Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise

NCT ID: NCT07077109

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-03-13

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.

Detailed Description

The Nemo Fetal Monitoring Sytem (Nemo Healthcare B.V., Veldhoven, the Netherlands) will be used for electrophysiological monitoring.

Conditions

Pregnancy; Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Electrophysiological monitoring

See intervention

Group Type: EXPERIMENTAL

Electrophysiological monitoring

Intervention Type: 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.

Interventions

Electrophysiological monitoring

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• Women with absolute or relative contraindications to aerobic exercise during pregnancy at time of inclusions and during maternal exercise:

• 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
• Vasa previa
• Type 1 diabetes
• IUGR
• Severe PE
• Cervical insufficiency
• Women with relative contraindications to aerobic exercise during pregnancy:

• Mild respiratory disorders
• Mild congenital or acquired heart disease
• Well-controlled type 1 diabetes
• Pre-eclampsia
• Cervical insufficiency
• Placenta previa
• Untreated thyroid disease
• Symptomatic, severe eating disorder
• Multiple nutrient deficiencies and/or chronic undernutrition
• Moderate-heavy smoking (> 20 cigarettes per day)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maxima Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Phebe Berben

Medical doctor, PhD Candidate, Coordinating Investigator NIEM-S study

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Goossens, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Central Contacts

Phebe Berben, Medical Doctor, PhD Candidate

Role: CONTACT

phebe.berben@mmc.nl

+3140 - 888 80

Other Identifiers

NL009785

Identifier Type: -

Identifier Source: org_study_id