Menu

Beats

Beats

Full Title: Investigation of the effect of elevated serum bile acids in intrahepatic cholestasis of pregnancy (ICP) on the fetal cardiac rhythm and on myometrial contractility: a prospective case-control pilot study

Short title: Bile acid effects in fetal arrhythmia study

Acronym: Beats

Ethics Ref: 15/WM/0017

Sponsor: King’s College London

King's College logo

Co-Sponsor: Guy’s & St Thomas’ NHS Foundation Trust

Guy's and St Thomas' logo

This study is also taking place at Queen Charlotte’s & Chelsea Hospital, London.

At the moment, no one can say for sure what causes some babies to be stillborn because of ICP. There has been some work that suggests that bile acids may have an impact on the placenta and how it functions (some of this came out of the OC Research Study) and some work to show that bile acids may cause very subtle heart arrhythmias (irregular heartbeats) in the baby that cause the heart to suddenly stop working.

At present, routine monitoring of an unborn baby’s heart rate is conducted using a machine called a cardiotocograph (CTG) machine. CTG machines measure the baby’s heart rate (as well as uterine contractions) but they cannot detect the very subtle changes in the baby’s heart that could be associated with very high bile acids, so Beats will be using a small device that measures the baby’s heart’s electrical activity and the pattern of the heart’s beats. It will also measure the mother’s heart rate.

Here are the objectives of the study, which have been taken from the protocol.

Aims

Primary objective

To investigate the influence of maternal serum bile acid levels on the fetal ECG in women with ICP and women with uncomplicated pregnancy.

Secondary objectives

To investigate:

  • associations between fetal bile acid levels and the fetal ECG in women with severe ICP and women with uncomplicated pregnancy
  • associations between maternal serum bile acid levels and myometrial contractility in women with severe ICP and women with uncomplicated pregnancy

To be able to participate in this study you need to be over 18 and live within easy travelling distance of St Thomas’ Hospital, London and Queen Charlotte’s & Chelsea Hospital, London.

Have a look at the information sheet to see what the study involves and if you are interested email Jenny Chambers: jennychambers@icpsupport.org. Contacting Jenny does not commit you to taking part; nor does it commit the hospitals to including you in the study.

Information sheet

Participant information sheet