Back to resultsEffect of Fentanyl on Pain Severity and Duration of Labor
Primary Purpose
Decrease Labor Pain
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fentanyl
Sponsored by
About this trial
This is an interventional supportive care trial for Decrease Labor Pain focused on measuring Fentanyl, analgesia, duration of the active phase, pain severity
Eligibility Criteria
Inclusion Criteria:
- multiparas pregnant women (gravid 2-7),
- term singleton pregnancy,
- cephalic presentation,
- low risk pregnancy with no history of drug tolerance (addiction),
- medical and mental diseases.
Exclusion Criteria:
- Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fentanyl
Without Fentanyl
Arm Description
In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour. In control group was not intervention.
The control group did not receive Fentanyl.
Outcomes
Primary Outcome Measures
decrease pain and duration of the active phase considerably.
Secondary Outcome Measures
Full Information
NCT ID
NCT01648595
First Posted
July 17, 2012
Last Updated
July 23, 2012
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01648595
Brief Title
Effect of Fentanyl on Pain Severity and Duration of Labor
Official Title
Principal Investigator
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2006 (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain of delivery. It is necessary to be known effect of these drugs on the mother and fetus during labor adverse. Therefore, the purpose of this study was determination of effect of Fentanyl intravenously on pain severity during the active phase of labor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decrease Labor Pain
Keywords
Fentanyl, analgesia, duration of the active phase, pain severity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl
Arm Type
Experimental
Arm Description
In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour. In control group was not intervention.
Arm Title
Without Fentanyl
Arm Type
No Intervention
Arm Description
The control group did not receive Fentanyl.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour after being diluted in 4 cc normal saline
Primary Outcome Measure Information:
Title
decrease pain and duration of the active phase considerably.
Time Frame
up to 8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
37 Years
Eligibility Criteria
Inclusion Criteria:
multiparas pregnant women (gravid 2-7),
term singleton pregnancy,
cephalic presentation,
low risk pregnancy with no history of drug tolerance (addiction),
medical and mental diseases.
Exclusion Criteria:
Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).
12. IPD Sharing Statement
Learn more about this trial
Effect of Fentanyl on Pain Severity and Duration of Labor
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