Hormonal Effects on Pain Perception (HEPP)

November 8, 2014 updated by: Michael Froelich, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy term pregnant women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in heat pain threshold and tolerance
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 8, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • F070721003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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