To study whether an existing sensor device containing motion/orientation sensors (SMM; Senior Mobility Monitor) can be used to observe progress of labour.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
weeenregistratie tijdens bevalling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Aim of pilot study: To prove that the new SMM
sensor detect contraction, especially in the obese population at least similair
to the conventional TDM. Aim of the validation studie: To prove that the new
SMM sensor will detect contraction, especially in the obese population at least
similair to the golden standard IUP sensor.
Secondary outcome
see above
Background summary
Uterine contractions (during labour) can be visualised by a non-invasive
tocodynamometer (TDM) or intra-uterine pressure sensor (IUP). The latter is an
invasive procedure and does not reduce pregnancy outcome. External monitoring
has, however, its limitations, especially in obesese patients. Furthermore,
current non-invasive tocodynamometry cannot register the contration force. A
better external registration of uterine contraction force in normal and
especially obese patients should enhance the treatment of labouring women
Study objective
To study whether an existing sensor device containing motion/orientation
sensors (SMM; Senior Mobility Monitor) can be used to observe progress of
labour.
Study design
Prospective pilot and validation study
Intervention: Simultanous registration of progress of labour with a new
(CE-approved) external motion/orientation sensor (SMM) and the conventional
external tocodynamometer (TDM, pilot study) and simultanous registration with
an intra-uterine pressure device (IUP, validation study)
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Both conventional methods, IUP and TDM are used
in common obstetrical practice. There is a small additional risk in using an
IUP catheter compare to external monitoring. The SMM sensor is either attached
to the extrernal TDM or in case of IUP sensor use placed in the same manner as
the TDM and will therefore not lead to extra burden for the participants.
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
Singleton pregnancy
term pregnancy (gestational age at least 37 weeks
maternal age above 18 yeard at moment of inclusion
Exclusion criteria
plannend Caesarean Section
HELLP-syndrome
Severe intra uterine growth restriction in which induction of labour is indicated
known congenital anomalies
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 | NL46211.099.13 |