Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC

This study is ongoing, but not recruiting participants.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 20, 2009

Last Updated Date

September 20, 2011

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00867945 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC

Official Title ^ICMJE

Pregnancy-Induced Analgesia - A Longitudinal Study of DNIC

Brief Summary

The investigators hypothesize that pregnancy-induced analgesia might be the result of enhanced descending noxious inhibitory activity.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Biospecimen

Sampling Method

Non-Probability Sample

Study Population

maternity clinic - Pregnant Cohort community sample - Non-pregnant Control Cohort

Condition ^ICMJE

Pregnancy

Intervention ^ICMJE

Study Group/Cohort (s)

1. Pregnant Women
2. Non-Pregnant Controls

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00867945

Other Study ID Numbers ^ICMJE

35811-A

Has Data Monitoring Committee

Responsible Party

Ruth Landau, University of Washington

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

Stanford University

Investigators ^ICMJE

Principal Investigator:

Ruth Landau, MD

University of Washington

Information Provided By

University of Washington

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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