Effect of Fentanyl on Pain Severity and Duration of Labor

NCT ID: NCT01648595

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decrease Labor Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fentanyl analgesia duration of the active phase pain severity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fentanyl

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

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

Without Fentanyl

The control group did not receive Fentanyl.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fentanyl

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

21 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nahid Jahani Shoorab

Faculty of Midwifery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Effect of Fentanyl

Identifier Type: -

Identifier Source: org_study_id