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Hormonal Effects on Pain Perception (HEPP)

This study is currently recruiting participants.
Verified June 2012 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00699595
First received: June 13, 2008
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Pregnancy
Progesterone Levels
Pregnancy Associated Analgesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hormonal Effects on Pain Perception

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in heat pain threshold and tolerance [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Plasma for progesterone levels


Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Term pregnant women
Healthy women scheduled for elective Cesarean section.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699595

Contacts
Contact: Michael Froelich, MD, MS 205-975-0145 froelich@uab.edu
Contact: Alice Esame, BS BIology 205-934-4711 alicee@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alice Esame, BS Biology     205-934-4711     alicee@uab.edu    
Principal Investigator: Michael Froelich, MD, MS            
Sub-Investigator: Brian T. Torgerson, MD            
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Michael Froelich, MD, MS University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Michael Froelich, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00699595     History of Changes
Other Study ID Numbers: F070721003
Study First Received: June 13, 2008
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013