رادار التجارب السريرية

Malaria infection in pregnancy

'Malaria infection in pregnancy' is a composite outcome, defined as one or more episode of P. falciparum and/or P. vivax infection, detected by microscopy and/or qPCR in peripheral blood or placental blood, or P. falciparum and/or P. vivax infection, detected as active infection on placental histology. The surveillance period will run from two weeks after the first dose of the first monthly treatment up until and including delivery (numerator) in women who attend at least one scheduled or unscheduled visit during the surveillance period (denominator). Proportion of women with 'malaria infection in pregnancy'

Starting two weeks after initial dose until and including delivery

Adverse pregnancy outcome

Composite adverse birth outcome is defined as the occurrence of any of the following: * Spontaneous miscarriage: Fetal loss \<28 weeks of gestational age * Stillbirth: Infant born deceased at ≥28 weeks of gestational age * Low birth weight (LBW): Live birth with birth weight \<2,500 grams * Preterm birth (PTB): Live birth \<37 weeks gestational age * Small-for-gestational age (SGA): Live birth with birth weight-for-gestational-age \<10th percentile of the INTERGROWTH-21st reference * Neonatal death: Live birth with neonatal death within the first 28 days of life Prevalence of adverse pregnancy outcome

Time of delivery up to 28 days postpartum

Clinical malaria during pregnancy

Incidence of new episodes of fever or history of fever plus positive RDT confirmed by microscopy and/or qPCR during pregnancy

Starting two weeks after initial dose until and including delivery

Parasitemia during pregnancy

Proportion of samples with parasites detected in maternal peripheral blood samples by microscopy or qPCR

Starting two weeks after initial dose until and including delivery

Composite placental malaria detected by microscopy, qPCR or by histology

Prevalence of placental parasites by microscopy, qPCR, or placental histology

At time of delivery

Placental malaria detected by microscopy

Prevalence of parasites in placental blood by microscopy

At time of delivery

Placental malaria detected by qPCR

Prevalence of parasites in placental blood by qPCR

At time of delivery

Active placental malaria detected by histology

Prevalence of active infection (presence of parasites) on histology

At time of delivery

Past placental malaria detected by histology

Prevalence of past infection (pigment only) on histology

At time of delivery

Placental malaria detected by histology

Prevalence of placental infection (active or past) on histology

At time of delivery

Composite fetal loss and neonatal death

Prevalence of fetal loss (spontaneous miscarriage or stillbirth) and neonatal death

Time of delivery up to 28 days postpartum

Composite of SGA-LBW-PTB

Prevalence of small for gestational age, low birth weight, and preterm birth

At time of delivery

SGA

Prevalence of small for gestational age using the new Intergrowth-21st population reference's 10th centile

At time of delivery

LBW

Prevalence of low birth weight

At time of delivery

PTB

Prevalence of preterm birth

At time of delivery

Birth weight

Mean birthweight

At time of delivery

Neonatal length

Neonatal length

At time of delivery

Maternal nutritional status

Changes in maternal body mass index (BMI)

8 months from randomisation

Maternal nutritional status

Changes in maternal mid-upper arm circumference (MUAC)

6 months from randomisation

Maternal anemia during pregnancy and at delivery

Proportion of routine haemoglobin measurements \<100 g/L

6 months from randomisation

Maternal hemoglobin levels during pregnancy and at delivery

Mean hemoglobin (g/L) at the third trimester antenatal visit and at delivery

6 months from randomisation

Congenital anemia

Prevalence of anaemia (Hb \<130 g/L) from newborn cord blood

At delivery

Maternal gametocyte carriage during pregnancy and at delivery

Proportion of P. falciparum positive samples with gametocytes at the third trimester antenatal visit and at delivery, by light microscopy and RT-qPCR

6 months from randomisation

Molecular markers of DP resistance

Proportion of parasite positive samples with molecular markers of DP resistance

6 months from randomisation

Molecular markers of SP drug resistance

Proportion of parasite positive samples with molecular markers of SP resistance

6 months from randomisation

Maternal mortality

he death of a woman while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of the pregnancy, but not from accidental or incidental causes

8 months from randomisation

Congenital malformations

Any visible external congenital abnormality on surface examination

8 months from randomisation

Other SAEs and AEs

Incidence of AEs and SAEs

8 months from randomisation

(History) of vomiting study drug

Prevalence of vomiting investigational product (IP) twice at the same IP administration visit

6 months from randomisation

Dizziness

Prevalence of dizziness after a course of IP

6 months from randomisation

Gastrointestinal complaints

Prevalence of gastrointestinal complaints after a course of IP

6 months from randomisation