Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 4R01AI104702-04 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test prevention strategies for pregnancy-related malaria. Researchers will compare different malaria treatments and treatment schedules which include chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each time) to the standard practice of preventive treatment intervals in pregnancy (with the drug sulfadoxine-pyrimethamine given twice during pregnancy). Participants will include 900 pregnant women, who will be assigned to one of three treatment groups. Blood samples will be collected at every visit before birth and any time the participant is ill to determine if malaria is present. Pregnant women will be monitored during pregnancy and newborns will be assessed at birth and followed until about 14 weeks. Participant involvement in the study is expected to last about 12 months.
In areas of high malaria endemicity, typical of much of sub-Saharan Africa, despite having achieved semi-immunity to malaria in adulthood, women become vulnerable to malaria infection during pregnancy, especially during their first or second pregnancy. They have increased rates of infection in the peripheral blood and high concentrations of parasites can be found in the placenta. On histological examination, mature asexual parasites, forms that are not usually detected in the peripheral blood, accumulate in the placenta. Pregnancy-specific variant surface antigens are responsible for the increased vulnerability of pregnant women to malaria because they are unrecognized by the immune systems of women who encounter them for the first time in their first pregnancy. In subsequent pregnancies, women develop immunity to these parasite surface antigens and the parasites are cleared by the host response. Plasmodium (P) falciparum infection during pregnancy has important health consequences for both pregnant women and their newborns. Adverse outcomes of pregnancy-associated malaria that have been documented in Malawi include maternal anemia, low birth weight (LBW), and increased infant mortality. The primary objective of the study is to compare weekly chloroquine prophylaxis and chloroquine intermittent preventative therapy (IPT) for malaria in pregnancy (IPTp) to the standard practice [IPTp with sulfadoxine-pyrimethamine (SP)] with respect to prevention of placental malaria. The secondary objectives are: to compare weekly chloroquine prophylaxis and chloroquine IPTp to the standard practice (IPTp with SP) with respect to prevention of malaria during pregnancy; to compare weekly chloroquine prophylaxis and chloroquine IPTp to the standard practice (IPTp with SP) with respect to prevention of the adverse maternal and newborn effects of pregnancy-associated malaria. The exploratory objective identify the vulnerable periods during pregnancy when malaria infection is more likely to cause placental infection, maternal anemia, and low infant birth weight. This is a randomized controlled trial to compare chloroquine as IPT or chloroquine as chemoprophylaxis to IPTp with SP. Women will be randomized after Screening and enrollment, and they begin the assigned treatment between Week 20 and Week 28 gestation. Specimens will be collected at every prenatal visit and any time the participant is ill to determine if malaria is present. Pregnant women will be monitored during pregnancy, and newborns will be assessed at birth and followed until they are approximately 14 weeks of age. Participants will be randomized to one of the following regimens: Chloroquine approximately 1,500 mg base over 3 days, twice during pregnancy (2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2); Chloroquine base 600 mg (2 tablets) loading dose followed by 300 mg (1 tablet) orally once per week until delivery; SP 1500 mg/75 mg twice during pregnancy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloroquine IPT | Experimental | 300 subjects to receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) will be administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
|
| Chloroquine Prophylaxis | Experimental | 300 subjects to receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week. |
|
| SP IPT | Active Comparator | 300 subjects to receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroquine | Drug | Chloroquine tablets contain 300 mg chloroquine base per tablet. Dosages: Chloroquine 1,500 mg base over 3 days twice during pregnancy or Chloroquine 600 mg loading dose followed by 300 mg orally once per week. Intermittant preventative treatment in pregnancy (IPTp) doses will be administered between weeks 20-28 and weeks 28-34 gestation, 4 weeks apart. Participants randomized to IPTp with chloroquine will require their second and third doses of chloroquine after the initial dose given in the clinic and those assigned to chloroquine chemoprophylaxis will require weekly doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Placental Malaria Infection Based on Histology | The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue. | At delivery: Approximately 12-36 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Placental Malaria by Placental Impression Smear | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results. | At delivery: Approximately 12-36 weeks after enrollment |
Not provided
Inclusion Criteria:
Women who present to the Ndirande Antenatal Clinic (ANC) and meet the following inclusion criteria will be enrolled in the study: -Before the end of 27th week of gestation -First or second pregnancy -Anticipate remaining in Blantyre until 14 weeks after delivery -Agree to deliver at the Ndirande Health Centre or Queen Elizabeth Central Hospital (QECH) -Provision of informed consent
Exclusion Criteria:
-Chronic use (>14 days) of any medication with antimalarial or antifolate activity -Human immunodeficiency virus (HIV) infection -Known high-risk pregnancy requiring regular supervision of an obstetrician -Allergy to any of the study drugs
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blantyre Malaria Project - Queen Elizabeth Central Hospital | Blantryre | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36252805 | Derived | Buchwald AG, Boudova S, Peterson I, Divala T, Mungwira R, Mawindo P, Gladstone M, Cairo C, Laufer MK. The Association among Malaria in Pregnancy, Neonatal inflammation, and Neurocognitive Development in a Cohort of Malawian Infants. Am J Trop Med Hyg. 2022 Oct 17;107(5):1036-1040. doi: 10.4269/ajtmh.22-0409. Print 2022 Nov 14. | |
| 35057743 | Derived | Patson N, Mukaka M, Kazembe L, Eijkemans MJC, Mathanga D, Laufer MK, Chirwa T. Comparison of statistical methods for the analysis of recurrent adverse events in the presence of non-proportional hazards and unobserved heterogeneity: a simulation study. BMC Med Res Methodol. 2022 Jan 20;22(1):24. doi: 10.1186/s12874-021-01475-8. |
Not provided
Not provided
The infants born to these participants were also enrolled in the study to be assessed at birth and followed to 14 weeks. The infants are reported here as separate arms of the study, grouped by the study product given to the mother.
Participants were pregnant women in their first or second pregnancy recruited during presentation at the Ndirande Antenatal Clinic (ANC) at the Ndirande Health Centre, enrolled between 22 February 2012 and 16 May 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Maternal Chloroquine Prophylaxis | Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery. |
| FG001 | Maternal Chloroquine IPT | Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
| FG002 | Maternal SP IPT | Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
| FG003 | Infant Chloroquine Prophylaxis | Infants born to maternal participants who received chloroquine prophylaxis. |
| FG004 | Infant Chloroquine IPT | Infants born to maternal participants who received chloroquine IPT. |
| FG005 | Infant SP IPT | Infants born to maternal participants who received SP IPT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants enrolled in the study are included in the baseline analysis population, with the exception of the age continuous for all groups, which is limited to the maternal participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Maternal Chloroquine Prophylaxis | Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery. |
| BG001 | Maternal Chloroquine IPT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Placental Malaria Infection Based on Histology | The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue. | All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis. | Posted | Number | 97.5% Confidence Interval | percentage of pregnancies | At delivery: Approximately 12-36 weeks after enrollment |
|
Adverse events and serious adverse events were collected after the administration of the first dose of study drug throughout the duration of the follow-up period (approximately 14 weeks following delivery).
Not provided
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 | Maternal Chloroquine Prophylaxis | Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
The observed placental malaria rate was lower than expected causing the study to be under powered. After review of a futility analysis, the Sponsor and DSMB recommended allowing the study to conclude as planned and not to increase the sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miriam K. Laufer, MD, MPH | University of Maryland School of Medicine | 410-706-5333 | mlaufer@medicine.umaryland.edu |
Not provided
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| C001205 | fanasil, pyrimethamine drug combination |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sulfadoxine-pyrimethamine | Drug | Sulfadoxine-pyrimethamine 3 tablets (1,500 mg sulfadoxine and 75 mg pyrimethamine) twice during pregnancy. Intermittant preventive treatment in pregnancy (IPTp) doses will be administered between weeks 20-28 and weeks 28-34, 4 weeks apart. |
|
| Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter) |
Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL). |
| From enrollment until delivery, approximately 12-36 weeks |
| Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl) | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl. | From enrollment until delivery, approximately 12-36 weeks |
| Incidence of Stillbirth | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation. | At delivery: Approximately 12-36 weeks after enrollment |
| Incidence of Miscarriage | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation. | At delivery: Approximately 12-36 weeks after enrollment |
| Incidence of Preterm Delivery | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage. | At delivery: Approximately 12-36 weeks after enrollment |
| Infant Mortality Rate to 14 Weeks of Age | Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery. | For 14 weeks after delivery. |
| Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams) | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams. | At delivery: Approximately 12-36 weeks after enrollment |
| Incidence of Intrauterine Growth Restriction (IUGR) | Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar. | At delivery: Approximately 12-36 weeks after enrollment |
| Incidence of Active Placental Malaria Infection | Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR). | At delivery: Approximately 12-36 weeks after enrollment |
| Incidence of Malaria Infection, All Species. | Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects. | Enrollment to delivery (approximately 12-36 weeks) |
| Incidence of Clinical Malaria, All Species | Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness. | Enrollment to delivery (approximately 12-36 weeks) |
| Incidence of Infection in the Fetal Circulation | Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample. | At delivery: Approximately 12-36 weeks after enrollment |
| 35045119 | Derived | Patson N, Mukaka M, Peterson I, Divala T, Kazembe L, Mathanga D, Laufer MK, Chirwa T. Effect of adverse events on non-adherence and study non-completion in malaria chemoprevention during pregnancy trial: A nested case control study. PLoS One. 2022 Jan 19;17(1):e0262797. doi: 10.1371/journal.pone.0262797. eCollection 2022. |
| 30195996 | Derived | Divala TH, Mungwira RG, Mawindo PM, Nyirenda OM, Kanjala M, Ndaferankhande M, Tsirizani LE, Masonga R, Muwalo F, Boudova S, Potter GE, Kennedy J, Goswami J, Wylie BJ, Muehlenbachs A, Ndovie L, Mvula P, Mbilizi Y, Tomoka T, Laufer MK. Chloroquine as weekly chemoprophylaxis or intermittent treatment to prevent malaria in pregnancy in Malawi: a randomised controlled trial. Lancet Infect Dis. 2018 Oct;18(10):1097-1107. doi: 10.1016/S1473-3099(18)30415-8. Epub 2018 Sep 5. |
| Death |
|
| Adverse Event |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Death of Subject's Infant |
|
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
| BG002 | Maternal SP IPT | Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
| BG003 | Infant Chloroquine Prophylaxis | Infants born to maternal participants who received chloroquine prophylaxis. |
| BG004 | Infant Chloroquine IPT | Infants born to maternal participants who received chloroquine IPT. |
| BG005 | Infant SP IPT | Infants born to maternal participants who received SP IPT. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Maternal Chloroquine IPT |
Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
| OG002 | Maternal SP IPT | Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. |
|
|
|
| Secondary | Incidence of Placental Malaria by Placental Impression Smear | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results. | The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed. | Posted | Number | 97.5% Confidence Interval | percentage of placentas | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| Secondary | Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter) | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL). | The analysis population includes all maternal participants. | Posted | Number | 97.5% Confidence Interval | percentage of maternal participants | From enrollment until delivery, approximately 12-36 weeks |
|
|
|
|
| Secondary | Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl) | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl. | The analysis population includes all maternal participants. | Posted | Number | 97.5% Confidence Interval | percentage of maternal participants | From enrollment until delivery, approximately 12-36 weeks |
|
|
|
|
| Secondary | Incidence of Stillbirth | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation. | The analysis population includes all participants whose pregnancies were followed to delivery. | Posted | Number | 97.5% Confidence Interval | percentage of deliveries | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| Secondary | Incidence of Miscarriage | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation. | The analysis population includes all maternal participants. | Posted | Number | 97.5% Confidence Interval | percentage of pregnancies | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| Secondary | Incidence of Preterm Delivery | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage. | The analysis population includes all participants whose pregnancies were followed to delivery. | Posted | Number | 97.5% Confidence Interval | percentage of deliveries | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| Secondary | Infant Mortality Rate to 14 Weeks of Age | Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery. | The analysis population includes all enrolled infants. | Posted | Number | 97.5% Confidence Interval | percentage of infants | For 14 weeks after delivery. |
|
|
|
|
| Secondary | Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams) | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams. | The analysis population includes all infants born alive with weight data collected at birth. | Posted | Number | 97.5% Confidence Interval | percentage of infants | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| Secondary | Incidence of Intrauterine Growth Restriction (IUGR) | Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar. | This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery. | Posted | Number | 97.5% Confidence Interval | percentage of participants | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| Secondary | Incidence of Active Placental Malaria Infection | Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR). | This analysis population includes all maternal subjects with placental slides reviewed and PCR results obtained. | Posted | Number | 97.5% Confidence Interval | percentage of participants | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| Secondary | Incidence of Malaria Infection, All Species. | Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects. | The analysis population includes all maternal participants. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Enrollment to delivery (approximately 12-36 weeks) |
|
|
|
|
| Secondary | Incidence of Clinical Malaria, All Species | Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness. | The analysis population includes all maternal participants. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Enrollment to delivery (approximately 12-36 weeks) |
|
|
|
|
| Secondary | Incidence of Infection in the Fetal Circulation | Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample. | The analysis population includes all maternal participants with cord blood smears and cord PCR results obtained. | Posted | Number | 97.5% Confidence Interval | percentage of participants | At delivery: Approximately 12-36 weeks after enrollment |
|
|
|
|
| 23 |
| 300 |
| 255 |
| 300 |
| EG001 | Maternal Chloroquine IPT | Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. | 29 | 300 | 251 | 300 |
| EG002 | Maternal SP IPT | Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks. | 26 | 300 | 234 | 300 |
| EG003 | Infant Chloroquine Prophylaxis | Infants born to maternal participants who received chloroquine prophylaxis. | 46 | 270 | 195 | 270 |
| EG004 | Infant Chloroquine IPT | Infants born to maternal participants who received chloroquine IPT. | 65 | 274 | 186 | 274 |
| EG005 | Infant SP IPT | Infants born to maternal participants who received SP IPT. | 43 | 259 | 171 | 259 |
| Anaemia of pregnancy | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Bartholin's abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Postpartum sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Prolonged rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Brief psychotic disorder, with postpartum onset | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Accessory auricle | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Polydactyly | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Talipes | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Umbilical cord haemorrhage | Congenital, familial and genetic disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Death neonatal | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Sudden infant death syndrome | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Group B streptococcus neonatal sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Feeding disorder neonatal | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Neonatal aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Melanosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vacuum extractor delivery | Surgical and medical procedures | MedDRA (18.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Skin bacterial infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
Not provided
| D000079426 |
| Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |
The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.4990 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.6973 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 1.00 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.1166 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 1.000 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.2163 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.8127 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.7839 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.4354 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.4947 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.4184 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Cox proportional hazards |
| 0.1646 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |
The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT. |
| Fisher Exact |
| 0.1758 |
A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025. |
| No |
| Superiority or Other |