Nemo Healthcare B.V. recently developed a new technique for monitoring the unborn baby. This technique is already widely used in unborn babies over 37 weeks of gestational age. The purpose of this study is to examine if that new technique is also…
ID
Source
Brief title
Condition
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of Quality judgements and Interpretability of CTG tracings for each
interval of 2 weeks from 24 to 36 weeks of gestation.
Secondary outcome
N.A.
Background summary
The condition of the unborn baby is usually assessed using cardiotocography.
The heart rate of the baby and the activity of the uterus are recorded
simultaneously. Sometimes that technique is difficult or the patients find the
tires they get to their belly annoying. By a new technique it is now possible
to do this research with a plaster on the mother's belly. This patch captures
the electrical signals from both the heart of the mother, the heart of the baby
and the uterine muscle and transmits it wirelessly through a wireless
transmitting signal. This system is called the Nemo Fetal Monitoring System
(NFMS).
We know that the NFMS works well above 37 weeks of gestational age. Now we want
to test whether this is also successful in unborn babies between 24 and 37
weeks.
Study objective
Nemo Healthcare B.V. recently developed a new technique for monitoring the
unborn baby. This technique is already widely used in unborn babies over 37
weeks of gestational age. The purpose of this study is to examine if that new
technique is also successful in unborn babies between 24 and 37 weeks
gestational age. Therefore, we will perform a 30-minute measurement at 36
pregnant volunteers who are visiting (one of) the gynecologists of the
Zuyderland Medisch Centrum. In addition, in 6 pregnant volunteers, we will
perform 6 times the same measurement during pregnancy. This serial measurements
are planned to get more information about the vernix caseosa; is this an
interference which is transiently seen in certain patient and deminishes during
progression of pregnancy or is this seen in certain patients and does not
dissapear when time is evolving.
Study design
Observational study
Study burden and risks
Participants wil have tot invest 40minutes of their time. 5 minutes for the
preparation and 30minutes registration. There are very little risks on
participation in this study, except for <5% local irritation on the abdominal
skin which will disappear within 24 hours spontaneously.
H. Dunantstraat 5
Heerlen 6419 PC
NL
H. Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
Singleton pregnancy
Gestational age between 24+0 and 35+6 weeks
Exclusion criteria
Maternal age under 18 years
Known fetal anomalies
Abdominal skin not intact or irritated
Implanted or external electrical stimulators (e.g. pacemaker)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71839.096.19 |