Third Stage of LaborNCT00826735
The Effect of Guided Imagery on the Third Stage of Labor
A study testing Guided imagery in people with Third Stage of Labor and Bleeding, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Third Stage of Labor, Bleeding, Guided Imagery
- What is being tested?
- Guided imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years of age or older but less than 35 years
- English as her primary language
- fetus in a cephalic presentation
- singleton pregnancy
- 36 to 38 estimated gestational weeks
- no contraindications to vaginal delivery
- maternal weight less than 200 pounds prior to pregnancy
Who cannot join
- more than four previous children
- a history of postpartum hemorrhage
- bleeding disorder
- seizure disorder
- polyhydramnios
- diabetes (including gestational)
Show all 11Show fewer
- hypertension
- cardiac disease
- uterine fibroids
- anemia (hematocrit less than 30)
- intrauterine fetal demise or tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37240
About this study
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.
- Conditions
- Third Stage of Labor, Bleeding, Guided Imagery, Childbirth
- Being tested
- Guided imagery
- Keywords
- third stage of labor, bleeding, guided imagery, childbirth
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imageryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Guided imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss
Secondary outcomes (1)
Length of third stage of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Stage of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau International, Iota chapter, Sigma Theta Tau International, Delta Psi chapter, American College of Nurse-Midwive - ACNM Foundation
- Investigators
- Mavis N Schorn, PhD, Principal investigator, Vanderbilt University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826735
- Sponsor's protocol ID
- 070035
- Status last verified
- Jan 2009
- First submitted
- 20 Jan 2009
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery on the Third Stage of Labor
- ClinicalTrials.gov ID
- NCT00826735
- Acronym / sponsor ID
- 070035
- Conditions
- Third Stage of Labor, Bleeding, Guided Imagery, Childbirth
- Keywords
- third stage of labor, bleeding, guided imagery, childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Sigma Theta Tau International, Iota chapter, Sigma Theta Tau International, Delta Psi chapter, American College of Nurse-Midwive - ACNM Foundation
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided imagery | Experimental | Behavioral: Guided imageryThe 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 years of age or older but less than 35 years
- English as her primary language
- fetus in a cephalic presentation
- singleton pregnancy
- 36 to 38 estimated gestational weeks
Key exclusion criteria (11 listed)
- more than four previous children
- a history of postpartum hemorrhage
- bleeding disorder
- seizure disorder
- polyhydramnios
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided imageryA 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. | Behavioural | Guided imagery |
Primary outcome
Blood Loss
1 secondary outcome
Length of third stage of labor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mavis N Schorn, PhD principal investigator
Vanderbilt University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided imagery in people with Third Stage of Labor and Bleeding, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2009.