To evaluate the effectivity of the electrohysterogram (EHG) by means of a tocopatch electrode compared to tocodynamometry by means of an external tocodynamometer or intrauterine pressure catheter (IUPC) to monitor trial of labour (TOL) in patients…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of succesful trials of labour
Secondary outcome
Admittance to NICU
perinatal mortality
maternal morbidity
costs
Background summary
Avoiding the morbidity of repeat caesarean section through vaginal birth after
caesarean (VBAC) is an attractive option in a majority of women. Moreover the
costs of a vaginal birth are much less than the costs of a caesarean section.
However, the success rate of TOL is low. Tocodynamometry is currently used as
monitoring technique. The test properties of tocodynamometry are poor and the
technique is invasive (IUPC). An innovative technique, electrohysterography
(EHG), is developed and extensively evaluated in a collaboration between TU/e
and MMC. The advantage of EHG is that it is non-invasive,
accurate, and applicable on a continuous basis.
Study objective
To evaluate the effectivity of the electrohysterogram (EHG) by means of a
tocopatch electrode compared to tocodynamometry by means of an external
tocodynamometer or intrauterine pressure catheter (IUPC) to monitor trial of
labour (TOL) in patients with one previous caesarean section (c.section) in
order to increase the VBAC rate without increasing the risk of uterine rupture.
Study design
Multicentre randomised clinical trial
Study burden and risks
The tocopatch is a non-invasive method, from which minimal risks are expected.
The extent of the burden associated with participation is minimal. It is
necesarry to use this population for this study, because of the objects of this
study.
Postbus 90052
5600 PD Eindhoven
NL
Postbus 90052
5600 PD Eindhoven
NL
Listed location countries
Age
Inclusion criteria
Prior caesarean sectio
Singleton pregnancy
Exclusion criteria
previous uterine rupture
intrauterine fetal death
breech presentation
2 or more prior caesarean sections
multiple pregnancy
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 | NL36116.015.11 |