Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise (NIEM-S)

Maxima Medical Center

Status: Not yet enrolling

Conditions: Monitoring; Pregnancy

Treatments: Device: Electrophysiological monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07077109

NL009785

Details and patient eligibility

About

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.

Full description

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

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Electrophysiological monitoring

Experimental group

Description:

See intervention

Treatment:

Device: Electrophysiological monitoring