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Hormonal Effects on Pain Perception (HEPP)

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ClinicalTrials.gov Identifier: NCT00699595
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : November 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Pregnancy Progesterone Levels Pregnancy Associated Analgesia

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hormonal Effects on Pain Perception
Study Start Date : September 2008
Primary Completion Date : November 2014
Study Completion Date : November 2014
Groups and Cohorts

Group/Cohort
Term pregnant women
Healthy women scheduled for elective Cesarean section.


Outcome Measures

Primary Outcome Measures :
  1. Change in heat pain threshold and tolerance [ Time Frame: 1 month ]

Biospecimen Retention:   None Retained
Plasma for progesterone levels

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy term pregnant women
Criteria

Inclusion Criteria:

  • healthy pregnant women at term (>37GA)

Exclusion Criteria:

  • chronic pain
  • regular analgesic medication
  • severe cardiopulmonary problems
  • very difficult intravenous access
  • advanced labor
  • precipitous delivery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699595


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Michael Froelich, MD, MS University of Alabama at Birmingham
More Information

Responsible Party: Michael Froelich, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00699595     History of Changes
Other Study ID Numbers: F070721003
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014