Labor DurationNCT07053371
Peanut Ball During the First Stage of Labor
A study testing Peanut birth ball in people with Labor Duration, run by Mansoura University.
Trial summary
The current study aimed to assess the effectiveness of peanut ball during first stage of labor on maternal and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Duration
- What is being tested?
- Peanut birth ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low-risk primipara in active phase of labor, aged 20 -35 years with single living fetus in cephalic presentation and full-term pregnancy which lasts between 37-42 weeks
Who cannot join
- Women with medical or obstetric complications were excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Peanut Ball During the First Stage of Labor on Maternal and Neonatal Outcomes
The current study aimed to assess the effectiveness of peanut ball during first stage of labor on maternal and neonatal outcomes.
Read the detailed description
Labor, the climax of pregnancy, involves specialized care that covers women's social, physiological, anatomical, and emotional demands. Comfort must always come first throughout labor, and supportive techniques are essential from the prodromal to the expulsive phases.
The painful uterine contractions that precede the entire cervical dilatation characterize the 1st stage of labor. The 1st stage of labor consists of three stages: the latent phase, the active phase, and the transition period. The uterine tissues' distension and the cervix's dilatation are the causes of the cramp-like contraction discomfort at this stage, which is transmitted to the abdomen and lumbosacral regions by spinal nerves.
Stress brought on by labor pain might result in an excess of stress chemicals like catecholamines and steroids. This hormone can increase blood vessel vasoconstriction and smooth muscle tension, which can halt uterine contractions, lower uteroplacental circulation, and reduce the uterus's blood supply and oxygen, all of which exacerbate pain perceptions. The blood concentration of catecholamines rises with prolonged delivery.
The appropriate management of labor pain continues to be one of the most important aspects of intrapartum care. Therefore, enhancing the comfort of mothers giving birth is one of the most important responsibilities of nurses and other healthcare professionals. Women might feel comfort and control during childbirth if health issues are less common. Many efforts have been made to improve the outcomes of mother and newborn births and to reduce the duration of labor.
Changes in posture and freedom of mobility are useful strategies to lessen the impact of labor pain. During the prenatal period, posture changes and techniques to control labor pain should be taught. Pregnant women who were not educated throughout the prenatal period should be informed about the importance of movement and position changes during the latent phase of labor and when pain is at its lowest and communication is at its highest.
Numerous physiological measures were implemented to shorten the length of labor including pelvic rocking, deep breathing exercises, pregnancy exercises, and birthing ball exercises. Frequent position adjustments and movements during labor are recommended by the World Health Organization (WHO) as a way to reduce prolonged labor and avoid cesarean sections. To address these issues and put WHO recommendations into practice, the peanut birth ball could be a useful tool for routine position modifications without interfering with labor procedures.
Peanut balls are presented as a new strategy for improving women's labor and delivery outcomes. Although women have used birthing balls to advance labor for many years, the peanut ball is available in different sizes to make sure that women will find it comfortable. Furthermore, for women who have had an epidural, the peanut ball may be utilized in four different postures depending on the fetal station and stage of labor. Furthermore, it has the advantages of being affordable, reusable, and noninvasive.
Because the elasticity of the ball stimulates endorphin receptors in the pelvis, sitting and swinging on it makes the woman feel more at ease and encourages the release of endorphins. Additionally, the expansion and relaxation of pelvic muscles and bones, as well as the process of delivery, are aided by gravity, which improves fetal descent.
Maternity nurses play a crucial role in ensuring safe and normal childbirth. They need to closely monitor the progress of labor to facilitate a smooth delivery. Furthermore, satisfying the woman's emotional requirements following her physical demands will enable a happy delivery experience and contribute to the safe commencement of mother-infant bonding..
- Conditions
- Labor Duration
- Being tested
- Peanut birth ball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut birth ballOther
The 45 x 80 cm peanut birth ball was positioned between the woman's legs during the first stage's active phase, starting at 4 cm cervical dilatation for the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Women in this group to utilize peanut birth balls Receives: Other: Peanut birth ball |
| Control group | No intervention | The control group received conventional hospital care from their obstetrician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress of labor, duration of each stage
Analysis of the progress of labor and the duration of labor stages
Measured: During the active phase of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor DurationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053371
- Sponsor's protocol ID
- Peanut Ball during labor Stage
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hickey L, Savage J. Effect of Peanut Ball and Position Changes in Women Laboring With an Epidural. Nurs Womens Health. 2019 Jun;23(3):245-252. doi: 10.1016/j.nwh.2019.04.004. Epub 2019 May 9.
PubMed 31077640Mercier RJ, Kwan M. Impact of Peanut Ball Device on the Duration of Active Labor: A Randomized Control Trial. Am J Perinatol. 2018 Aug;35(10):1006-1011. doi: 10.1055/s-0038-1636531. Epub 2018 Mar 6.
PubMed 29510425
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peanut Ball During the First Stage of Labor on Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT07053371
- Acronym / sponsor ID
- Peanut Ball during labor Stage
- Conditions
- Labor Duration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 8 Jul 2025 (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 current study aimed to assess the effectiveness of peanut ball during first stage of labor on maternal and neonatal outcomes.
Detailed description
Labor, the climax of pregnancy, involves specialized care that covers women's social, physiological, anatomical, and emotional demands. Comfort must always come first throughout labor, and supportive techniques are essential from the prodromal to the expulsive phases.
The painful uterine contractions that precede the entire cervical dilatation characterize the 1st stage of labor. The 1st stage of labor consists of three stages: the latent phase, the active phase, and the transition period. The uterine tissues' distension and the cervix's dilatation are the causes of the cramp-like contraction discomfort at this stage, which is transmitted to the abdomen and lumbosacral regions by spinal nerves.
Stress brought on by labor pain might result in an excess of stress chemicals like catecholamines and steroids. This hormone can increase blood vessel vasoconstriction and smooth muscle tension, which can halt uterine contractions, lower uteroplacental circulation, and reduce the uterus's blood supply and oxygen, all of which exacerbate pain perceptions. The blood concentration of catecholamines rises with prolonged delivery.
The appropriate management of labor pain continues to be one of the most important aspects of intrapartum care. Therefore, enhancing the comfort of mothers giving birth is one of the most important responsibilities of nurses and other healthcare professionals. Women might feel comfort and control during childbirth if health issues are less common. Many efforts have been made to improve the outcomes of mother and newborn births and to reduce the duration of labor.
Changes in posture and freedom of mobility are useful strategies to lessen the impact of labor pain. During the prenatal period, posture changes and techniques to control labor pain should be taught. Pregnant women who were not educated throughout the prenatal period should be informed about the importance of movement and position changes during the latent phase of labor and when pain is at its lowest and communication is at its highest.
Numerous physiological measures were implemented to shorten the length of labor including pelvic rocking, deep breathing exercises, pregnancy exercises, and birthing ball exercises. Frequent position adjustments and movements during labor are recommended by the World Health Organization (WHO) as a way to reduce prolonged labor and avoid cesarean sections. To address these issues and put WHO recommendations into practice, the peanut birth ball could be a useful tool for routine position modifications without interfering with labor procedures.
Peanut balls are presented as a new strategy for improving women's labor and delivery outcomes. Although women have used birthing balls to advance labor for many years, the peanut ball is available in different sizes to make sure that women will find it comfortable. Furthermore, for women who have had an epidural, the peanut ball may be utilized in four different postures depending on the fetal station and stage of labor. Furthermore, it has the advantages of being affordable, reusable, and noninvasive.
Because the elasticity of the ball stimulates endorphin receptors in the pelvis, sitting and swinging on it makes the woman feel more at ease and encourages the release of endorphins. Additionally, the expansion and relaxation of pelvic muscles and bones, as well as the process of delivery, are aided by gravity, which improves fetal descent.
Maternity nurses play a crucial role in ensuring safe and normal childbirth. They need to closely monitor the progress of labor to facilitate a smooth delivery. Furthermore, satisfying the woman's emotional requirements following her physical demands will enable a happy delivery experience and contribute to the safe commencement of mother-infant bonding..
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Peanut birth ballWomen in this group to utilize peanut birth balls |
| Control group | No intervention | –The control group received conventional hospital care from their obstetrician. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Low-risk primipara in active phase of labor, aged 20 -35 years with single living fetus in cephalic presentation and full-term pregnancy which lasts between 37-42 weeks
Key exclusion criteria (1 listed)
- Women with medical or obstetric complications were excluded from the study.
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 |
|---|---|---|
| Peanut birth ballThe 45 x 80 cm peanut birth ball was positioned between the woman's legs during the first stage's active phase, starting at 4 cm cervical dilatation for the intervention group | Other | Intervention group |
Primary outcome
Progress of labor, duration of each stage
Time frame: During the active phase of labor
Analysis of the progress of labor and the duration of labor stages
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Results publication: PubMed 31077640Hickey L, Savage J. Effect of Peanut Ball and Position Changes in Women Laboring With an Epidural. Nurs Womens Health. 2019 Jun;23(3):245-252. doi: 10.1016/j.nwh.2019.04.004. Epub 2019 May 9.
- Results publication: PubMed 29510425Mercier RJ, Kwan M. Impact of Peanut Ball Device on the Duration of Active Labor: A Randomized Control Trial. Am J Perinatol. 2018 Aug;35(10):1006-1011. doi: 10.1055/s-0038-1636531. Epub 2018 Mar 6.
- Related InfoLink provided by the sponsor.
Related trials for Labor Duration
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
Predicting Declines in Attention and Memory During a Prolonged Mental Task
Mental Fatigue, Cognitive Performance
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.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut birth ball in people with Labor Duration, run by Mansoura University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enas Sabry Fathy Elbeltagy, Dr. (01067364685, enassabry25@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress of labor, duration of each stage (time frame: During the active phase 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 NCT07053371, which also lists 2 linked publications.
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 8 Jul 2025.