Bile Acid Effects in Fetal Arrhythmia Study (BEATS)
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|ClinicalTrials.gov Identifier: NCT03519399|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : August 2, 2019
Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder of pregnancy that typically presents in late pregnancy with generalised itching. 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.
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. It will also study women with uncomplicated pregnancy, in order to make comparisons.
The importance of maternal position during sleep has also more recently been established, with some studies demonstrating an association between the risk of stillbirth and the position the mother was sleeping in. Work by Stone et al published this year has shown that the maternal sleep position has a significant impact on the fetal sleep state and fetal heart rate, (in particular something called the fetal RMSSD value). The researchers therefore wish to identify any potential correlation between fetal heart arrhythmia and maternal sleep position. To do this they will use a Zephyr BioPatchTM which provides a clear indication of whether the patient was in left lateral, right lateral or supine position.
|Condition or disease||Intervention/treatment|
|Cholestasis of Pregnancy Intrahepatic Cholestasis of Pregnancy Obstetric Cholestasis||Device: Monica AN24|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official 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|
|Actual Study Start Date :||February 27, 2015|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Cases and Controls
Cases - Pregnant women with ICP defined as pruritus in pregnancy in association with raised serum bile acids (using hospital threshold for diagnosis), and in the absence of an alternative cause.
Controls - Pregnant women not affected by ICP, or other liver, cardiac or hypertensive disorders.
Device: Monica AN24
Monica AN24 will be used to record maternal and fetal ECGs. The Zephyr will be used to determine maternal lie.
Other Name: Zephyr
- Measurement of the influence of maternal bile acids levels on fetal ECG [ Time Frame: Up to 24 hours (overnight recording at home) ]To investigate the influence of maternal serum bile acid levels on the fetal ECG in women with ICP and women with uncomplicated pregnancy.
- Measurement of the influence of fetal bile acids levels on fetal ECG [ Time Frame: Up to 24 hours (overnight recording at home) ]To investigate associations between fetal bile acid levels and the fetal ECG in women with ICP and women with uncomplicated pregnancy
- Measurement of the influence of maternal bile acids levels on myometrial contractility [ Time Frame: Up to 24 hours (overnight recording at home) ]To investigate associations between maternal serum bile acid levels and myometrial contractility in women with ICP and women with uncomplicated pregnancy
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519399
|Contact: Tharni Vavasan||0207 848 firstname.lastname@example.org|
|Contact: Jenny Chambers||07843 email@example.com|
|St Thomas' Hospital||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Tharni Vavasan 02078486202 firstname.lastname@example.org|
|Principal Investigator: Catherine Williamson|
|Queen Charlotte's & Chelsea Hospital||Recruiting|
|London, United Kingdom, W12 0NN|
|Contact: Jenny Chambers 07843 660349 email@example.com|
|Principal Investigator: Muna Noori|
|Principal Investigator:||Catherine Williamson||King's College London|