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Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour

Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03344042
Enrollment
300
Registered
2017-11-17
Start date
2017-12-01
Completion date
2018-12-20
Last updated
2018-12-06

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

Conditions

Anesthesia, Epidural, Labor Pain, Opioid

Brief summary

Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.

Interventions

DRUGFentanyl

100mcg Fentanyl

DRUGSufentanil

10mcg sufentanil

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participant not aware of opioid administered

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* parturient in labour without cervical dilation and regular uterine contractions

Exclusion criteria

* no consent * known allergy to administered opioid * contraindications to epidural analgesia * coagulopathies including platelet count of less than 100,000 * spine surgery in past

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity according to Numerical Rating Scale (NRS)up to 24 hourstill 4cm cervical dilation in primigravida or 3cm multiparous

Secondary

MeasureTime frameDescription
Fetal heart rateup to 24 hourstill 4cm cervical dilation in primigravida or 3cm multiparous
Blood pressure parturientup to 24 hourstill 4cm cervical dilation in primigravida or 3cm multiparous
Heart rate of parturientup to 24 hourstill 4cm cervical dilation in primigravida or 3cm multiparous

Countries

Poland

Contacts

Primary ContactJan Bilawicz, MD
bilawicz@wp.pl0048225830381

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026