DRKS00024606已完成未知
Pregnancy complications: challenge and/or chance for further cardiovascular risk in later life? - PregnancyOeNB
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- Female
入选标准
- •Group 1, uncomplicated pregnancy:
- •- uncomplicated singleton pregnancy with term delivery
- •Group 2, pregnancies complicated by gestational diabetes
- •if the woman has either:
- •- a fasting plasma glucose level of 5.6mmol/litre or above or
- •- a 2-hour plasma glucose level of 7.8mmol/litre or above. [NICE guideline, 2015]
- •Plasma glucose values exceeding the following criteria (within 24th -28th week of gestation):
- •- fasting: = 92 mg/dl (5.1 mmol/l)
- •- 1h: = 180 mg/dl (10.0 mmol/l)
- •- 2h: = 153 mg/dl (8.5 mmol/l)
- •Group 3, pregnancies complicated by preeclampsia
- •Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg, present = 20 weeks’ gestation and return to normotensive values within 12 weeks postpartum. Blood pressure measured twice, at least 4 h apart.
- •- Proteinuria (one of the following):
- •o Protein = 300 mg per 24-h urine collection
- •o Protein/creatinine ratio =0.3
- •o Protein =30 mg/dL or 1+ on urine dipstick
- •- Same as preeclampsia defined above, except one of the following must be present and proteinuria is not required (defined as subgroup severe features of preeclampsia”):
- •o Systolic blood pressure =160 mmHg, measured twice at least 15 min apart
- •o Diastolic blood pressure =110 mmHg, measured twice at least 15 min apart
- •o Thrombocytopenia: platelet count <100,000/microliter
- •o Impaired liver function: AST or ALT =70 units/L or twice the normal concentration
- •o Renal insufficiency: serum creatinine =1.1 mg/dL or doubled from baseline values
- •o Pulmonary edema
- •o Symptoms indicating possible cerebral or neurologic involvement: head-ache or visual changes (e.g. flashing, blurring, visual loss, blindness)
排除标准
- •Group 1, uncomplicated pregnancy:
- •- Elective caesarean section
- •- Medical history with pathological findings
- •Group 2, pregnancies complicated by gestational diabetes
- •Preexisting Tpye1 Diabetes mellitus
- •- Renal disease
- •- Chronic hypertension
- •- Antiphosholipid antibody syndrome
- •- Kidney transplant
- •- Hypothyroidism
- •- Pre-existing cardiovascular problems
- •- Seizures
- •Group 3, pregnancies complicated by preeclampsia
- •- Diabetes mellitus
- •- Renal disease
- •- Chronic hypertension
- •- Antiphosholipid antibody syndrome
- •- Kidney transplant
- •- Hypothyroidism
- •- Pre-existing cardiovascular problems
- •- Seizures
研究者
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