A comparison of pethidine/meperidine intramusculary and remifentanil patient-controlled analgesia during labor in Westfriesgasthuis - PCA remifentanil during labor

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000736-10-NL

Enrollment

260

Registered

2008-09-11

Start date

2007-11-05

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women in labour MedDRA version: 9.1 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnant woman requesting epidural analgesia or undergoing epidural analgesia, pregnancy is not a term (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 outcomes

Primary

Measure	Time frame
Main Objective: - comparison of patient's satisfaction using pethidine/meperidine im and PCA remifentanil for pain relief during labour - is remifentanil safe for paturient and fetus;Secondary Objective: is there a difference in the pain perception of prima para and multi para ;Primary end point(s): Patient satisfaction measured by the women's view of birth labor satisfaction questionnaire, painrelief measured by VAS-scores, parturient and fetal safety	—

Measure

Time frame

Main Objective: - comparison of patient's satisfaction using pethidine/meperidine im and PCA remifentanil for pain relief during labour - is remifentanil safe for paturient and fetus;Secondary Objective: is there a difference in the pain perception of prima para and multi para ;Primary end point(s): Patient satisfaction measured by the women's view of birth labor satisfaction questionnaire, painrelief measured by VAS-scores, parturient and fetal safety

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026