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Search / Trial NCT07077109

Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise

Launched by MAXIMA MEDICAL CENTER · Jul 11, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Electrophysiological Monitoring Pregnancy Sport Feasibility Study Maternal Exercise

ClinConnect Summary

This study is exploring whether it’s possible to continuously monitor a baby’s heart and activity signals while the mother exercises during a healthy pregnancy. The goal is to better understand how exercise affects the baby, which could help doctors give personalized advice on safe and beneficial exercise for pregnant women in the future. This could encourage more moms-to-be to stay active, supporting both their health and their baby’s wellbeing.

Women who are 18 years or older, pregnant with one baby between 30 and 40 weeks, and who regularly do aerobic exercise may be able to take part. To join, participants need to be able to understand Dutch or English and give permission to be part of the study. Some women won’t be eligible, especially if they have certain health issues like heart or lung problems, pregnancy complications, or if their baby has known health concerns. During the study, participants will wear a special monitor on their abdomen to track the baby’s signals while exercising, helping researchers see how well this monitoring works and if it’s safe. This is a first step toward making exercise during pregnancy safer and more personalized for moms and babies.

Gender

FEMALE

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)

About Maxima Medical Center

Maxima Medical Center is a leading healthcare institution dedicated to advancing medical knowledge and improving patient care through innovative clinical research. With a commitment to excellence, the center conducts a diverse range of clinical trials across various therapeutic areas, collaborating with healthcare professionals and researchers to facilitate the development of new treatments and therapies. Maxima Medical Center prioritizes patient safety and ethical standards, ensuring that all clinical studies adhere to rigorous regulatory requirements. By fostering a culture of collaboration and innovation, the center aims to contribute significantly to the medical community and enhance the quality of life for patients.

Locations

Patients applied

0 patients applied

Trial Officials

Simone Goossens, PhD

Principal Investigator

Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported