Status:
UNKNOWN
Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Stanford University
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Brief Summary
The investigators hypothesize that pregnancy-induced analgesia might be the result of enhanced descending noxious inhibitory activity.
Detailed Description
Pregnancy-induced analgesia has been described in several studies (Gintzler 1980; Sander and Gintzler 1987; Jarvis et al. 1997). Obvious mechanisms underlying pregnancy-induced analgesia involve hormo...
Eligibility Criteria
Inclusion
- Pregnant Cohort: Inclusion criteria for participation are (1) women aged between 18 and 45 yr, (2) nulliparous or ASA physical status class I or II women, (3) singleton pregnancy, (4) no more than 14 completed weeks gestational age at the time of enrollment into the study, (5) uncomplicated pregnancy, and (6) delivery planned to be conducted at UW/Stanford University.
- Non-pregnant Control Cohort: Inclusion criteria for participation are (1) women aged between 18 and 45 yr, (2) nulliparous or ASA physical status class I or II women, (3) and not planning on taking oral-contraceptives or carrying a hormonal-coated IUD.
- Non-inclusion Criteria:
- Pregnant Cohort: Non-inclusion criteria are (1) multiparous women, (2) non-English speaking women (subjects have to be able to understand the DNIC procedure and answer questionnaires), (3) women unable to understand the concept of VNPS at the time of informed consent (involving mental health issues), (4) a history of anxiety or depression, or chronic consumption of opiates, antidepressants, or anticonvulsants; and (5) intake of opioids, acetaminophen, or NSAIDs 48h prior to the psychophysical test.
- Non-pregnant Control Cohort: Non-inclusion criteria are the same as the Pregnant Cohort as well as (6) irregular menstrual cycles (defined as \< 21 days or \> 35 days).
Exclusion
- Pregnant Cohort: Exclusion criteria is a pregnancy complicated by preeclampsia or preterm delivery (\< 37 weeks gestation).
- Non-pregnant Control Cohort: Exclusion criteria is development of irregular cycles.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00867945
Start Date
March 1 2009
End Date
December 1 2013
Last Update
June 19 2013
Active Locations (2)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
University of Washington
Seattle, Washington, United States, 98195-6540