NCT01012466

Brief Summary

The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. Other studies have shown that women who experience intense pain in the earliest stages of labor have a higher risk of complications. The investigators want to know if negative thoughts can predict this outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

November 12, 2009

Last Update Submit

July 24, 2019

Conditions

Pregnancy

Keywords

pregnancybirthlaborlabor paincatastrophizing

Outcome Measures

Primary Outcomes (1)

  • Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms)

    Immediate postpartum

Secondary Outcomes (2)

  • Relationship between pain catastrophizing and reported pain in labor

    1 day postpartum and 4-8 weeks postpartum

  • Relationship between pain catastrophizing and satisfaction with birth experience and care

    1 day postpartum and 4-8 weeks postpartum

Eligibility Criteria

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

Nulliparous women attending the prenatal clinic at Oregon Health \& Science University

You may qualify if:

  • At least 20 weeks of pregnancy
  • Nulliparous
  • Singleton pregnancy
  • Low risk pregnancy

You may not qualify if:

  • Primiparous and multiparous women
  • Women who request cesarean delivery
  • Women who are pregnant with twins
  • Women who plan induction
  • Women who deliver before 37 weeks
  • Women enrolled in the "Centering Pregnancy" program at the Family Birth Center
  • High risk pregnancies
  • Severe mental illness that impairs cognition or function
  • Suicidal ideation
  • Women who do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Beth Darnall, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations

US(1)