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Feasibility study: continuous fetal monitoring during maternal exercise

Continuous non-invasive electrophysiological monitoring during maternal exercise: a feasibility study - Feasibility study: continuous fetal monitoring during maternal exercise

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57885
Enrollment
15
Registered
2025-04-01
Start date
2025-10-28
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Pregnancy Pregnancy

Interventions

NFMS

Sponsors

Máxima MC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Minimal age of 18 years oldPregnant women with an uncomplicated singleton pregnancy and a gestational age between 30+0 and 40+0 weeks and daysOral and written informed consent is obtained 

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Insufficient knowledge of Dutch or English languageWomen with a multiple pregnancyContra-indications for the Nemo Fetal Monitoring System (NFMS):Fetal and/or maternal cardiac arrhythmiasContraindications 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 abnormalitiesWomen 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 intoleranceUncontrolled or severe arrhythmia Vasa previa Type 1 diabetesIUGRPre-eclampsiaCervical insufficiency Placenta previaUntreated thyroid diseaseSymptomatic, severe eating disorderMultiple nutrient deficiencies and/or chronic undernutritionModerate-heavy smoking (> 20 cigarettes per day) 

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is success rate, defined as percentage of time with good signal quality of fetal heart rate

Secondary

MeasureTime frame
Secondary outcome measures are CTG characteristics and maternal satisfaction with continuous monitoring during exercise. 

Countries

Netherlands

Contacts

Public ContactP.B.Q. Berben

Máxima MC

phebe.berben@mmc.nl040 – 888 80 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026