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Bile Acid Effects in Fetal Arrhythmia Study (BEATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519399
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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
Maternal sera samples collected at recruitment. Maternal sera and umbilical cord blood sera collected following the delivery of the fetus.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Eligible women will be identified via the antenatal services at participating hospitals, and via ICP support (www.icpsupport.org).
Criteria

Inclusion Criteria:

  • 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.
  • Pregnant women who are willing and able to give consent.
  • Pregnant women ≥ 18 years of age.

Exclusion Criteria:

  • Non-pregnant women.
  • Pregnant women with medical disorders that can cause liver impairment in pregnancy e.g. pre-eclampsia, acute fatty liver of pregnancy, diabetes mellitus.
  • Pregnant women with a history of pre-existing liver or cardiac
  • Pregnant women with current hypertensive disease (this would include women taking drugs such as methyldopa, labetolol, atenolol, bisoprolol, nifedipine, amlodipine)
  • Pregnant women who are expecting more than one baby.
  • Pregnant women with blood-borne viruses e.g. HIV and hepatitis.
  • Women ≤ 18 years of age.
  • Pregnant women expecting a baby with a structural heart abnormality identified
  • Women unable or unwilling to give informed consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Tharni Vavasan 0207 848 6202 tharni.vasavan@kcl.ac.uk
Contact: Jenny Chambers 07843 660349 jenny.chambers@imperial.ac.uk

Locations
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United Kingdom
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Tharni Vavasan    02078486202    tharni.vasavan@kcl.ac.uk   
Principal Investigator: Catherine Williamson         
Queen Charlotte's & Chelsea Hospital Recruiting
London, United Kingdom, W12 0NN
Contact: Jenny Chambers    07843 660349    jenny.chambers@imperial.ac.uk   
Principal Investigator: Muna Noori         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Investigators
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Principal Investigator: Catherine Williamson King's College London

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03519399    
Other Study ID Numbers: RJ115/N071
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Bile Acids, Fetal ECG, Stillbirth,
Additional relevant MeSH terms:
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Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Bile Acids and Salts
Gastrointestinal Agents