Trial · NCT04336189

Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda

NCT04336189, Phase 3, Completed, Grant Dorsey, M.D, Ph.D.; results first posted 2025-11-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda. Trials, record NCT04336189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04336189

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
NCT number: NCT04336189
Status: Completed
Phases: Phase 3
Enrollment: 2,757 participants, actual
Lead sponsor: Grant Dorsey, M.D, Ph.D.
Conditions: Malaria
Interventions: Sulfadoxine-pyrimethamine (SP), Dihydroartemisinin-piperaquine (DP)
First posted: 2020-04-07
Last updated: 2025-11-06
Results first posted: 2025-11-06

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Risk of Having a Composite Adverse Birth Outcome	Time from first dose of study drugs up to 28 days postpartum, an average of 6 months	Composite adverse birth outcome defined as the occurrence of any of the following: * Spontaneous abortion: Fetal loss at \< 28 weeks gestational age * Stillbirth: Infant born deceased at \> 28 weeks gestational age * Low Birth Weight (LBW): Live birth with birth weight \< 2500 gm * Preterm birth: Live birth at \< 37 weeks gestational age * Small-for-gestational age (SGA): Live birth with weight-for-gestational age \< 10th percentile of reference population * Neonatal death: Live birth with neonatal death within the first 28 days of life
Primary	Incidence of Serious Adverse Events (SAE) Per Time at Risk	Time from first dose of study drugs up to 28 days postpartum, an average of 6 months	SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Primary	Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk	Time from first dose of study drugs up to 28 days postpartum, an average of 6 months	Grade 3 and 4 AEs or SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Secondary	Number of Participants With Spontaneous Abortion	Time of delivery	Spontaneous abortion defined as fetal loss at \< 28 weeks gestational age
Secondary	Incidence of Anemia Adverse Event Per Time at Risk	Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months	Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Secondary	Incidence of Grade 3-4 AEs Possibly Related to Study Drugs	Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months	Grade 3-4 AEs possibly or definitely related to study drug defined by the July 2017 NIH DAIDS Toxicity Tables
Secondary	Risk of Placental Malaria	At the time of delivery	Detection of malaria parasites or pigment by histopathology
Secondary	Incidence of Malaria During Pregnancy	Day study drugs first given until delivery, an average of 6 months	Episodes of symptomatic malaria (incidence per person year at risk following initiation of study drugs)
Secondary	Microscopic Parasitemia During Pregnancy	Day study drugs first given until delivery, an average of 6 months	Proportion of routine samples with asexual parasites detected by microscopy
Secondary	Prevalence of Anemia During Pregnancy	Day study drugs are first given until delivery	Proportion of routine hemoglobin measurements \< 11 g/dL

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Risk of Having a Composite Adverse Birth Outcome	Time from first dose of study drugs up to 28 days postpartum, an average of 6 months	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence of Serious Adverse Events (SAE) Per Time at Risk	Time from first dose of study drugs up to 28 days postpartum, an average of 6 months	Events per person-years	NUMBER
PRIMARY	Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk	Time from first dose of study drugs up to 28 days postpartum, an average of 6 months	Events per person-year	NUMBER
SECONDARY	Number of Participants With Spontaneous Abortion	Time of delivery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Anemia Adverse Event Per Time at Risk	Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months	Events per person-years	NUMBER
SECONDARY	Incidence of Grade 3-4 AEs Possibly Related to Study Drugs	Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months	Events per person-years	NUMBER
SECONDARY	Risk of Placental Malaria	At the time of delivery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Malaria During Pregnancy	Day study drugs first given until delivery, an average of 6 months	Events per person-years	NUMBER
SECONDARY	Microscopic Parasitemia During Pregnancy	Day study drugs first given until delivery, an average of 6 months	Routine visits with parasitemia	NUMBER
SECONDARY	Prevalence of Anemia During Pregnancy	Day study drugs are first given until delivery	Routine visits with anemia	NUMBER

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group78

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Risk of Having a Composite Adverse Birth Outcome	SP + DP placebo every 4 weeks	222	Participants
Risk of Having a Composite Adverse Birth Outcome	DP + SP placebo every 4 weeks	261	Participants
Risk of Having a Composite Adverse Birth Outcome	SP + DP given every 4 weeks	255	Participants
Incidence of Serious Adverse Events (SAE) Per Time at Risk	SP + DP placebo every 4 weeks	0.06	Events per person-years
Incidence of Serious Adverse Events (SAE) Per Time at Risk	DP + SP placebo every 4 weeks	0.06	Events per person-years
Incidence of Serious Adverse Events (SAE) Per Time at Risk	SP + DP given every 4 weeks	0.06	Events per person-years
Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk	SP + DP placebo every 4 weeks	0.23	Events per person-year
Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk	DP + SP placebo every 4 weeks	0.19	Events per person-year
Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk	SP + DP given every 4 weeks	0.21	Events per person-year
Number of Participants With Spontaneous Abortion	SP + DP placebo every 4 weeks	12	Participants

1 to 10 of 78Source ClinicalTrials.gov

See all 78 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SP + DP placebo every 4 weeks	918
Overall Study	STARTED	DP + SP placebo every 4 weeks	920
Overall Study	STARTED	SP + DP given every 4 weeks	919
Overall Study	COMPLETED	SP + DP placebo every 4 weeks	842
Overall Study	COMPLETED	DP + SP placebo every 4 weeks	846
Overall Study	COMPLETED	SP + DP given every 4 weeks	850
Overall Study	NOT COMPLETED	SP + DP placebo every 4 weeks	76
Overall Study	NOT COMPLETED	DP + SP placebo every 4 weeks	74
Overall Study	NOT COMPLETED	SP + DP given every 4 weeks	69

Source ClinicalTrials.gov

Adverse events90

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	Gastrointestinal disorders	SP + DP placebo every 4 weeks	620	896	1,532
other	Abdominal pain	Gastrointestinal disorders	DP + SP placebo every 4 weeks	621	902	1,431
other	Abdominal pain	Gastrointestinal disorders	SP + DP given every 4 weeks	584	908	1,364
other	Cough	Respiratory, thoracic and mediastinal disorders	SP + DP placebo every 4 weeks	526	896	1,064
other	Cough	Respiratory, thoracic and mediastinal disorders	DP + SP placebo every 4 weeks	540	902	1,130
other	Cough	Respiratory, thoracic and mediastinal disorders	SP + DP given every 4 weeks	527	908	1,004
other	Headache	Nervous system disorders	SP + DP placebo every 4 weeks	510	896	947
other	Headache	Nervous system disorders	DP + SP placebo every 4 weeks	477	902	865
other	Headache	Nervous system disorders	SP + DP given every 4 weeks	436	908	769
other	Dysuria	Renal and urinary disorders	SP + DP placebo every 4 weeks	267	896	379

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SP + DP placebo every 4 weeks	1	896
Total, all-cause mortality	DP + SP placebo every 4 weeks	2	902
Total, all-cause mortality	SP + DP given every 4 weeks	0	908
Total, other adverse events	SP + DP placebo every 4 weeks	896	896
Total, other adverse events	DP + SP placebo every 4 weeks	902	902
Total, other adverse events	SP + DP given every 4 weeks	908	908
Total, serious adverse events	SP + DP placebo every 4 weeks	25	896
Total, serious adverse events	DP + SP placebo every 4 weeks	26	902
Total, serious adverse events	SP + DP given every 4 weeks	27	908

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40966190	DERIVED

Source PubMed

Grants0

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.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT04336189/registered?page=2

API reference For AI assistants