Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Infectious Diseases Research Collaboration, Uganda | OTHER |
Not provided
Not provided
Not provided
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. This double-blinded randomized controlled phase III trial of 2757 HIV uninfected pregnant women enrolled at 12-20 weeks gestation will be randomized in equal proportions to one of three IPTp treatment arms: 1) SP given every 4 weeks, or 2) DP given every 4 weeks, or 3) SP+DP given every 4 weeks. SP or DP placebos will be used to ensure adequate blinding is achieved in the study and follow-up will end 28 days after giving birth.
Malaria in pregnancy remains a major challenge in Africa, where approximately 50 million women are at risk for P. falciparum infection during pregnancy each year. Among pregnant women living in malaria endemic areas symptomatic disease is uncommon, but infection with malaria parasites is associated with maternal anemia and adverse birth outcomes including abortions, stillbirth, preterm birth, low birth weight (LBW), and infant mortality. The World Health Organization (WHO) recommends the use of long-lasting insecticidal nets (LLINs) and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) for the prevention of malaria in pregnancy in endemic areas of Africa. However, there is concern for diminishing efficacy of these interventions due to the spread of vector resistance to the pyrethroid insecticides used in LLINs and parasite resistance to SP. Thus, there is an urgent need for new strategies for the prevention of malaria in pregnancy and improving birth outcomes. Artemisinin-based combination therapies (ACTs) are now the standard treatment for malaria in Africa. Dihydroartemisin-piperaquine (DP) is a fixed-dose ACT and an attractive alternative to SP for IPTp. DP is highly efficacious, and the long half-life of piperaquine provides at least 4 weeks of post-treatment prophylaxis. Recent randomized controlled trials showed that, compared to IPTp with SP, IPTp with DP dramatically reduced risks of malaria-specific outcomes but there were minimal differences between the SP and DP groups in risks of adverse birth outcomes. The key question for this study is why IPTp with either SP or DP is associated with similar risks of adverse birth outcomes despite the far superior antimalarial activity of DP. The likely explanation is that SP, a broad-spectrum antibiotic, protects against non-malarial causes of LBW and preterm birth. The central hypothesis is that SP improves birth outcomes independent of its antimalarial activity and that IPTp with a combination of SP+DP will offer antimalarial and non-antimalarial benefits, thus providing superior prevention of adverse birth outcomes compared to either drug used alone. To test this hypothesis, a double-blinded randomized clinical trial will conducted in a rural area of Uganda with very high malaria transmission intensity, where there is already an established infrastructure for clinical research. Specific aims will be (1) to compare the risk of adverse birth outcomes among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP, (2) To compare safety and tolerability of IPTp regimens among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP, and (3) to compare risks of malaria-specific and non-malarial outcomes among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP. This study will be the first to evaluate the efficacy and safety of a novel combination of well-studied drugs for improving birth outcomes and findings may well have important policy implications, with a change in standard practice for millions of pregnant women in Africa.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP + DP placebo every 4 weeks | Active Comparator |
| |
| DP + SP placebo every 4 weeks | Active Comparator |
| |
| SP + DP given every 4 weeks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfadoxine-pyrimethamine (SP) | Drug | SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Having a Composite Adverse Birth Outcome | Composite adverse birth outcome defined as the occurrence of any of the following:
| Time from first dose of study drugs up to 28 days postpartum, an average of 6 months |
| Incidence of Serious Adverse Events (SAE) Per Time at Risk | SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months |
| Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk | Grade 3 and 4 AEs or SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Spontaneous Abortion | Spontaneous abortion defined as fetal loss at < 28 weeks gestational age | Time of delivery |
| Incidence of Anemia Adverse Event Per Time at Risk |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant women
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Grant Dorsey, MD, PhD | University of California, San Francisco | Principal Investigator |
| Phil Rosenthal, MD | University of California, San Francisco | Principal Investigator |
| Moses Kamya, MBChB, MMed, PhD | Makerere University; Infectious Diseases Research Collaboration | Principal Investigator |
| Abel Kakuru, MBChB, PhD | Infectious Diseases Research Collaboration | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Research Collaboration Clinic - Masafu Hospital | Masafu | Busia | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40966190 | Derived | Kakuru A, Kizza J, Aguti M, Adrama H, Ategeka J, Olwoch P, Nakalembe M, Nankabirwa JI, Opira B, Ozarslan N, Ranjit A, Dela Cruz E, Clark TD, Roh ME, Gaw SL, Jagannathan P, Rosenthal PJ, Kamya MR, Dorsey G. Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus either drug alone for intermittent preventive treatment of malaria in pregnancy: A double-blind, randomized, controlled phase 3 trial from Uganda. PLoS Med. 2025 Sep 18;22(9):e1004582. doi: 10.1371/journal.pmed.1004582. eCollection 2025 Sep. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SP + DP placebo every 4 weeks | Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. |
| FG001 | DP + SP placebo every 4 weeks | Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. |
| FG002 | SP + DP given every 4 weeks | Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SP + DP placebo every 4 weeks | Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. |
| BG001 | DP + SP placebo every 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Risk of Having a Composite Adverse Birth Outcome | Composite adverse birth outcome defined as the occurrence of any of the following:
| Posted | Count of Participants | Participants | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months |
|
Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events, version 2017
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SP + DP placebo every 4 weeks | Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Dorsey | UCSF | 415-310-0525 | grant.dorsey@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 11, 2023 | Jun 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2023 | Jun 23, 2025 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008288 | Malaria |
| D060737 | Reproductive Tract Infections |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
Not provided
Not provided
Not provided
Double blinded randomized controlled trial
Not provided
Not provided
Placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo or DP and placebo or SP and DP) followed by one drug on days 2 and 3 (DP or placebo). Two placebos will be used, one that mimics the appearance of SP and one that mimics the appearance of DP. A randomization list will be computer generated by a member of the project who will not be directly involved in the conduct of the study. The randomization list will include consecutive treatment numbers with corresponding random treatment assignments. Randomized codes will correspond to the 3 treatment arms using permuted variable sized blocks of 6 and 9.
|
| Dihydroartemisinin-piperaquine (DP) | Drug | DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. |
|
|
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
| Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Grade 3-4 AEs Possibly Related to Study Drugs | Grade 3-4 AEs possibly or definitely related to study drug defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Risk of Placental Malaria | Detection of malaria parasites or pigment by histopathology | At the time of delivery |
| Incidence of Malaria During Pregnancy | Episodes of symptomatic malaria (incidence per person year at risk following initiation of study drugs) | Day study drugs first given until delivery, an average of 6 months |
| Microscopic Parasitemia During Pregnancy | Proportion of routine samples with asexual parasites detected by microscopy | Day study drugs first given until delivery, an average of 6 months |
| Prevalence of Anemia During Pregnancy | Proportion of routine hemoglobin measurements < 11 g/dL | Day study drugs are first given until delivery |
| Stillbirth | Stillbirth defined as infant born deceased at > 28 weeks gestational age | Time of delivery |
| Low Birth Rate | Low birth weight defined as live birth with birth weight < 2500 gm | Time of delivery |
| Preterm Delivery | Preterm delivery defined as live birth at < 37 weeks gestational age | Time of delivery |
| Small-for-gestational Age | Small-for-gestational age defined as live birth with weight-for-gestational age < 10th percentile of reference population | Time of delivery |
| Neonatal Death | Neonatal death defined as live birth with neonatal death within the first 28 days of life | Time of delivery |
| Microscopic or Sub-microscopic Parasitemia During Pregnancy | Proportion of routine samples with asexual parasites detected by microscopy or qPCR | Day study drugs first given until delivery, an average of 6 months |
| Prevalence of Severe Anemia During Pregnancy | Proportion of routine hemoglobin measurements < 8 g/dL | Day study drugs are first given until delivery, an average of 6 months |
| Incidence of Stillbirth Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Congenital Anomaly Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Neutropenia Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Proteinuria Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Thrombocytopenia Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Postpartum Hemorrhage Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Pre-eclampsia Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Preterm Birth <28 Gestational Age Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
| Incidence of Elevated Temperature Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months |
Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. |
| BG002 | SP + DP given every 4 weeks | Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Mean | Standard Deviation | weeks |
|
| Gestational age categories | Count of Participants | Participants |
|
| Gravidity | Count of Participants | Participants |
|
| Bednet ownership | Count of Participants | Participants |
|
| Household wealth index | Data not collected from 29 participants | Count of Participants | Participants |
|
| Highest level of education | Count of Participants | Participants |
|
| Weight in kg | Mean | Standard Deviation | kg |
|
| Height in cm | Mean | Standard Deviation | cm |
|
| Maternal MUAC | Mean | Standard Deviation | cm |
|
| Mean hemoglobin | Mean | Standard Deviation | g/dL |
|
| Prevalence of dhfr/dhps quintuple mutant markers of antifolate resistance | Randomly subset of 200 participant samples with parasite density >100/microliter | Number | participants |
|
| Detection of malaria parasites by microscopy or qPCR | Count of Participants | Participants |
|
| OG001 | DP + SP placebo every 4 weeks | Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. |
| OG002 | SP + DP given every 4 weeks | Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. |
|
|
| Primary | Incidence of Serious Adverse Events (SAE) Per Time at Risk | SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months | person years | person years |
|
|
|
| Primary | Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk | Grade 3 and 4 AEs or SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-year | Time from first dose of study drugs up to 28 days postpartum, an average of 6 months | Person years | Person years |
|
|
|
| Secondary | Number of Participants With Spontaneous Abortion | Spontaneous abortion defined as fetal loss at < 28 weeks gestational age | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Incidence of Anemia Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | Person years | Person years |
|
|
|
| Secondary | Incidence of Grade 3-4 AEs Possibly Related to Study Drugs | Grade 3-4 AEs possibly or definitely related to study drug defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | Person years | Person years |
|
|
|
| Secondary | Risk of Placental Malaria | Detection of malaria parasites or pigment by histopathology | Posted | Count of Participants | Participants | At the time of delivery |
|
|
|
| Secondary | Incidence of Malaria During Pregnancy | Episodes of symptomatic malaria (incidence per person year at risk following initiation of study drugs) | Posted | Number | Events per person-years | Day study drugs first given until delivery, an average of 6 months | Person years | Person years |
|
|
|
| Secondary | Microscopic Parasitemia During Pregnancy | Proportion of routine samples with asexual parasites detected by microscopy | Posted | Number | Routine visits with parasitemia | Day study drugs first given until delivery, an average of 6 months | Routine visits | Routine visits |
|
|
|
| Secondary | Prevalence of Anemia During Pregnancy | Proportion of routine hemoglobin measurements < 11 g/dL | Posted | Number | Routine visits with anemia | Day study drugs are first given until delivery | Routine visits | Routine visits |
|
|
|
| Secondary | Stillbirth | Stillbirth defined as infant born deceased at > 28 weeks gestational age | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Low Birth Rate | Low birth weight defined as live birth with birth weight < 2500 gm | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Preterm Delivery | Preterm delivery defined as live birth at < 37 weeks gestational age | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Small-for-gestational Age | Small-for-gestational age defined as live birth with weight-for-gestational age < 10th percentile of reference population | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Neonatal Death | Neonatal death defined as live birth with neonatal death within the first 28 days of life | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Microscopic or Sub-microscopic Parasitemia During Pregnancy | Proportion of routine samples with asexual parasites detected by microscopy or qPCR | Posted | Number | routine visits with parasitemia | Day study drugs first given until delivery, an average of 6 months | routine visits | routine visits |
|
|
|
| Secondary | Prevalence of Severe Anemia During Pregnancy | Proportion of routine hemoglobin measurements < 8 g/dL | Posted | Number | Routine visits with severe anemia | Day study drugs are first given until delivery, an average of 6 months | Routine visits | Routine visits |
|
|
|
| Secondary | Incidence of Stillbirth Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-year | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Congenital Anomaly Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-year | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Neutropenia Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-year | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Proteinuria Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Thrombocytopenia Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Postpartum Hemorrhage Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Pre-eclampsia Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Preterm Birth <28 Gestational Age Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-years | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| Secondary | Incidence of Elevated Temperature Adverse Event Per Time at Risk | Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables | Posted | Number | Events per person-year | Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months | person years | person years |
|
|
|
| 1 |
| 896 |
| 25 |
| 896 |
| 896 |
| 896 |
| EG001 | DP + SP placebo every 4 weeks | Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. | 2 | 902 | 26 | 902 | 902 | 902 |
| EG002 | SP + DP given every 4 weeks | Sulfadoxine-pyrimethamine (SP): SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. Dihydroartemisinin-piperaquine (DP): DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. | 0 | 908 | 27 | 908 | 908 | 908 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Post-partum hemmorrha | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Septicemia | Infections and infestations | Systematic Assessment |
|
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Abruptio placenta | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Congenital anomoly | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Transverse myelitis | Nervous system disorders | Systematic Assessment |
|
| Puerperal sepsis | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Deep laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Thrombocytopenia | Renal and urinary disorders | Systematic Assessment |
|
| Preterm birth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Elevated temperature | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D000079426 |
| Vector Borne Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| >16 weeks |
|
| Multigravidae |
|
| Untreated net |
|
| Long-lasting insecticide-treated net |
|
| Middle tertile |
|
| Highest tertile |
|
| Primary school |
|
| Secondary school |
|
| Higher |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|