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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 24, 2006 | ||||||||
| Last Updated Date | April 18, 2008 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00296751 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Epidural Analgesia Versus IV Meperidine for Labor Pain Control | ||||||||
| Official Title ICMJE | Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System. | ||||||||
| 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. |
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| Detailed Description | Population 60 female during second stage of delivery
the parturient will be lying on her left side for that period.
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Other, Randomized, Open Label, Active Control, Parallel Assignment | ||||||||
| Condition ICMJE | Labor Pain | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | December 2006 | ||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: all parturients requiring pain relief will choose between systemic or epidural analgesia. Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular or autonomic system. - |
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| Gender | Female | ||||||||
| Ages | 20 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00296751 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | epiduralCTIL | ||||||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Rambam Health Care Campus | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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