The following hypotheses will be tested:Hypothese a: Remifentanil PCA gives a better labour satisfaction than pethidine/meperidine i.m.Hypothese b: Remifentanil PCA gives a better pain-relief during labour, than pethidine/meperidine intramuscularly.…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient satisfaction
Secondary outcome
Safety for mother and child including: maternal saturation, respiratory rate
and bloodpressure, neonatal Apgar scores and saturation.
Painrelief, measured by maternal VAS-scores.
Background summary
Good pain relief during labour is important. Current methods are
meperidine/pethidine intramuscularly or epidural analgesia. To overcome the
side effects of both methods, new ways of peripartum painrelief are sought. The
short-acting opiod remifentanil i.v. seems a good alternative.
Study objective
The following hypotheses will be tested:
Hypothese a: Remifentanil PCA gives a better labour satisfaction than
pethidine/meperidine i.m.
Hypothese b: Remifentanil PCA gives a better pain-relief during labour, than
pethidine/meperidine intramuscularly.
Hypothese c: Remifentanil PCA has less disadvantages for the newborn than
pethidine/meperidine i.m.
Hypothese d: Remifentanil PCA has as much disadvantages for the parturient as
pethidine/meperidine i.m.
Study design
a prospective randomised study
Intervention
Group A: painrelief with Remifentanil i.v. using PCA
Group B: painrelief with Pethidine i.m. (= standard treatment)
Study burden and risks
Possible side effects of Remifentanil are reduced ventilatory rate or apnea
with or without reduced oxygen saturation. The elimination half time of
Remifentanil is short. Normal breathing is expected to return within 5 to 10
minutes from the last infusion. An algorithm was made for how to act in case of
desaturation. Midwifes were trained to use the algorithm.
Maelsonstraat 3,
1624 NP Hoorn
Nederland
Maelsonstraat 3,
1624 NP Hoorn
Nederland
Listed location countries
Age
Inclusion criteria
Pregnant and ASA1, women in labor in Westfries gasthuis, planned vaginal delivery, informed consent parturient, a term pregnancy (37+0 till 42+0 weeks), unborn lies in head-down-position, the unborn has no congenital abnormalities
Exclusion criteria
Pregnant woman requesting epidural analgesia or undergoing epidural analgesia, pregnancy is not a term (<37+0 or >42+0 weeks), kwown allergie for remifentanil, paturient who feels she does not have right amount of time to consider enrolling in this study, other fetal positions than head down, fetal congenital abnormalities
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 | EUCTR2007-000736-10-NL |
| CCMO | NL16109.094.07 |