NCT00296751

Brief Summary

60 female that care for pain control during second stage of delivery, will choose between epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the second stage for 10 minutes. 30 minutes after administration of either pain relief, a second recording of maternal ECG will take place for 10 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 1, 2010

Status Verified

April 1, 2008

Enrollment Period

9 months

First QC Date

February 24, 2006

Last Update Submit

June 30, 2010

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.

Interventions

ECG recordingPROCEDURE
Epidural catheter insertionPROCEDURE
Intravenous meperidine injectionDRUG
Epidural Bupivacaine and fentanyl injectionDRUG

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam - health care campus

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Amir Weissman, MD

    Rambam Health Care Campus

    STUDY DIRECTOR

  • Olga Torchov, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

July 1, 2010

Record last verified: 2008-04

Locations

IL(1)