Monitoring fetal movements utilising fetal movement monitoring device named as Fetal Kicks

Investigating the utility of Fetal Kicks to monitor fetal movements in pregnant women who have experienced a reduction in the perception of fetal movements

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000410358

Enrollment

Registered

2017-03-21

Start date

2017-04-03

Completion date

2018-04-02

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Fetal Kicks is a novel device developed by Monash MIME to monitor fetal movement. For the following study, the current phase entails a proof of concept in women antenatally to assess the quality of signals obtained on Fetal Kicks. For this, Fetal Kicks will be utilised together with the conventional cardiotocography (CTG) to ascertain the equivalence of Fetal Kicks with conventional fetal movement counting Aims 1. Accurately corroborating maternal perceptions of movements on the CTG (via sensor imprints) to device captures of fetal movements 2. Accurately corroborating maternal perceptions of movements on the ultrasound (via sensor imprints) to device captures of fetal movements Research design The following study is a cross sectional survey with a cohort design. The following design has been chosen as it is considered to be the design of choice in evaluating a diagnostic test- in this case, Fetal Kicks. Utilising the following design, measurements of test accuracy and precision will be carried out on Fetal Kicks in comparison to CTG and conventional fetal movement countings. Primary Outcomes 1. Correlation between the signals obtained from Fetal Kicks and routine cardiotocography over a similar time period. This will be done electronically utilising cross correlation. 2. Correlation between the information obtained from Fetal Kicks and CTG as interpreted by clinicians. This will be measured on a CTG reporting tool designed specifically for the study. Secondary Outcomes: 1. Patient view on Fetal Kicks (i.e pros, cons, will they recommend it, areas for improvement etc.). This will be measured through a questionnaire designed specifically for the study

Interventions

Participants will utilise routine cardiotocography (CTG) by obstetrician to monitor the fetal movements of the fetus antenatally. At the same time, a novel device , the Fetal Kicks will be attached to their abdomen to monitor the fetal movement as well. Fetal Kicks utilises a strain gauge sensor to monitor the fetal movements. For this study, Fetal Kicks will not be utilised to guide care and only for passive monitoring. This process will take place for a duration of 30 minutes. Fetal Kicks moni

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Have a singleton pregnancy Should be pregnant and above 28 weeks of pregnancy Should be aware of what normal fetal movements are Have experienced a reduction in the perception of fetal movements from what they are usually used to

Exclusion criteria

Women below 18 years of age Patients with an intellectual or mental impairment People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process People highly dependent on medical care

Outcome results