Clinical trial NCT04998149: The Effect of the Use of Peanut Ball on Labor Time in Nulliparous Women
Official title: The Effect of the Use of a Peanut Ball on Labor Time and "Pushing" After Epidural Anesthesia in Nulliparous Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laboring Women
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be a standard group and an intervention group selected by BRMS.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Decrease labor time
timeFrame: From epidural analgesia to delivery of the baby
Secondary outcomes:
measure: Decrease cesarean section deliveries
timeFrame: From epidural analgesia to delivery of the baby
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mount Kisco
country: United States
facility: Northwell health, Northern Westchester Hospital
state: New York
city: Riverhead
country: United States
facility: Northwell Health, Peconic Bay Medical Center
state: New York
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.