NCT01648595

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
Last Updated

July 24, 2012

Status Verified

January 1, 2006

Enrollment Period

7 months

First QC Date

July 17, 2012

Last Update Submit

July 23, 2012

Conditions

Decrease Labor Pain

Keywords

Fentanylanalgesiaduration of the active phasepain severity

Outcome Measures

Primary Outcomes (1)

  • decrease pain and duration of the active phase considerably.

    up to 8 months

Study Arms (2)

Fentanyl

EXPERIMENTAL

In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour. In control group was not intervention.

Drug: Fentanyl

Without Fentanyl

NO INTERVENTION

The control group did not receive Fentanyl.

Interventions

FentanylDRUG

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

Fentanyl

Eligibility Criteria

Age21 Years - 37 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaPain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Midwifery

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 24, 2012

Study Start

January 1, 2006

Primary Completion

August 1, 2006

Study Completion

September 1, 2006

Last Updated

July 24, 2012

Record last verified: 2006-01