A total of 1900 pregnant women in the 1st trimester and their children will be enrolled and followed for two years (ORCHID study main cohort). As part of this, mother-infant pairs will be required to attend up to 10 study visits separate from routine clinic visits, these visits include 3 antenatal visits (less than or equal to 18, 24-28 and 32-36 weeks) and 16 postnatal visits (\<2 and 6 weeks, 3, 6, 12, 18, and 24 months). Participants will also be asked to engage in long-term follow-up, with visits occurring every 6 months through Month 60 (at 30, 36, 42, 48, 54, and 60 months). Measurements in mothers will include demographics and health status, HIV disease and ART use, intercurrent medical history including concomitant medication use, HIV viral load testing, ART adherence, HIV antibody testing in women without HIV; body composition, caloric intake, dysglycemia and insulin resistance (IR), lipid profiles, anthropometry, resting energy expenditure, hepatic steatosis, specimen collection (whole blood, plasma, serum, urine, placenta and breastmilk), systemic and adipose inflammation, as well as metabolites, lipid subspecies and eicosanoids. Measurements in infants will include uterine gestational age and fetal growth, as well as metabolites, lipid subspecies and eicosanoids, body composition, dysglycemia and IR, lipid profiles, anthropometry, feeding, specimen collection (cord blood, whole blood, plasma and serum) and intercurrent medical history including concomitant medication use. Additional data on maternal health in pregnancy and birth outcomes will be abstracted from medical records.
Age range
16 Years
Sex
FEMALE
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Difference in excess gestational weight gain between pregnant women living with HIV and HIV negative pregnant women
Timeframe: <18 weeks (baseline), 32-34 weeks
Difference in gestational weight gain between iDTG and cDTG pregnant women
Timeframe: <18 weeks (baseline), 32-34 weeks
Change in adipose tissue mass compared between pregnant women living with HIV and HIV negative pregnant women
Timeframe: <18 weeks (baseline), 32-34 weeks
Change in adipose tissue mass compared between iDTG and cDTG mothers
Timeframe: <18 weeks (baseline), 32-34 weeks
Differences in maternal metabolic health post-partum between mothers living with HIV and HIV negative mothers
Timeframe: <18 weeks antenatal, 24 weeks postpartum, and 24 months postpartum
Differences in maternal metabolic health post-partum between iDTG and cDTG mothers
Timeframe: <18 weeks antenatal, 24 weeks postpartum, and 24 months postpartum
Changes in adiposity in the child between HIV positive mothers and HIV negative mothers
Timeframe: <2 weeks, up to 2 years of age
Changes in adiposity in the child between iDTG and cDTG mothers
Timeframe: <2 weeks, up to 2 years of age