Health Condition 1: O244- Gestational diabetes mellitus
Conditions
Interventions
Intervention1: Three arms: 3 arms namely i) diet (yogurt intervention) ii) Physical activity iii) Diet and physical activity
Control Intervention1: Controls: Standard Care
Sponsors
Department of Biotechnology Newton Fund Global Research Programme
Eligibility
Inclusion criteria
Inclusion criteria: Eligible pregnant women should be (1) aged 18 years or older (2) Gestational age 16 weeks or lesser (3) Not currently on any medications (except iron, calcium or folic acid supplements, thyroxine supplement for hypothyroidism, low dose aspirin for pre-eclampsia) AND (4) Meet at least one of the following criteria that qualifies them as “high-risk ?: for GDM • Booking BMI =25kg/m2, • Age =25 years, • First-degree relative with diabetes, • Previous pregnancy with GDM and/or pre- eclampsia/eclampsia, • Previous pregnancy with large baby (=3.5kg), • History of PCOD/impaired fasting glucose)
Exclusion criteria
Exclusion criteria: Women will be excluded if they meet one or more of the following criteria (1) GDM diagnosed prior to screening visit based on IADPSG criteria or documented raised HbA1C, i.e., either fasting glucose =5.1 mmol/L or 1h glucose =10.0 mmol/L or 2h glucose =8.5 mmol/L, or a documented HbA1c of =6.5% at first booking (2) History of pre-gestational diabetes (3) Multiple gestation in the current pregnancy (4) History of severe hyperemesis in the first trimester (5) Uncontrolled pre-gestational or gestational hypertension (BP >150/100 mmHg) or currently on treatment hypertension (6) History of recurrent (=2) first trimester spontaneous abortions or stillbirths (7) Previous child born with congenital anomalies (8) History of significant ante- or post-partum haemorrhage in the previous pregnancy. (9) Pregnancy following in-vitro fertilization or any assisted reproductive technology (10) Previous or current psychiatric illness on medication, epileptic seizures or on antiepileptic medication (11) women meeting absolute contraindications for physical activity during pregnancy as recommended by the ACOG such as heart disease, restrictive lung disease, incompetent cervix/cerclage, pregnancies at risk for premature labour, gestational hypertension (BP >150/100 mmHg), severe anemia. (12) Physical disability to PA and/or known lactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of gestational diabetes mellitus diagnosed based on IADPSG criteria at 26-28 weeks or fasting plasma glucose = 92mg/dl (=5.1 mmol/l) at week 32 Timepoint: OGTT will be performed at 26-28 weeks and/or fasting plasma glucose at week 32 of gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) fasting blood glucose at 32 weeks (2) gestational weight gain (3) Maternal BP (4) proportion of instrumental/caesarean deliveries (5) Postpartum haemorrhage (PPH) (6) pre-eclampsia and eclampsia (7) blood loss at delivery, (8) Pre-term births (less than 37 weeks of gestation) (9) Foetal macrosomia (10) birth weight, birth length and APGAR score at 1 and 5 minutes of birth. (11) Barriers to interventions in pregnancy.Timepoint: Maternal outcomes: (1) Week 32: absolute values of fasting glucose (2) Randomisation to Week 32: Gestational weight gain (3) At delivery: proportion of instrumental/caesarean deliveries, PPH, blood loss at delivery (4) Week 28: diagnosis of preeclampsia or eclampsia New born outcomes will be recorded at delivery. Barriers to interventions in pregnancy, at screening and at 32 weeks of gestation. | — |
Countries
Gambia, India
Contacts
Public ContactDrJiji Elizabeth Mathews
Christian Medical College and Hospital
Outcome results
None listed