NCT00867945

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4.8 years

First QC Date

March 20, 2009

Last Update Submit

June 17, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pregnant Cohort - each trimester and postpartum; Control Cohort - twice a menstrual cycle, 4 cycles, over 7 months

Secondary Outcomes (1)

  • Questionnaires, pain scores, amount of analgesics required, overall experience of labor and delivery

    Questionnaires - Same as Primary Outcome Measure; other three measures - at delivery

Study Arms (3)

1. Pregnant Women

2. Non-Pregnant Controls

3. IVF controls

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

University of Washington

Seattle, Washington, 98195-6540, United States

RECRUITING

Study Officials

  • Ruth Landau, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2009

First Posted

March 24, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations