To assess in women with a request for pain relief during labour the cost-effectiveness of remifentanil patient controlled analgesia (RPCA) as first choice compared to EA.
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study will assess in women with a request for pain relief during labour
the cost-effectiveness of RPCA as first choice treatment compared to EA. We
will look at the following outcomes: costs, pain relief scores
(pain-appreciation
Secondary outcome
Maternal and Neonatal Side effects of both strategies.
Background summary
Epidural analgesia (EA) is considered to be the most effective method of pain
relief during labour and is recommended as first method of pain relief by the
Dutch Societies of Gynecologists and Anesthetists. In the Netherlands its
uptake by pregnant women in labour of all ethnicities is still limited (10%),
compared with other western countries (40-80%), mainly as a result of
non-availability due to logistic problems.
Study objective
To assess in women with a request for pain relief during labour the
cost-effectiveness of remifentanil patient controlled analgesia (RPCA) as first
choice compared to EA.
Study design
National multicenter randomized controlled trial (RCT), (university hospitals,
teaching and non-teaching hospitals). In cooperation with midwifery practices.
Study burden and risks
In this study two already widely used methods of pain relief during labour will
be compared. No experimental medication will be used. No additional physical
examination is needed for this study, nor will extra blood be taken from the
subjects.
Already documented risk of remifentanil PCA are maternal respiratory
depression, nausea/vomiting and itching.
Known risks of epidural analgesia are hypotension, increased use of oxytocin
and increased risk of instrumental delivery.
Maternal side effects will be part of the study outcome.
After delivery participating women will be asked to fill out a questionnaire.
Possible benefit is that if RPCA shows to be costeffective as a first choise
treatment compared to EA there will be a much larger availibility of pain
relief in labour.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Age >18 years
Labour between 32-42 weeks of gestation
ASA physical status I or II
Exclusion criteria
Prior administration of regional of opioid analgesia
Drug allergy: history of hypersensitivity to opioid or local anesthetic
substances
Initial maternal SpO2 of less than 95%
Initial maternal temperature of 38C or higher.
Contra-indication for epidural analgesia
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 |
---|---|
EudraCT | EUCTR2010-023319-32-NL |
CCMO | NL34262.058.10 |