pyrimethamine and Complications, Parasitic Pregnancy

pyrimethamine has been researched along with Complications, Parasitic Pregnancy in 348 studies

Maloprim: contains above 2 cpds

Research

Studies (348)

Authors

Clinical Trials (31)

Trial Overview

Trial Outcomes

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). (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

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. (NCT01443130)
Timeframe: 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. (NCT01443130)
Timeframe: 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. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

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. (NCT01443130)
Timeframe: 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. (NCT01443130)
Timeframe: Enrollment to delivery (approximately 12-36 weeks)

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). (NCT01443130)
Timeframe: 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. (NCT01443130)
Timeframe: From enrollment until delivery, approximately 12-36 weeks

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. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

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. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

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. (NCT01443130)
Timeframe: 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. (NCT01443130)
Timeframe: At delivery: Approximately 12-36 weeks after enrollment

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. (NCT01443130)
Timeframe: 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. (NCT01443130)
Timeframe: For 14 weeks after delivery.

Incidence of Complicated Malaria in Infants

Complicated malaria defined as an episode of malaria with danger signs (any of the following: less than 3 convulsions over 24 h, inability to sit or stand, vomiting everything, unable to breastfeed or drink) or the meeting standardized criteria for severe malaria. (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

Incidence of Hospital Admissions in Infants

Admission to the pediatric ward for any cause (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

Incidence of Malaria in Infants

episodes per person year (NCT02793622)
Timeframe: Time at risk will begin at birth and end when study participants reaches 12 months of age or early study termination

Infant Mortality Rate

Any deaths occurring after birth (NCT02793622)
Timeframe: Birth up to 12 months of age

Mean Gestational Age in Weeks at Birth

Gestational age in weeks determined by ultrasound dating (gold standard) and by the metabolic profiling outcome from biological specimens including placental tissue and placental blood. (NCT02793622)
Timeframe: At the time of delivery

Number of Participants Who Deliver With a Composite Adverse Birth Outcome

Composite adverse birth outcome defined as any one of the following: 1) Low birth weight (< 2500 gm); 2) Preterm delivery (< 37 weeks gestational age); 3) Small for gestational age (< 10th percentile relative to an external growth reference) (NCT02793622)
Timeframe: Delivery

Number of Participants With Adverse Events

All grade 3 and 4 adverse events (NCT02793622)
Timeframe: Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery

Prevalence of Anemia in Infants

"Defined as the proportion with hemoglobin < 10 g/dL measure routinely at 12, 28, and 52 weeks of age. Number of cases per person year (PPY).~This is a prevalence measure but are repeated measures during infancy. In other words we measured this outcome up to 3 times for each participant during infancy (at 12, 28 and 52 weeks of age)." (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

Prevalence of Anemia in Pregnant Women

hemoglobin < 11 g/dL (NCT02793622)
Timeframe: Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery

Prevalence of Asymptomatic Parasitemia in Infants

Proportion of routine monthly samples positive for parasites by microscopy and LAMP (NCT02793622)
Timeframe: Birth up to 12 months of age or early termination

Prevalence of Asymptomatic Parasitemia in Pregnant Women

Proportion of routine monthly samples positive for parasites by microscopy and LAMP (NCT02793622)
Timeframe: Starting at the time of their first study drug administration, approximately gestational age between 12-20 weeks, up to one month post-delivery

Prevalence of Maternal Malaria

Maternal blood positive for malaria parasites by microscopy. (NCT02793622)
Timeframe: Gestational age between 12-20 weeks (at study entry) up to delivery

Prevalence of Placental Malaria by Histology

Any evidence of placental infection (parasites or pigment). Number of participants with placental tissue positive for malaria parasites or pigment. (NCT02793622)
Timeframe: Delivery

Prevalence of Placental Parasitemia

Proportion of placental blood samples positive for parasites by Loop-mediated isothermal amplification (LAMP) or microscopy (NCT02793622)
Timeframe: Delivery

All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period

Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.

All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort

Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.

Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort

This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. (NCT00121641)
Timeframe: Baseline

Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort

This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. (NCT00121641)
Timeframe: Baseline

Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort

This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. (NCT00121641)
Timeframe: Baseline

Confirmed Hypoglycemia During ST + LT Treatment Period

'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.

Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort

'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms (NCT00121641)
Timeframe: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.

Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24

(NCT00121641)
Timeframe: Week 24

Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort

(NCT00121641)
Timeframe: Week 24

A1C Changes From Baseline at Week 24 - Open Label Cohort

To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%. (NCT00121641)
Timeframe: Baseline, Week 24

Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)

(NCT00121641)
Timeframe: Baseline, Week 24

Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort

(NCT00121641)
Timeframe: Baseline, Week 24

Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)

(NCT00121641)
Timeframe: Baseline, Week 24

Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort

(NCT00121641)
Timeframe: Baseline, Week 24

Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period

(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period

(NCT00121641)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206