NCT00826735

Brief Summary

The purpose of this study was to evaluate the effect of guided imagery on the third stage of labor. Blood loss from hemorrhage during childbirth, most commonly due to uterine atony, is one of the leading causes of maternal mortality in the United States and the leading cause of maternal death worldwide. The hypothesis was that the use of physiologic guided imagery would reduce the amount of bleeding during the third stage of labor.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

11 months

First QC Date

January 20, 2009

Last Update Submit

January 21, 2009

Conditions

Keywords

third stage of laborbleedingguided imagerychildbirth

Outcome Measures

Primary Outcomes (1)

  • Blood Loss

Secondary Outcomes (1)

  • Length of third stage of labor

Study Arms (1)

Guided imagery

EXPERIMENTAL

The experimental group received a relaxation focused guided imagery intervention to use through the remainder of pregnancy plus a physiologic guided imagery intervention during the third stage of labor. These interventions were scripted and prerecorded on CDs.

Behavioral: Guided imagery

Interventions

Guided imageryBEHAVIORAL

A relaxation focused guided imagery intervention was used through the remainder of pregnancy plus a physiologic guided imagery intervention was used during the third stage of labor.

Guided imagery

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age or older but less than 35 years
  • English as her primary language
  • fetus in a cephalic presentation
  • singleton pregnancy
  • to 38 estimated gestational weeks
  • no contraindications to vaginal delivery
  • maternal weight less than 200 pounds prior to pregnancy

You may not qualify if:

  • more than four previous children
  • a history of postpartum hemorrhage
  • bleeding disorder
  • seizure disorder
  • polyhydramnios
  • diabetes (including gestational)
  • hypertension
  • cardiac disease
  • uterine fibroids
  • anemia (hematocrit less than 30)
  • intrauterine fetal demise or tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mavis N Schorn, PhD

    Vanderbilt University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations