Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Singleton pregnancies 2. 11-14 weeks’ gestation (as confirmed by ultrasound scan) during the recruitment windows: a. For the GCH site: Warmest months- (April-July) and coolest months (November- February); b.For Pondicherry- warmest month- March-June and coolest- November-February) c.For Chhattisgarh Site: March-June warmest months; November- February coolest months; Risk of high heat exposure based on their occupation and household exposure. 3.Provides consent to all the home/work-based assessments and study assessments throughout pregnancy
Exclusion criteria
Exclusion criteria: 1.Regular access to fixed air conditioning in their home or regular place of work (excluding fans and coolers) 2.An underlying severe medical condition (e.g. end-stage renal failure, cardiac disease, cancer, severe mental health problems, severe anaemia, severe endocrine and metabolic disorders) 3.Plan to move away from the study location before the end of their pregnancy 4.Active vaginal bleeding at the time of recruitment 5.Suspicion of chromosomal abnormalities at first trimester scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physiological outcomes: 1. Maternal Haemodynamics 2. Foetal and placental assessments via ultrasound and cardiotocography 3. Placental circulating biomarkers 4. Lactational assessment- composition, maturation, serum lactation hormones Timepoint: Continuous measurements across pregnancy and early lactation period | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Pregnancy outcomes: 1. Pre-term birth 2. Stillbirth 3. Small for Gestational Age 4. Pre-eclampsia 5. Gestational DiabetesTimepoint: End of Pregnancy | — |
Countries
India
Contacts
Translational Health Science and Technology Institute, Faridabad