Health Condition 1: O244- Gestational diabetes mellitus
Conditions
Interventions
Intervention1: Adjunct Yoga: The intervention will be delivered alongside standard antenatal care, comprising 3-5 weekly 45-minute supervised group sessions (6-10 women/cohort) plus daily 20-30 minute
Sponsors
Dr Vijaya Majumdar
Eligibility
Inclusion criteria
Inclusion criteria: Participants must meet all of the following baseline criteria and at least one GDM-risk factor adapted for Asian women per DIPSI and Indian guidelines Baseline Requirements -Gestational age less than or equal to 16 weeks -Singleton pregnancy GDM-Risk Criteria (at least one required): -Screening BMI more than or equal to 23 kg/m (Asian cutoff) -Maternal age more than or equal to 25 years -First-degree relative with diabetes -Previous pregnancy complicated by GDM -Previous delivery of large-for-gestational-age infant -Prior pregnancy with pre-eclampsia or eclampsia -History of polycystic ovarian syndrome (PCOS) or impaired fasting glucose Medication and Treatment Criteria Not currently receiving any medications, except the following permitted treatments -Iron, calcium, or folic acid supplements -Thyroxine for documented hypothyroidism For teleyoga -Stable pregnancy (no active complications: bleeding, contractions, PROM) -Pre-tele-yoga assessment: Normal BP (less than 140/90) -Family support: Adult present during first 3 sessions -Smartphone/tablet/laptop with front-facing camera
Exclusion criteria
Exclusion criteria: -GDM at screening -Pre-existing diabetes (Type 1, TYpe 2, monogenic or secondary) -Multiple pregnancy (twins, triplets, etc) -Medical contraindications to yoga or exercise -Acute shock or sepsis at recruitment -Known major fetal anomaly or estimated fetal weight less than 10th percentile -Current gestational hypertension, preeclampsia, or ruptured membranes -Substance abuse (drugs/alcohol) impairing study adherence -Severe gastrointestinal disorders Special Provision for Fertility Treatments: Women who conceived following ovulation induction with clomiphene citrate or metformin for PCOS will not be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of gestational diabetes mellitus (GDM) at 26 28 weeks of gestation, diagnosed using a 75 g oral glucose tolerance test (OGTT) and IADPSG criteria. Maternal outcomes (assessed at 26 28 weeks, 32 weeks, at delivery, and approximately. 3 months postpartum, as applicable -Fasting and 2-hour post-load plasma glucose, where feasible, HbA1c and fasting insulin -Total gestational weight gain and change in BMI -Blood pressure at each visit, and incidence of gestational hypertension and pre-eclampsia -Mode of delivery (spontaneous vaginal, assisted, caesarean), induction of labour, and intrapartum complications -Post-partum depression (3 months), maternal quality of life, and perceived stress using validated scales. Fetal outcomes -Birthweight, low birth weight, macrosomia, preterm birth, and stillbirth. -Neonatal anthropometryTimepoint: 24-26 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes (assessed at -Fasting and 2-hour post-load plasma glucose, where feasible, HbA1c and fasting insulin -Total gestational weight gain and change in BMI -Blood pressure at each visit, and incidence of gestational hypertension and pre-eclampsia -Mode of delivery (spontaneous vaginal, assisted, caesarean), induction of labour, and intrapartum complications -Post-partum depression (3 months), maternal quality of life, and perceived stress using validated scales. Timepoint: 26 28 weeks, 32 weeks, at delivery, and approximately. 3 months postpartum, as applicable;Fetal outcomes -Birthweight, low birth weight, macrosomia, preterm birth, and stillbirth. -Neonatal anthropometry -NICU stay and combined adverse neonatal events (hypoglycaemia, respiratorydistress, sepsis, or invasive ventilationTimepoint: At delivery;Mechanistic outcomes (nested sub-study) transcriptomic profiling of maternal bloodTimepoint: Baseline and 26 28 weeks | — |
Countries
India
Contacts
Public ContactDr Vijaya Majumdar
Swami Vivekananda Yoga Anusandhana S
Outcome results
None listed