Alleviation of labour pain by epidural or spinal analgetic

Phase 1

• Conditions: abour pain; MedDRA version: 18.1Level: LLTClassification code 10023554Term: Labour pains stoppedSystem Organ Class: 100000004868; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-000486-23-FI
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-14
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Primiparous parturients
In early phase of labour (cervical dilatation at or under 5 cm)
No prior opioids by any route of administration within past 120 min
Pain at or over 80 mm on 0-100 mm visual analog scale during contraction
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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergy for any of the medications used
Contraindications for epidural/spinal analgesia
BMI at the time of delivery under 20 or over 35 kg/m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified