Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrophysiological monitoring.
- Who it may be relevant to
- Registry conditions: Pregnancy, Monitoring. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Success rate of continuous electrophysiolgoical monitoring during maternal exercise [Time frame: 15 minutes (min) before, 30 min during and 15 min after maternal exercise]
Secondary outcome measures (12)
- Maternal heartrate [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Mean maternal heartrate [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Fetal heart rate variability [Time frame: 15 min before, 30 min during, 15 min after exercise]
- Fetal heart rate [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Contraction frequency [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Contraction duration [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Contraction intensity [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Contraction interval [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Accelerations [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Decelerations [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Signal loss [Time frame: 15 min before, 30 min during and 15 min after maternal exercise]
- Maternal satisfaction of continuous fetal monitoring and tolerability of the patch during exercise [Time frame: Directly after exercise (duration to complete: 10 min)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07077109 · NL009785