The Effect of the Use of Peanut Ball on Labor Time in Nulliparous Women

NCT ID: NCT04998149

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2024-05-30

Brief Summary

Peanut ball use has become popular with midwives and nurses because it is an inexpensive, nonpharmacological intervention that can help with positioning the patient to decrease labor time. The peanut ball allows the patient to reposition her legs in a way that mimics squatting and changes the diameter of the pelvis. This can aid in cervical dilatation and the descent of the fetus. In turn, laboring down can decrease the time spent pushing and prevent maternal exhaustion.

This study aims to test the following hypotheses:

The use of the peanut ball compared to standard of care will:

1. Reduce the time (in minutes) between administration of epidural and complete cervical dilation

2. Reduce pushing time as measured by duration of time pushing to the delivery of the baby

3. Decrease the rate of cesarean sections in nulliparous women

Detailed Description

This is a randomized control study. Each patient who meets the inclusion criteria will be informed about the study within 12 hours of admission to the unit. When the participant is alert and prior to administration of medicinal pain relief measures, the patient will be asked to consent to be a participant. Basic admission demographic information will be collected from the electronic medical record (EMR) and will be used to identify potential subjects (inclusion/exclusion criteria). Recruitment will include a scripted informative conversation with the potential subject along with an informed consent to further determine eligibility and willingness to participate in the study.

The peanut ball size will be determined by the patient weight indicated on the peanut ball itself and compared with the patient's documented weight in the EMR. The ball will be inflated prior to use and a pictorial introduction of how to use the peanut ball will be shown to the study subject.

The peanut ball use will be discontinued immediately prior to the delivery of the baby. The study time will be documented and calculated for all subjects (treatment and control) from the time of introduction of epidural analgesia to the delivery of the baby.

The proposed Peanut Ball manufactured by Clinton industries at graylinemedical.com is made from durable, ribbed, heavy-walled, polyvinyl chloride (PVC) material, burst resistant, deflate slowly if punctured, and latex free with non-slip grip ridges. It is available in variable sizes ranging from 40 cm-70 cm in length. It is re-usable, after cleaning with hospital grade wipes. It is recommended that the peanut balls should be protected from sunlight and sharp objects.

Conditions

Laboring Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

standard care

The control group subjects will receive standard of care during labor using pillows and wedges as positional devices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Peanut ball intervention

The experimental group will receive peanut ball as positioning device during labor

Group Type: EXPERIMENTAL

Peanut Ball positioning device

Intervention Type: DEVICE

Peanut Ball manufactured by Clinton industries at graylinemedical.com https://www.graylinemedical.com/products/clinton-industries-peanut-ball-peanut-ball-40-cm-yellow-8540?\_pos=3\&\_sid=d6e52e63c\&\_ss=r

Interventions

Peanut Ball positioning device

Peanut Ball manufactured by Clinton industries at graylinemedical.com https://www.graylinemedical.com/products/clinton-industries-peanut-ball-peanut-ball-40-cm-yellow-8540?\_pos=3\&\_sid=d6e52e63c\&\_ss=r

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Women between 18 -50 years of age presenting in labor or for induction of labor

• Nulliparous (first delivery)
• 37 0/7- 41 6/7 weeks of gestation
• Singleton, Vertex presentation
• Plan to deliver with epidural anesthesia
• Has had at least one vaginal exam to determine the cervical dilatation prior to the proposed intervention
• Prescribed Oxytocin (Pitocin)

Exclusion Criteria

• Multi gravida women
• Admitted in second stage of labor
• Multiple gestations
• Non-vertex presentations
• Women receiving magnesium sulfate
• Preterm or post term labor (<37 weeks or >42 weeks)
• Women with hypertensive disorders of pregnancy
• Diabetes including gestational diabetes
• Muscular or skeletal limitations that does not allow for positioning
• Un-medicated labors ( delivery without epidural, about 5-20% )
• Category III fetal heart rate tracings
• Suspected infections (e.g. STDs, viral/bacterial infections)
• Planned cesarean delivery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Ani Jacob

Nurse Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huntington Hospital

Huntington, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Northwell health, Northern Westchester Hospital

Mount Kisco, New York, United States

Northwell Health, Peconic Bay Medical Center

Riverhead, New York, United States

Countries

United States

References

Delgado A, Maia T, Melo RS, Lemos A. Birth ball use for women in labor: A systematic review and meta-analysis. Complement Ther Clin Pract. 2019 May;35:92-101. doi: 10.1016/j.ctcp.2019.01.015. Epub 2019 Feb 2.

Reference Type: BACKGROUND

PMID: 31003693 (View on PubMed)

Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing Length of Labor and Cesarean Surgery Rate Using a Peanut Ball for Women Laboring With an Epidural. J Perinat Educ. 2015;24(1):16-24. doi: 10.1891/1058-1243.24.1.16.

Reference Type: BACKGROUND

PMID: 26937158 (View on PubMed)

Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):E9-E10. doi: 10.1097/NMC.0000000000000240. No abstract available.

Reference Type: BACKGROUND

PMID: 27128653 (View on PubMed)

Other Identifiers

21-0330

Identifier Type: -

Identifier Source: org_study_id