Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise

NCT07077109 | Not Yet Recruiting DMC

• 1 other identifier: NL009785
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This feasibility study will be the first study to assess the feasibility of continuous electrophysiological monitoring during maternal exercise in women with an uncomplicated pregnancy. This may help to better understand fetal condition during exercise and offer personalised exercise recommendations in the future. In future, validating the feasibility and safety of exercise could promote greater exercise engagement among pregnant women and increase fetal wellbeiing.

Conditions

Pregnancy; Monitoring

Keywords

Electrophysiological monitoring; Pregnancy; Sport; Feasibility study; Maternal exercise

Outcome Measures

Primary Outcomes (1)

• Success rate of continuous electrophysiolgoical monitoring during maternal exercise

  Defined as the percentage of time during continuous maternal exercise with concurrent signal output of the fetal heart rate. Continous electrophysiological monitoring is feasible by a successrate of =\>80%

  15 minutes (min) before, 30 min during and 15 min after maternal exercise

Secondary Outcomes (12)

• Maternal heartrate

  15 min before, 30 min during and 15 min after maternal exercise

• Mean maternal heartrate

  15 min before, 30 min during and 15 min after maternal exercise

• Fetal heart rate variability

  15 min before, 30 min during, 15 min after exercise

• Fetal heart rate

  15 min before, 30 min during and 15 min after maternal exercise

• Contraction frequency

  15 min before, 30 min during and 15 min after maternal exercise

Study Arms (1)

Electrophysiological monitoring

EXPERIMENTAL

See intervention

Device: Electrophysiological monitoring

Interventions

Electrophysiological monitoring DEVICE

electrofysiological CTG monitoring with the Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands). The NFMS consists of a wireless and beltless electrode patch on the maternal abdomen. It monitors fetal heart rate by fetal electrocardiography, maternal heart rate by maternal electrocardiography and the electrical activity of the uterine muscle by electrohysterography.

Electrophysiological monitoring

Eligibility Criteria

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

You may qualify if:

• Minimal age of 18 years old
• Pregnant women with an uncomplicated singleton pregnancy and a gestational age between 30+0 and 40+0 weeks and days
• Oral and written informed consent is obtained
• Engage in aerobic exercise during pregnancy
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Insufficient knowledge of Dutch or English language
• Women with a multiple pregnancy
• Contra-indications for the Nemo Fetal Monitoring System (NFMS):
• Fetal and/or maternal cardiac arrhythmias
• Contraindications to abdominal placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
• Women connected to an external or implanted electrical stimulator, such as a pacemaker (because of disturbance of the electrophysiological signal)
• Fetus with known congenital or chromosomal abnormalities
• Mild or severe respiratory diseases (e.g. chronic obstructive pulmonary disease, restrictive lung disease and cystic fibrosis)
• Mild or severe acquired or congenital heart disease with exercise intolerance
• Uncontrolled or severe arrhythmia

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Officials

• Simone Goossens, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phebe Berben, Medical Doctor, PhD Candidate

CONTACT

+3140 - 888 80; phebe.berben@mmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, PhD Candidate, Coordinating Investigator NIEM-S study

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: July 22, 2025
• Study Start: October 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 13, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share