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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 13, 2008 | ||||||||
| Last Updated Date | November 2, 2009 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in heat pain threshold and tolerance [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00699595 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hormonal Effects on Pain Perception | ||||||||
| Official Title ICMJE | Hormonal Effects on Pain Perception | ||||||||
| Brief Summary | To investigate if labor pain is affected by mother's hormone levels. The hormonal effects of pregnancy are well documented. Although differences in pain sensitivity between women and men are partly attributable to social conditioning and to psychosocial factors, many laboratory studies of humans have described sex differences in sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such differences. Some animal studies have suggested that sensitivity to pain decreases during pregnancy because of the progressive activation of endogenous pain inhibitory systems. This effect may be mediated by pregnancy-associated hormones, in particular progesterone. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | Healthy women scheduled for elective Cesarean section. | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | September 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 19 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00699595 | ||||||||
| Responsible Party | Michael Froelich, MD, University at Alabama at Birmingham | ||||||||
| Study ID Numbers ICMJE | F070721003 | ||||||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||||||
| Verification Date | November 2009 | ||||||||
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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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