CTRI/2018/07/014947招募中3 期
Pregnancy-Related Interventions in Mothers at Risk for gestational Diabetes in Asian India and Low and middle income countries (PRIMORDIAL Study)
Department of Biotechnology Newton Fund Global Research Programme0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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)
- •(4) Meet at least one of the following criteria that qualifies them as â??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
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