ISRCTN16235884已完成未知
REduced-Carbohydrate intervention for managing Obesity and Reduction of gestational Diabetes (RECORD): a feasibility study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 51
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36581990/ (added 29/12/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38229418/ (added 22/01/2024)
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 12/10/2021:
- •1. Pregnant women at <20 weeks’ gestation
- •2. 18 years of age and above
- •3. BMI =30 kg/m² at baseline assessment
- •4. Planned antenatal care at the study setting until delivery
- •5. Women who are able to provide written informed consent
- •Previous inclusion criteria:
- •1. Pregnant women at <15 weeks’ gestation
- •2. 18 years of age and above
- •3. BMI =30 kg/m² at baseline assessment
- •4. Planned antenatal care at the study setting until delivery
- •5. Women who are able to provide written informed consent
排除标准
- •1. Severe congenital anomaly (confirmed by ultrasound)
- •2. Planned termination of pregnancy
- •3. Pre-pregnancy diagnosis of diabetes (type 1 or type 2), renal disease, severe liver disease, organ transplant, cardiac failure (Grade II New York Heart Association, and more severe), severe neurological disorder (including epilepsy), severe psychiatric disease requiring in-patient admission
- •4. A fasting plasma glucose level of 5.6 mmol/l or above or a 2-hour plasma glucose level of 7.8 mmol/l or above, at the baseline OGTT
- •5. Taking metformin, as it affects glycaemia
- •6. History or suspicion of, eating disorder
- •7. Hyperemesis gravidarum
- •8. Women unable to understand spoken and written English
- •9. Previous bariatric surgery
- •10. Women participating in other intervention research studies that may affect their weight, health behaviours or blood glucose control
- •11. Any other significant disease or disorder which, in the opinion of the Chief Investigator or clinical co-investigators, may either put the participants at risk because of participation in the trial, or may influence the result of the study, or the participant’s ability to participate in the study
研究者
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