Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC
This study is ongoing, but not recruiting participants.
Sponsor:
University of Washington
Collaborator:
Stanford University
Information provided by (Responsible Party):
Ruth Landau, University of Washington
ClinicalTrials.gov Identifier:
NCT00867945
First received: March 20, 2009
Last updated: September 20, 2011
Last verified: September 2011
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Purpose
The investigators hypothesize that pregnancy-induced analgesia might be the result of enhanced descending noxious inhibitory activity.
| Condition |
|---|
|
Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC |
Further study details as provided by University of Washington:
Primary Outcome Measures:
- To use psychophysical tests to study both the inhibitory and excitatory pain pathways using the DNIC paradigm and temporal summation longitudinally during pregnancy, compared to an age-matched control group of non-pregnant women. [ Time Frame: Pregnant Cohort - each trimester and postpartum; Control Cohort - twice a menstrual cycle, 4 cycles, over 7 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Questionnaires, pain scores, amount of analgesics required, overall experience of labor and delivery [ Time Frame: Questionnaires - Same as Primary Outcome Measure; other three measures - at delivery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 1. Pregnant Women |
| 2. Non-Pregnant Controls |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
maternity clinic - Pregnant Cohort community sample - Non-pregnant Control Cohort
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867945
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195-6540 | |
Sponsors and Collaborators
University of Washington
Stanford University
Investigators
| Principal Investigator: | Ruth Landau, MD | University of Washington |
More Information
No publications provided
| Responsible Party: | Ruth Landau, Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00867945 History of Changes |
| Other Study ID Numbers: | 35811-A |
| Study First Received: | March 20, 2009 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013