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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02963337
Date of registration: 07/11/2016
Prospective Registration: Yes
Primary sponsor: University Medical Centre Ljubljana
Public title: Remifentanil vs. Combined Spinal-epidural Analgesia for Labor Analgesia and Progress of Labor in Multiparous
Scientific title: Pain Relief and Progress of Labour With Remifentanil Patient-controlled Analgesia Versus Combined Spinal-epidural Analgesia in Multiparous Women: a Prospective Observational Study
Date of first enrolment: January 1, 2017
Target sample size: 162
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02963337
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Slovenia
Contacts
Name:     Vesna Novak Jankovic, Professor
Address: 
Telephone:
Email:
Affiliation:  University Medical Centre
Key inclusion & exclusion criteria

Inclusion Criteria:

- patients' request for pain relief

- ASA physical status 1-3

- uncomplicated singleton pregnancy with cefalic presentation

- gestation age > 37 weeks

- regular uterine contractions

- cervical dilation 2-5 cm

- anticipated vaginal delivery

- fetus without suspected abnormality and normal CTG

Exclusion Criteria:

- contraindications for remifentanil usage

- contraindications for CSE



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Labor; Prolonged, First Stage
Labor; Prolonged, Second Stage
Labor Pain
Intervention(s)
Drug: combined spinal-epidural analgesia
Drug: remifentanil
Primary Outcome(s)
Pain relief with remifentanil or CSE in multiparous women [Time Frame: two years]
Secondary Outcome(s)
Duration of first and second stage of labor [Time Frame: one year]
Patient satisfaction with pain relief [Time Frame: two years]
Secondary ID(s)
2104
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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