ISRCTN18467720已完成未知
Pregnancy-Related Interventions in Mothers at Risk for gestational Diabetes in Asian India and Low and middle income countries (PRIMORDIAL Study)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1,870
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33597136/ protocol (added 22/02/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 07/05/2020:
- •1. Aged 18 years or older
- •2. Gestational age = 16 weeks
- •3. Meeting at least one of the following criteria for high-risk gestational diabetes mellitus (GDM):
- •3.1. Booking BMI = 25kg/m²
- •3.2. Age = 25 years
- •3.3. First-degree relative with diabetes
- •3.4. Previous pregnancy with GDM
- •3.5. Previous pregnancy with large baby (= 3.5kg)
- •3.6. Previous pregnancy with pre-eclampsia/eclampsia
- •3.7. History of PCOD/impaired fasting glucose)
- •4. Not currently on any medications (except iron, calcium or folic acid supplements, thyroxine supplement for hypothyroidism, low dose aspirin for pre-eclampsia)
- •Previous inclusion criteria:
- •1. Aged 18 years or older
- •2. Pregnant females
- •3. Gestational age >16 weeks
- •4. Meeting at least one of the following criteria for high-risk gestational diabetes mellitus (GDM):
- •4.1. BMI =25 kg/m² (for Indian women, BMI =23 kg/m²
- •4.2. First-degree relative with diabetes
- •4.3. Previous pregnancy with GDM
- •4.4. Previous pregnancy with a large baby (=3.5 kg)
- •4.5. Previous pregnancy with pre-eclampsia/eclampsia
- •4.6. History of polycystic ovary disease (PCOD) or impaired fasting glucose
- •5. Not currently on any medications (excluding iron or folic acid supplements)
排除标准
- •Current inclusion criteria as of 07/05/2020:
- •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 gestations in the current pregnancy
- •4. History of severe hyperemesis in the first trimester
- •5. Uncontrolled pre-gestational or gestational hypertension (BP > 150/100 mmHg) on treatment
- •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
- •11.1. Heart disease
- •11.2. Restrictive lung disease
- •11.3. incompetent cervix/cerclage
- •11.4. Pregnancies at risk for premature labour
- •11.5. gestational hypertension (BP > 150/100 mmHg)
- •11.6. Severe anaemia
- •Previous exclusion criteria:
- •1. Diagnosis of pre-gestational diabetes, previous GDM based on The International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria, or raised blood glucose at blooding - any of the following at first booking:
- •1.1. Fasting glucose =5.1 mmol/L
- •1.2. 1 hour glucose =10.0 mmol/L
- •1.3. 2 hour glucose =8.5 mmol/L
- •1.4. Documented HbA1c of =6.5%
- •2. Multiple gestation
- •3. History of severe hyperemesis in first trimester
- •4. History of hypertension (pre-gestational or gestational)
- •5. History or recurrent (more than two) first trimester abortions
- •6. History of ante- or post-partum haemorrhage in the previous pregnancy
- •7. Previous child born with congenital anomalies
- •8. Previous stillbirth or miscarriage
- •9. Pregnancy following in-vitro fertilisation or any assisted reproductive technology
- •10. Unwilling to adhere to the study protocol
- •11. History of or current psychiatric illness
- •12. History of or current neurological condition (i.e. epilepsy)
- •13. Meeting absolute contraindications for physical activity during preganncy as recommend by the American College of Obstetricians and Gynecologists (ACOG), including:
- •13.1. Heart disease
- •13.2. Restrictive lung disease
- •13.3. Incompetent cervix/cerclage
- •13.4. At risk for premature labour
- •13.5. Gestational hypertension
- •13.6. Severe anaemia
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