Labor LongNCT05276947
The Use of Peanut Ball in Labor in Obese Women
A study testing position with peanut ball in people with Labor Long, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Long
- What is being tested?
- position with peanut ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2022to 13 Aug 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admitted for delivery
- Maternal BMI > 30kg/m2 at admission
- Gestational age > 37 weeks 0 days
- Singleton pregnancy
- Cephalic presentation
- Cervical dilatation less than 5 cm
- Turkish speaking
Who cannot join
- Pre-pregnancy BMI < 30kg/m2
- Gestational age < 37 weeks 0 days
- Multifetal gestation
- Intrauterine fetal demise
- Musculoskeletal problems
- Receiving magnesium sulfate
- High risk pregnancies (Preeclampsia/eclampsia, cholestasis, intrauterine growth retardation, fetal anomaly, polyhydramnios or oligohydramnios)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peanut Ball Use on Labor Process and Maternal - Neonatal Outcomes in Obese Pregnants
The purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women.
Read the detailed description
After being informed about the study, all participants giving written informed consent, on the active phase of labor (cervical dilatation = 5 cm), the pregnant women in the experimental group will be provided with a position change lasting at least 30 minutes every hour with a peanut ball. The peanut ball will be used with a sheath that is changed for each participant. Pregnant women in the control group will be included in the study during the active phase of labor (cervical dilatation = 5 cm). No intervention will be made by the researcher. They will receive standard care by the service nurse.
- Conditions
- Labor Long
- Being tested
- position with peanut ball
- Keywords
- Peanut ball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
position with peanut ballOther
The experimental group will be positioned with the peanut ball until the end of the active phase of labor.
| Study group | Role | What they receive |
|---|---|---|
| Peanut ball intervention | Experimental | The experimental group. In the active phase of the labor (cervical dilatation = 5 cm), the peanut ball, which has a cover provided by the researcher and changed in each patient, will be placed between the knees of the participant for at least 30 minutes every hour, and a position change will be provided with the peanut ball in each time. The positions to be given with the peanut ball, semi sitting lunge, side lying, tucked, leaning forward, pushing and sitting position. Receives: Other: position with peanut ball |
| Control group | No intervention | Standard care will be given to the control group without positioning with a peanut ball. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor time
The primary outcome measure is the length of first stage (active phase) and second stage of labor in obese pregnant women.
Measured: From 5 cm of cervical dilatation to the second stage of labor
Secondary outcomes (6)
Pain level
Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 10 cm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain (0: no pain 10: severe pain)
Measured: Latent phase, active phase and at cervical dilatation 10 cm (on contractions)
Operative vaginal delivery rate
Forceps/vacuum
Measured: From 5 cm of cervical dilatation to the expulsion phase of labor
Type of delivery
Cesarean section or vaginal delivery
Measured: From 5 cm of cervical dilatation to the expulsion phase of labor
Maternal complications
Perineal laceration and atony
Measured: From 5 cm of cervical dilatation to the expulsion phase of labor
Neonatal complications
APGAR score, need for neonatal intensive care. For the Apgar score, five symptoms are checked, including respiration, heart rate, color, tone, and response to stimuli. Each symptom is scored as 0, 1, or 2. The baby is scored as '0' if there is no breathing or heartbeat, his color is pale or cyanotic, his tone is loose, and he does not respond to the stimulus given by inserting the catheter into the nose.
Measured: From 5 cm of cervical dilatation to the expulsion phase of labor
Birth satisfaction
Birth Satisfaction Scale A minimum of 30 and a maximum of 150 points are obtained from the scale. The higher the score, the higher the level of satisfaction.
Measured: Postpartum first hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start21 Mar 2022
- Primary completion13 Aug 2023
- Study completion13 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor LongStudies 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
- Model description
- There will be an intervention group and a control group.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fulden Ozkececi, Gulhane Training and Research Hospital
- Investigators
- Gulten GUVENC, PhD, RN, Study director, Gulhane Faculty of Nursing, University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276947
- Sponsor's protocol ID
- PBinON
- Status last verified
- Sep 2023
- First submitted
- 7 Feb 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozkececi F, Guvenc G. The Effect of Peanut Ball Use on the Labour Process and Maternal-Neonatal Outcomes in Parturient Women With High Maternal Body Mass Index: A Randomized Controlled Trial. Int J Nurs Pract. 2026 Apr;32(2):e70144. doi: 10.1111/ijn.70144.
PubMed 42026814
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peanut Ball Use on Labor Process and Maternal - Neonatal Outcomes in Obese Pregnants
- ClinicalTrials.gov ID
- NCT05276947
- Acronym / sponsor ID
- PBinON
- Conditions
- Labor Long
- Keywords
- Peanut ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 13 Aug 2023 (actual)
- Study completion
- 13 Aug 2023 (actual)
- First posted
- 14 Mar 2022 (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.
The purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women.
Detailed description
After being informed about the study, all participants giving written informed consent, on the active phase of labor (cervical dilatation = 5 cm), the pregnant women in the experimental group will be provided with a position change lasting at least 30 minutes every hour with a peanut ball. The peanut ball will be used with a sheath that is changed for each participant. Pregnant women in the control group will be included in the study during the active phase of labor (cervical dilatation = 5 cm). No intervention will be made by the researcher. They will receive standard care by the service nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be an intervention group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Peanut ball intervention | Experimental | Other: position with peanut ballThe experimental group. In the active phase of the labor (cervical dilatation = 5 cm), the peanut ball, which has a cover provided by the researcher and changed in each patient, will be placed between the knees of the participant for at least 30 minutes every hour, and a position change will be provided with the peanut ball in each time. The positions to be given with the peanut ball, semi sitting lunge, side lying, tucked, leaning forward, pushing and sitting position. |
| Control group | No intervention | –Standard care will be given to the control group without positioning with a peanut ball. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Admitted for delivery
- Maternal BMI > 30kg/m2 at admission
- Gestational age > 37 weeks 0 days
- Singleton pregnancy
- Cephalic presentation
Key exclusion criteria (7 listed)
- Pre-pregnancy BMI < 30kg/m2
- Gestational age < 37 weeks 0 days
- Multifetal gestation
- Intrauterine fetal demise
- Musculoskeletal problems
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 |
|---|---|---|
| position with peanut ballThe experimental group will be positioned with the peanut ball until the end of the active phase of labor. | Other | Peanut ball intervention |
Primary outcome
Labor time
Time frame: From 5 cm of cervical dilatation to the second stage of labor
The primary outcome measure is the length of first stage (active phase) and second stage of labor in obese pregnant women.
6 secondary outcomes
Pain level
Time frame: Latent phase, active phase and at cervical dilatation 10 cm (on contractions)
Operative vaginal delivery rate
Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor
Type of delivery
Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor
Maternal complications
Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor
Neonatal complications
Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor
Birth satisfaction
Time frame: Postpartum first hour
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 13 Sep 2023.
- Derived from this study: PubMed 42026814Ozkececi F, Guvenc G. The Effect of Peanut Ball Use on the Labour Process and Maternal-Neonatal Outcomes in Parturient Women With High Maternal Body Mass Index: A Randomized Controlled Trial. Int J Nurs Pract. 2026 Apr;32(2):e70144. doi: 10.1111/ijn.70144.
- Individual participant dataSharing planned: No
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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.
Gulten GUVENC, PhD, RN study director
Gulhane Faculty of Nursing, University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing position with peanut ball in people with Labor Long, run by Gulhane Training and Research Hospital 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 7 inclusion and 7 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 13 Sep 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?
Labor time (time frame: From 5 cm of cervical dilatation to the second stage of labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276947, which also lists 1 linked publication.
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 13 Sep 2023.