NCT04574739

Brief Summary

Fetal monitoring by transabdominal electrocardiogram recording

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 28, 2020

Last Update Submit

September 28, 2020

Conditions

To Demonstrate That a New Sensor System Can Register Fetal ECG and Distinguish it From Maternal ECG

Outcome Measures

Primary Outcomes (1)

  • The main objective of our study is to demonstrate that ELAINE sensors can register fetal ECG and distinguish it from maternal ECG, respectively to adapt them (in the CSEM laboratory) for this purpose.

    1 day

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ten singleton pregnancies with an age of gestation ≥ 37 weeks.

You may qualify if:

  • Physiological pregnancy (no diagnosed fetal malformations or other pathological conditions)
  • Physiological CTG registration
  • Physiological fetal growth
  • No diagnosed cardiac pathology of the mother
  • Written informed consent

You may not qualify if:

  • Start of labour
  • Multiple pregnancy
  • Pregnancy \< 37 weeks of gestation
  • Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
  • Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frauenklinik Inselspital

Bern, 3010, Switzerland

RECRUITING

Study Officials

  • Daniel Surbek

    Frauenklinik Inselspital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anda Radan

CONTACT

0316321010anda-petronela.radan@insel.ch

Karin Strahm

CONTACT

0316321010karin.strahm@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

July 1, 2020

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

CH(1)