HealthyPOSİTİONNCT06538545
The Effect Of Sitting Position On The Labor Process
A study testing Sitting position is used in Experimental Arms 1-2 in people with Healthy and Bleeding, run by Cumhuriyet University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Sitting position is used in Experimental Arms 1-2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 May 2022to 4 Apr 2024
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hilal Güveri
Sivas, Sivas Merkez, 58000
Cumhuriyet Üniversitesi
Sivas, 58000
About this study
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.
- Being tested
- Sitting position is used in Experimental Arms 1-2
- Keywords
- Bleeding, pregnant, labor duration, pain, Sitting Position
- Medical subject headings
- Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting position is used in Experimental Arms 1-2Behavioural
Also called Lithotomy position is used in those with Active Comparison Arm 3-4.
sitting position Comparison of sitting position and lithotomy position in labor
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:Vertical Position (Experimental Group-Primiparous) | Experimental | 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. Receives: Behavioral: Sitting position is used in Experimental Arms 1-2 |
| Arm 2: Vertical Position (Experimental Group-Multiparous) | Experimental | 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. Receives: Behavioral: Sitting position is used in Experimental Arms 1-2 |
| Arm 3: Lithotomy Position (Control Group-Primiparous) | Active comparator | 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. Receives: Behavioral: Sitting position is used in Experimental Arms 1-2 |
| Arm 4: Lithotomy Position (Control Group-multiparous) | Active comparator | 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. Receives: Behavioral: Sitting position is used in Experimental Arms 1-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The effect of sitting positions of pregnant women in the 38-42nd weeks of pregnancy on the birth process
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start2 May 2022
- Primary completion2 Nov 2022
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Guveri, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538545
- Sponsor's protocol ID
- 2022-04/01
- Acronym
- POSİTİON
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Sitting Position On The Labor Process
- ClinicalTrials.gov ID
- NCT06538545
- Acronym / sponsor ID
- POSİTİON / 2022-04/01
- Keywords
- Bleeding, pregnant, labor duration, pain, Sitting Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 5 Aug 2024 (actual)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1:Vertical Position (Experimental Group-Primiparous) | Experimental | Behavioral: Sitting position is used in Experimental Arms 1-2All 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. |
| Arm 2: Vertical Position (Experimental Group-Multiparous) | Experimental | Behavioral: Sitting position is used in Experimental Arms 1-2All 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. |
| Arm 3: Lithotomy Position (Control Group-Primiparous) | Active comparator | Behavioral: Sitting position is used in Experimental Arms 1-2All 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. |
| Arm 4: Lithotomy Position (Control Group-multiparous) | Active comparator | Behavioral: Sitting position is used in Experimental Arms 1-2The 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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Sitting position is used in Experimental Arms 1-2Also: Lithotomy position is used in those with Active Comparison Arm 3-4.sitting position Comparison of sitting position and lithotomy position in labor | Behavioural | Arm 1:Vertical Position (Experimental Group-Primiparous), Arm 2: Vertical Position (Experimental Group-Multiparous), Arm 3: Lithotomy Position (Control Group-Primiparous), Arm 4: Lithotomy Position (Control Group-multiparous) |
Primary outcome
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
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 7 Aug 2024.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting position is used in Experimental Arms 1-2 in people with Healthy and Bleeding, run by Cumhuriyet University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
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). 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 7 Aug 2024.