METformin in Intrahepatic Cholestasis of Pregnancy (METRIC) Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- Normalisation of maternal serum concentration of bile salts and liver enzymes
研究概览
简要总结
This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.
详细描述
Intrahepatic cholestasis is a condition that affects pregnant women. It is characterised by itching, usually in the third trimester of pregnancy and is associated with an increase in the liver enzymes and bile salts. This can be associated with maternal and neonatal morbidity, and rarely perinatal mortality.
The investigators propose to assess and compare the effect of Metformin versus Ursodeoxycholic acid on lowering liver enzymes and bile salts, improving maternal morbidity and improving neonatal outcomes.
This study is a pilot study that will be conducted at 3 NHS hospital sites where patients will randomly assigned to receive either Metformin or Ursodeoxycholic acid. There will be 20 patient in each arm. Recruitment will commence in February 2017 and will run for an 18 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20+0 to 40 weeks' gestation on day of randomisation
- •Itching with a raised serum bile acid above the upper limit of normal
- •Normal anomaly scan at 20 weeks
- •Aged 18 years or over
- •Able to give written informed consent
- •No known pre-existing liver disease
排除标准
- •Decision already made for delivery within the next 48 hours
- •Known allergy to any component of the ursodeoxycholic acid or metformin tablets
- •Patients already on metformin for other conditions
研究组 & 干预措施
Metformin arm
Metformin
干预措施: Ursodeoxycholic Acid (Drug)
Ursodeoxycholic acid
Ursodeoxycholic acid
干预措施: Metformin (Drug)
结局指标
主要结局
Normalisation of maternal serum concentration of bile salts and liver enzymes
时间窗: From date of randomisation to date of delivery assessed up to 26 weeks
Normalisation of Bile acids and liver enzymes - both parameters are the cornerstone for a diagnosis of intrahepatic cholestasis. They have been separated into two outcomes due to to the different laboratory indices of measurement. Results will be aggregated together to report number of patients with abnormal results
Normalisation of maternal serum concentration of liver enzymes
时间窗: From date of randomisation to date of delivery assessed up to 26 weeks
Normalisation of liver enzymes Alanine transaminase Aspartate transaminase Bilirubin (total) Gamma glutamyl transferase Results will be aggregated together to report the number of patients with abnormal liver enzymes
次要结局
- Fetal outcomes(Immediately upon delivery date)