Decrease Labor PainPhase 2/3NCT01648595
Effect of Fentanyl on Pain Severity and Duration of Labor
A Phase 2/3 study testing Fentanyl in people with Decrease Labor Pain, run by Mashhad University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 37 years, women only
- Conditions the study is for
- Decrease Labor Pain
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Sep 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 37 years
- Women only
- Adult
Who may be able to join
- 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.
Who cannot join
- Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).
About this study
Official title: Principal Investigator
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.
- Conditions
- Decrease Labor Pain
- Being tested
- Fentanyl
- Keywords
- Fentanyl, analgesia, duration of the active phase, pain severity
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl |
| Without Fentanyl | No intervention | The control group did not receive Fentanyl. |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease pain and duration of the active phase considerably.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJan 2006
- Primary completionAug 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decrease Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahid Jahani Shoorab, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648595
- Sponsor's protocol ID
- Effect of Fentanyl
- Status last verified
- Jan 2006
- First submitted
- 17 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT01648595
- Acronym / sponsor ID
- Effect of Fentanyl
- Conditions
- Decrease Labor Pain
- Keywords
- Fentanyl, analgesia, duration of the active phase, pain severity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 70 participants
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2006
- Study completion
- Sep 2006
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: FentanylIn case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour. In control group was not intervention. |
| Without Fentanyl | No intervention | –The control group did not receive Fentanyl. |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylIn case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour after being diluted in 4 cc normal saline | Drug | Fentanyl |
Primary outcome
decrease pain and duration of the active phase considerably.
Time frame: up to 8 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fentanyl in people with Decrease Labor Pain, run by Mashhad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease pain and duration of the active phase considerably. (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.