Bile Acid Effects on Fetal Arrhythmia after UDCA Therapy Study (BEATS)
Research type
Research Study
Full title
Investigation into the effect of elevated serum bile acids in obstetric cholestasis on the fetal cardiac rhythm and on myometrial contractility, and assessment of the impact of UDCA on these.
IRAS ID
105123
Contact name
Bashir Al-Hashimi
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
9 years, 3 months, 31 days
Research summary
Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder of pregnancy that typically presents in late pregnancy with generalised itching. Blood tests in the mother show elevated levels of bile acids and abnormal liver function. ICP is associated with an increased risk of pregnancy complications, including premature labour, fetal distress, and stillbirth. Models of the fetal heart (using cells from rodents) have shown that high bile acids levels cause an abnormal heart rhythm (arrhythmia), which may be the cause of stillbirth. High levels of bile acids also cause preterm labour in animal models. Ursodeoxycholic acid (UDCA) is the conventional treatment for ICP, and seems to reduce the risk of complications by lowering the levels of bile acids in the mother’s blood. Furthermore, in the models of the fetal heart, it also protects against the bile acid-induced arrhythmias.
This pilot study aims to assess whether severe ICP, defined as maternal serum bile acid levels ≥40μmol/L, is associated with abnormal fetal heart rhythms and abnormal myometrial contractility, which may lead to preterm birth. Fetal heart rhythms and myometrial contractility will be recorded using a portable electrocardiogram (ECG) device, the Monica AN24. This monitors the fetal heart and myometrial activity via stickers applied to the mother’s abdomen. It also records the maternal ECG. Women will be asked to wear the device for up to 24-hours at recruitment and for up to 24-hours weekly thereafter until delivery. They will also be asked to wear the device on the day that UDCA treatment is commenced, and on days when the dose of UDCA is changed. At each visit we will take a maternal blood sample to measure bile acids and liver function. We will also study women with uncomplicated pregnancy, in order to make comparisons.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0017
Date of REC Opinion
10 Feb 2015
REC opinion
Further Information Favourable Opinion