CompletedNot Applicable

Day to Day Variation in Fetal Heart Rate Variability

Denmark44 participantsStarted 2018-09-01

Plain-language summary

This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy singleton pregnant women with an expected healthy fetus Exclusion Criteria: * fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Root mean square of successive inter beat interval differences (RMSSD)

Timeframe: 1/8-2020

Standard deviation of normal to normal inter beat interval (SDNN)

Timeframe: 1/8-2020

High frequency power (HF-power)

Timeframe: 1/8-2020

Low frequency power (LF-power)

Timeframe: 1/8-2020

Low frequency power/High frequency power (LF/HF)

Timeframe: 1/8-2020

Trial details

NCT IDNCT04289350

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-07-01

View on ClinicalTrials.gov More Fetal Growth Retardation trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Root mean square of successive inter beat interval differences (RMSSD)

Timeframe: 1/8-2020

Standard deviation of normal to normal inter beat interval (SDNN)

Timeframe: 1/8-2020

High frequency power (HF-power)

Timeframe: 1/8-2020

Low frequency power (LF-power)

Timeframe: 1/8-2020

Low frequency power/High frequency power (LF/HF)

Timeframe: 1/8-2020