- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03980951
Neuroaxial Labour Analgesia
March 20, 2020 updated by: Wahba bakhet
A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural
The secondary objective of this study is to compare the and fetomaternal outcomes
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Nulliparous parturient
- Singleton, vertex gestation at term (37-42 weeks)
- Less than 5 cm dilation
- request an epidural technique for labor analgesia
Exclusion Criteria:
- Hypersensitivity to local the study drugs
- Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
- Any contraindication to the administration of an epidural technique
- Risk factor for cesarean delivery.
- fetal anomalies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: combined spinal epidural group
Bupivacaine 2.5 mg
|
three labor analgesia techniques
|
Active Comparator: dura puncture epidural group
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
|
three labor analgesia techniques
|
Active Comparator: epidural
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
|
three labor analgesia techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
epidural Local anesthetic consumption
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal hypotension
Time Frame: 1 year
|
maternal mean arterial blood pressure less than 50 mmhg
|
1 year
|
incidence of fetal bradycardia
Time Frame: 1 year
|
a fetal heart rate of less than 100 beats per minute
|
1 year
|
incidence of maternal pruritus
Time Frame: 1 year
|
Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe
|
1 year
|
labour pain scores
Time Frame: 1 year
|
Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
June 5, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (Actual)
June 10, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 20, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019 WB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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