To study the validity of the AN24 monitor for uEMG monitoring of uterine contractions compared to intra-uterine pressure monitoring during labour.
ID
Source
Brief title
Condition
- Maternal complications of labour and delivery
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy of uterine contraction monitoring with uEMG in terms of the
sensitivity, positive predictive value, frequency, duration, and amplitude of
the uterine contractions.
Secondary outcome
not applicable
Background summary
Current techniques for monitoring uterine contractions during labour are either
restricted by their performance (tocodynamometry) or are considered invasive
(intra uterine pressure catheter; IUPC) and could therefore generate a
potential risk for the women in labour. An alternative method uses the uterine
electrical activity to quantify contractions. This method (uterine
electromyography; uEMG) is not only a surrogate for the existing techniques but
might be considered beneficial as it contains new, clinical information on the
quality of contractions. The validity of the uEMG technique has been studied
before, however only small study-populations, or in non-clinical settings. The
objective of the current study is to evaluate the accuracy of AN24 monitor for
the monitoring of uterine contractions during labour by comparing with
intra-uterine pressure catheter measurements.
Study objective
To study the validity of the AN24 monitor for uEMG monitoring of uterine
contractions compared to intra-uterine pressure monitoring during labour.
Study design
Prospective, observational cohort study. Women in early labour receive a
60-minute recording of uterine contractions using five transabdominally placed
electrodes to record the uterine electromyogram (uEMG).
Study burden and risks
The burden is minimal and the risks of this study are to be negligible.
Patients will be asked to perform a simultaneous 60-minute measurement of
uterine contraction monitoring. The intra uterine pressure catheter (IUPC) is
the reference test for uterine contraction monitoring, and has been inserted
prior to giving study information to the woman eligible for this study. Uterine
contractions will be monitored simultaneously using the uEMG signal with the
AN24-monitor (Monica Healthcare, Nottingham). The AN24 has been tested for its
use in the clinical setting by the Department of Medical Technology of the UMCU
(see appendix of protocol) and has received CE marking for electromyographic
recordings of both the fetal- and maternal heart rates, as well as for the
registration of uterine contractions (see appendix of protocol). The use of the
AN24 monitor presents no risks whatsoever for mother or fetus. It is
non-invasive, does not prevent the use of any other diagnostic tools used in
current clinical practice and does not restrict the mobility of women in
labour.
Lundlaan 6
3508 AB Utrecht
Nederland
Lundlaan 6
3508 AB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
> 18 years of age
Gestational age >37 weeks
Singleton pregnancy
Intra uterine pressure monitoring
Exclusion criteria
Multiple pregancy (twin, triplet)
Fetal malformation/chromosomal abnormalities
Active labour
Bad physical condition
Design
Recruitment
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 | NL14824.041.08 |