- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06538545
The Effect Of Sitting Position On The Labor Process (POSİTİON)
August 5, 2024 updated by: Hilal Guveri, Cumhuriyet University
This study was conducted to determine the effect of sitting position on the labor process.
The randomized controlled experimental study was conducted in the delivery room of Sivas Numune Hospital.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sivas, Turkey, 58000
- Cumhuriyet Universitesi
-
-
Sivas Merkez
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Sivas, Sivas Merkez, Turkey, 58000
- Hilal Güveri
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age range: 19-35
- 38-42 weeks of pregnancy
- No health problems that would prevent the use of sitting position
- -Amniotic membranes not ruptured
- Having a singleton pregnancy
- Fetus in vertex position
- Labor occurs with normal spontaneous vaginal delivery
- No diagnosed chronic physical disease
- No diagnosed psychiatric disease
- No risky pregnancy, risky delivery and newborn/fetus
- No communication problems
- Voluntarily participating in the research
Exclusion Criteria:
- Only women who gave birth at Sivas Sample Hospital were included in the study
- Women who gave birth more than two times were not included in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1:Vertical Position (Experimental Group-Primiparous)
All pregnant women in the experimental group were allowed to use a sitting position (sitting and rocking on a pilates ball or sitting on a bed) from the active phase until labor.
They were allowed to lie down for 10-15 minutes when they were tired or when monitoring or intervention was needed.
|
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
|
|
Experimental: Arm 2: Vertical Position (Experimental Group-Multiparous)
All pregnant women in the experimental group were allowed to use a sitting position (sitting and rocking on a pilates ball or sitting on a bed) from the active phase until labor.
They were allowed to lie down for 10-15 minutes when they were tired or when monitoring or intervention was needed.
|
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
|
|
Active Comparator: Arm 3: Lithotomy Position (Control Group-Primiparous)
All pregnant women in the control group were followed up with hospital procedures during labor.
From the latent phase until labor, the pregnant woman was followed up with hospital procedures.
At the end of the latent and active phases, pain assessment was requested and VAS (Appendix 6) was applied.
The 2nd and 3rd stages of labor were performed on a normal delivery table in the lithotomy position.
|
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
|
|
Active Comparator: Arm 4: Lithotomy Position (Control Group-multiparous)
The hospital procedure was applied to determine the birth rates of all pregnant women in the control group.
From the latent stage until the birth, the pregnant woman is followed up by applying the hospital procedure.
At the end of the latent and active phases, the alarm results were requested to be evaluated and VAS (Appendix 6) was developed.
The 2nd and 3rd stages of labor were performed in the lithotomy positions on the normal delivery table.
|
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale is applied starting from the 1st stage of labor and until the end of the 2nd stage.If the VAS value is 10, it means there is a lot of pain, and if it is 0, it means there is no pain.
Time Frame: 1 years
|
The effect of sitting positions of pregnant women in the 38-42nd weeks of pregnancy on the birth process
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2022
Primary Completion (Actual)
November 2, 2022
Study Completion (Actual)
April 4, 2024
Study Registration Dates
First Submitted
July 24, 2024
First Submitted That Met QC Criteria
August 2, 2024
First Posted (Actual)
August 5, 2024
Study Record Updates
Last Update Posted (Actual)
August 7, 2024
Last Update Submitted That Met QC Criteria
August 5, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-04/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Yes: There is a plan to make IPD and related data dictionaries available.
IPD Sharing Time Frame
1 years
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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