Pregnancy-Related Interventions in Mothers at Risk for gestational Diabetes in Asian India and Low and middle income countries (PRIMORDIAL Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,856
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The study is a 2x2 factorial, open-labelled, multi-centre randomized controlled trial to be conducted in Vellore, South India and The Gambia, West Africa. “High-risk†pregnant women (n=1,856) aged ≥18 years and less than 16 weeks of gestational age, with at least one risk factor for developing GDM, will be randomized to one of four arms (i) yoghurt (ii) Physical activity (PA) (iii) yoghurt + PA or (iv) standard antenatal care. Randomised women will be followed until 32 weeks of gestation with total active intervention lasting for a minimum of 14 weeks. The primary endpoint is incidence of GDM diagnosed at 26-28 weeks GA using IADPSG criteria or elevated fasting glucose at 32 weeks. A secondary endpoint is fasting plasma glucose concentration at 32 weeks gestation. Other outcomes include maternal blood pressure, gestational weight gain, intrapartum and neonatal outcomes. Analysis will be both by intention to treat and per-protocol. Continuous outcome measurements will be analysed using multiple linear regression and binary variables by logistic regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •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-riskâ€: 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).
排除标准
- •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.
结局指标
主要结局
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
时间窗: OGTT will be performed at 26-28 weeks and/or fasting plasma glucose at week 32 of gestation.
次要结局
- (1) fasting blood glucose at 32 weeks((2) gestational weight gain)