LaborNCT05708482
Sling and Swing Positions to Pregnant Women
A study testing Sling-Swing Position in people with Labor and Parturition, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
It is an experimental and randomized controlled study planned to evaluate the effect of sling-swinging position on the birth experience in vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Parturition, Delivery
- What is being tested?
- Sling-Swing Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2022to 30 Sep 2023
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- According to Robson scoring, the midwife can follow the birth process.
- Pregnant women who are in the active phase of the first stage of labor
Who cannot join
- It was decided to deliver by cesarean section due to any indication.
- Pharmacological approach applied
- Any maternal-fetal complication developed
- Those with a height of 150 cm and below
- Pregnant women who want to quit working
- Excluding the inclusion criteria
- Does not know Turkish language (reading-writing-speaking-listening)
- Pregnant women diagnosed with mental and/or auditory disabilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital- Maternity Hospital
Ankara, Çankaya
About this study
Official title: Evaluation of the Effect of Sling and Swing Positions to Pregnant Women in Labour on the Labour Process and Birth Outcomes
It is an experimental and randomized controlled study planned to evaluate the effect of sling-swinging position on the birth experience in vaginal delivery.
Read the detailed description
In the sample calculation of the study, the sufficient sample size to be studied with a power of 95% based on d=0.8 (large) effect size alpha=0.05 was calculated using the G*Power 3.1.9.4 program, 35 for the application group and 35 for the control group, a total of 70 people.
According to Robson scoring, the midwife can follow the birth process and Pregnant women who are in the active phase of the first stage of labor (5 cm cervical dilatation) are inclusion criterias.
In the study, data have been collected using Introductory Information and Birth Process Follow-up Form and Postpartum Satisfaction Form were developed by the researchers.
For intervention group:
- While the pregnant woman has 6 cm cervical dilatation examination, the flexible fabric will pass under the arms of the pregnant woman to form a hanger shape. The pregnant woman will be asked to hold the fabric on her feet in a squat and the hanging technique will be applied for 10 minutes. Then, a swing shape will be created in such a way that the flexible fabric will wrap around the chest area of the pregnant woman. The pregnant woman will be asked to hold the fabric in a squat above the knee and the rocking technique will be applied for 10 minutes. The comfort of the pregnant woman will be questioned throughout the procedure. Subsequently, uterine contractions, fetal heart rate, fetal head level, position and presence of molding will be evaluated.
- Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), the pregnant will be held in the hanging position for 10 minutes and rocking position for 10 minutes, once an hour. Uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated after each application, hourly.
For control group:
- While the pregnant woman has 6 cm cervical dilatation examination, uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated.
- Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated every hour.
For Each Group:
A Birth Satisfaction Form will be filled at the 2nd hour after delivery. At the end of the study, delivery times and satisfaction of pregnant women will be analyzed.
- Conditions
- Labor, Parturition, Delivery
- Being tested
- Sling-Swing Position
- Keywords
- delivery duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sling-Swing PositionOther
The device is hammock which look likes a rope
| Study group | Role | What they receive |
|---|---|---|
| Sling-Swing Group | Experimental | 1. While the pregnant woman has 6 cm cervical dilatation examination, the flexible fabric will pass under the arms of the pregnant woman to form a hanger shape. The pregnant woman will be asked to hold the fabric on her feet in a squat and the hanging technique will be applied for 10 minutes. Then, a swing shape will be created in such a way that the flexible fabric will wrap around the chest area of the pregnant woman. The pregnant woman will be asked to hold the fabric in a squat above the knee and the rocking technique will be applied for 10 minutes. Subsequently, uterine contractions, fetal heart rate, fetal head level, position and presence of molding will be evaluated.
2. Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), this applicant will be experienced by them as the same procedure, hourly.
3. A Birth Satisfaction Form will be filled at the 2nd hour after delivery.. Receives: Other: Sling-Swing Position |
| Standard Care Group | No intervention | 1. While the pregnant woman has 6 cm cervical dilatation examination, uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated. 2. Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated every hour. 3. A Birth Satisfaction Form will be filled at the 2nd hour after delivery. At the end of the study, delivery times and satisfaction of pregnant women will be analyzed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Labor
It is about time as a minute
Measured: during labor process
Satisfaction of Labor
It is about a point which is evaluated by using form. This simple form was developed by researchers. It has five state and its maximum point is 25 and minimum point is 5. The satisfaction increases, the point increases.
Measured: postpartum second hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start30 Sep 2022
- Primary completion30 May 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Principal investigator, Nükhet Kaçar, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708482
- Sponsor's protocol ID
- AnkaraCHBilkent-MH-NK
- Status last verified
- Dec 2023
- First submitted
- 23 Jan 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is about the ethical process.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Sling and Swing Positions to Pregnant Women in Labour on the Labour Process and Birth Outcomes
- ClinicalTrials.gov ID
- NCT05708482
- Acronym / sponsor ID
- AnkaraCHBilkent-MH-NK
- Conditions
- Labor, Parturition, Delivery
- Keywords
- delivery duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Feb 2023 (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.
It is an experimental and randomized controlled study planned to evaluate the effect of sling-swinging position on the birth experience in vaginal delivery.
Detailed description
In the sample calculation of the study, the sufficient sample size to be studied with a power of 95% based on d=0.8 (large) effect size alpha=0.05 was calculated using the G*Power 3.1.9.4 program, 35 for the application group and 35 for the control group, a total of 70 people.
According to Robson scoring, the midwife can follow the birth process and Pregnant women who are in the active phase of the first stage of labor (5 cm cervical dilatation) are inclusion criterias.
In the study, data have been collected using Introductory Information and Birth Process Follow-up Form and Postpartum Satisfaction Form were developed by the researchers.
For intervention group:
- While the pregnant woman has 6 cm cervical dilatation examination, the flexible fabric will pass under the arms of the pregnant woman to form a hanger shape. The pregnant woman will be asked to hold the fabric on her feet in a squat and the hanging technique will be applied for 10 minutes. Then, a swing shape will be created in such a way that the flexible fabric will wrap around the chest area of the pregnant woman. The pregnant woman will be asked to hold the fabric in a squat above the knee and the rocking technique will be applied for 10 minutes. The comfort of the pregnant woman will be questioned throughout the procedure. Subsequently, uterine contractions, fetal heart rate, fetal head level, position and presence of molding will be evaluated.
- Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), the pregnant will be held in the hanging position for 10 minutes and rocking position for 10 minutes, once an hour. Uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated after each application, hourly.
For control group:
- While the pregnant woman has 6 cm cervical dilatation examination, uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated.
- Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated every hour.
For Each Group:
A Birth Satisfaction Form will be filled at the 2nd hour after delivery. At the end of the study, delivery times and satisfaction of pregnant women will be analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sling-Swing Group | Experimental | Other: Sling-Swing Position1. While the pregnant woman has 6 cm cervical dilatation examination, the flexible fabric will pass under the arms of the pregnant woman to form a hanger shape. The pregnant woman will be asked to hold the fabric on her feet in a squat and the hanging technique will be applied for 10 minutes. Then, a swing shape will be created in such a way that the flexible fabric will wrap around the chest area of the pregnant woman. The pregnant woman will be asked to hold the fabric in a squat above the knee and the rocking technique will be applied for 10 minutes. Subsequently, uterine contractions, fetal heart rate, fetal head level, position and presence of molding will be evaluated. 2. Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), this applicant will be experienced by them as the same procedure, hourly. 3. A Birth Satisfaction Form will be filled at the 2nd hour after delivery.. |
| Standard Care Group | No intervention | –1. While the pregnant woman has 6 cm cervical dilatation examination, uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated. 2. Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated every hour. 3. A Birth Satisfaction Form will be filled at the 2nd hour after delivery. At the end of the study, delivery times and satisfaction of pregnant women will be analyzed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- According to Robson scoring, the midwife can follow the birth process.
- Pregnant women who are in the active phase of the first stage of labor
Key exclusion criteria (8 listed)
- It was decided to deliver by cesarean section due to any indication.
- Pharmacological approach applied
- Any maternal-fetal complication developed
- Those with a height of 150 cm and below
- Pregnant women who want to quit working
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 |
|---|---|---|
| Sling-Swing PositionThe device is hammock which look likes a rope | Other | Sling-Swing Group |
Primary outcome
Duration of Labor
Time frame: during labor process
It is about time as a minute
Satisfaction of Labor
Time frame: postpartum second hour
It is about a point which is evaluated by using form. This simple form was developed by researchers. It has five state and its maximum point is 25 and minimum point is 5. The satisfaction increases, the point increases.
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 21 Dec 2023.
- Individual participant dataSharing planned: No. It is about the ethical process.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sling-Swing Position in people with Labor and Parturition, run by Ankara City Hospital Bilkent at 1 site 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?
The sponsor lists 2 inclusion and 8 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 21 Dec 2023. 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 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?
Duration of Labor (time frame: during labor process). The study lists 2 primary outcomes in all. 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 21 Dec 2023.