PIP (Palpitations in Pregnancy) Study Version 1
Research type
Research Study
Full title
Pilot study: performance and acceptability of a portable ECG monitor in pregnant women with palpitations
IRAS ID
326916
Contact name
Charlotte Frise
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Clinicaltrials.gov Identifier
10.17605/OSF.IO/KBPR5, DOI
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Pregnant women commonly experience palpitations. The majority are caused by extra ('ectopic') beats or a fast heart rate which is not concerning, but a minority are caused by abnormal heart rhythms, the commonest of which is supraventricular tachycardia. The diagnosis relies on capturing the abnormal rhythm at the time of symptoms, using electrocardiography (ECG). It is critical to make an accurate and timely diagnosis as prompt intervention, or more commonly reassurance, can significantly impact the wellbeing of both mother and baby.
The current standard of care is suboptimal for the identification of abnormal heart rhythms in pregnancy. The pregnant patient can wear a small monitor for 1 to 7 days, which continuously records their heart rhythm, but this is only useful when symptoms occur during the monitoring period. The unpredictable nature of palpitations means that often no issues occur during the recording period, so a normal result is of limited reassurance. The longer the recording period, the longer a woman has to wait to have the monitor attached, due to limited availability of monitoring devices. The performance of this test, as well as the time required for analysis of the results, therefore may take several weeks. This is very significant given the limited duration of pregnancy and the importance of starting treatment in a timely fashion if an abnormality is present. There is therefore a role for a simple and reliable method for anytime ECG recording.
The Kardia 6L is a simple method to obtain an ECG, using a small handheld device which communicates with an App on a compatible smartphone via Bluetooth.
We hypothesize that Kardia 6L will expedite rhythm identification whilst being user-friendly and well-received by pregnant women reporting palpitations.REC name
HSC REC B
REC reference
25/NI/0030
Date of REC Opinion
18 Apr 2025
REC opinion
Further Information Favourable Opinion