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

  • STATUS
    Recruiting
  • End date
    Mar 9, 2023
  • participants needed
    598
  • sponsor
    Northwell Health
Updated on 4 October 2022
Accepts healthy volunteers

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

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.

Details
Condition Laboring Women
Treatment Peanut Ball positioning device
Clinical Study IdentifierNCT04998149
SponsorNorthwell Health
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women between 18 -50 years of age presenting in labor or for induction of
labor
Nulliparous (first delivery)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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