Bile Acid Effects in Fetal Arrhythmia Study

NCT03519399 | Unknown

• 1 other identifier: RJ115/N071
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Cholestasis of Pregnancy; Intrahepatic Cholestasis of Pregnancy; Obstetric Cholestasis

Keywords

Bile Acids, Fetal ECG, Stillbirth,

Outcome Measures

Primary Outcomes (1)

• Measurement of the influence of maternal bile acids levels on fetal ECG

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

  Up to 24 hours (overnight recording at home)

Secondary Outcomes (2)

• Measurement of the influence of fetal bile acids levels on fetal ECG

  Up to 24 hours (overnight recording at home)

• Measurement of the influence of maternal bile acids levels on myometrial contractility

  Up to 24 hours (overnight recording at home)

Study Arms (1)

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

Interventions

Monica AN24 DEVICE

Monica AN24 will be used to record maternal and fetal ECGs. The Zephyr will be used to determine maternal lie.

Also known as: Zephyr

Cases and Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (2)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Queen Charlotte's & Chelsea Hospital

London, W12 0NN, United Kingdom

RECRUITING

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.

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Stillbirth

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Williamson

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tharni Vavasan

CONTACT

0207 848 6202; tharni.vasavan@kcl.ac.uk

Jenny Chambers

CONTACT

07843 660349; jenny.chambers@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: February 27, 2015
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

GB (2)