02163447, Phase 3, Completed, Grant Dorsey, M.D, Ph.D.; results first posted 2018-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants. Trials, record NCT02163447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02163447
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants
- NCT number
- NCT02163447
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Grant Dorsey, M.D, Ph.D.
- Conditions
- Malaria
- Interventions
Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy, Monthly dihydroartemisinin-piperaquine (DP) for infants, 3-monthly dihydroartemisinin-piperaquine (DP) for infants
- First posted
- 2014-06-13
- Last updated
- 2024-12-18
- Results first posted
- 2018-11-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prevalence of Placental Malaria | Delivery | Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria. |
| Primary | Incidence of Malaria in Pregnant Women | Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination | Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. |
| Primary | Incidence of Malaria in Infants | Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age) | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. |
| Primary | Incidence of Malaria in Infants | Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination | Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age. |
| Secondary | Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP | Delivery | Prevalence of placental blood samples positive for parasites by microscopy or LAMP |
| Secondary | Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery | At delivery | Prevalence of maternal parasitemia at delivery by microscopy and LAMP |
| Secondary | Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery | Delivery | Congenital malformations, spontaneous abortion, LBW (\<2500g), still birth, pre-term delivery |
| Secondary | Prevalence of Anemia in Pregnant Women | After first dose of study drugs up to delivery or early termination | Prevalence of routine hemoglobin measurements \< 11 g/dL |
| Secondary | Incidence of Complicated Malaria in Infants | Birth up to 24 months of age or early study termination | Any treatment for malaria meeting criteria for severe malaria or danger signs |
| Secondary | Incidence of Hospital Admissions in Infants | Birth up to 24 months of age or early study termination | Admission to a hospital for pediatric inpatient care for any reason |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Prevalence of Placental Malaria | Delivery | Only women who delivered and had histopathology results were analyzed. 2 women in 3 Dose SP and 1 woman in monthly DP arms completed the study but did not have histopathology results. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Malaria in Pregnant Women | Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination | events per person years | NUMBER | |
| PRIMARY | Incidence of Malaria in Infants | Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age) | All live births | Events per person years | NUMBER |
| PRIMARY | Incidence of Malaria in Infants | Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination | All live births | Events per person years | NUMBER |
| SECONDARY | Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery | At delivery | One observation in the monthly DP arm did not have results for microscopy; this outcome measure tests blood taken from the mother's arm (different from outcome measure 4 which tests blood taken from the placenta) | participants | NUMBER |
| SECONDARY | Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Prevalence of Anemia in Pregnant Women | After first dose of study drugs up to delivery or early termination | hemoglobin measurements taken every 12wk | NUMBER | |
| SECONDARY | Incidence of Complicated Malaria in Infants | Birth up to 24 months of age or early study termination | All live births | Events per person years | NUMBER |
| SECONDARY | Incidence of Hospital Admissions in Infants | Birth up to 24 months of age or early study termination | Events per person years | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Prevalence of Placental Malaria | Mothers - 3 Dose SP | 49 | Participants | ||
| Prevalence of Placental Malaria | Mothers - 3 Dose DP | 30 | Participants | ||
| Prevalence of Placental Malaria | Mothers - Monthly DP | 26 | Participants | ||
| Incidence of Malaria in Pregnant Women | Mothers - 3 Dose SP | 0.95 | events per person years | ||
| Incidence of Malaria in Pregnant Women | Mothers - 3 Dose DP | 0.31 | events per person years | ||
| Incidence of Malaria in Pregnant Women | Mothers - Monthly DP | 0 | events per person years | ||
| Incidence of Malaria in Infants | 3 Dose SP Pregnancy / 3 Monthly DP Infancy | 0.26 | Events per person years | ||
| Incidence of Malaria in Infants | 3 Dose DP Pregnancy / 3 Monthly DP Infancy | 0.30 | Events per person years | ||
| Incidence of Malaria in Infants | 3 Dose DP Pregnancy / Monthly DP Infancy | 0.00 | Events per person years | ||
| Incidence of Malaria in Infants | Monthly DP Pregnancy / 3 Monthly DP Infancy | 0.43 | Events per person years |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mothers - 3 Dose SP | 106 | |
| Overall Study | STARTED | Mothers - 3 Dose DP | 94 | |
| Overall Study | STARTED | Mothers - Monthly DP | 100 | |
| Overall Study | Infants Born | Mothers - 3 Dose SP | 101 | |
| Overall Study | Infants Born | Mothers - 3 Dose DP | 93 | |
| Overall Study | Infants Born | Mothers - Monthly DP | 100 | |
| Overall Study | COMPLETED | Mothers - 3 Dose SP | 100 | |
| Overall Study | COMPLETED | Mothers - 3 Dose DP | 88 | |
| Overall Study | COMPLETED | Mothers - Monthly DP | 97 | |
| Overall Study | NOT COMPLETED | Mothers - 3 Dose SP | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events175
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | General disorders | Mothers - 3 Dose SP | 74 | 106 | 172 |
| other | Abdominal pain | General disorders | Mothers - 3 Dose DP | 58 | 94 | 122 |
| other | Abdominal pain | General disorders | Mothers - Monthly DP | 73 | 100 | 132 |
| other | Abdominal pain | General disorders | Infants - Monthly DP | 0 | 100 | 0 |
| other | Abdominal pain | General disorders | Infants - 3 Monthly DP | 0 | 191 | 0 |
| other | Cough | General disorders | Mothers - 3 Dose SP | 55 | 106 | 94 |
| other | Cough | General disorders | Mothers - 3 Dose DP | 48 | 94 | 71 |
| other | Cough | General disorders | Mothers - Monthly DP | 57 | 100 | 77 |
| other | Cough | General disorders | Infants - Monthly DP | 94 | 100 | 1,127 |
| other | Cough | General disorders | Infants - 3 Monthly DP | 183 | 191 | 2,230 |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mothers - 3 Dose SP | 0 | 106 |
| Total, all-cause mortality | Mothers - 3 Dose DP | 0 | 94 |
| Total, all-cause mortality | Mothers - Monthly DP | 0 | 100 |
| Total, all-cause mortality | Infants - Monthly DP | 4 | 100 |
| Total, all-cause mortality | Infants - 3 Monthly DP | 3 | 191 |
| Total, other adverse events | Mothers - 3 Dose SP | 90 | 106 |
| Total, other adverse events | Mothers - 3 Dose DP | 78 | 94 |
| Total, other adverse events | Mothers - Monthly DP | 89 | 100 |
| Total, other adverse events | Infants - Monthly DP | 94 | 100 |
| Total, other adverse events | Infants - 3 Monthly DP | 183 | 191 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01HD059454 | Novel Strategies to Prevent Malaria and Improve Maternal-Child Health in Africa | HAVLIR, DIANE V | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2008 to 2017 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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