The Use of Peanut Ball in Labor in Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Labor Long
• Intervention / Treatment: Other: position with peanut ball

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gulhane Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peanut ball intervention; 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.	Other: position with peanut ball; The experimental group will be positioned with the peanut ball until the end of the active phase of labor.
No Intervention: Control group; Standard care will be given to the control group without positioning with a peanut ball.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor time	The primary outcome measure is the length of first stage (active phase) and second stage of labor in obese pregnant women.	From 5 cm of cervical dilatation to the second stage of labor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Latent phase, active phase and at cervical dilatation 10 cm (on contractions)
Operative vaginal delivery rate	Forceps/vacuum	From 5 cm of cervical dilatation to the expulsion phase of labor
Type of delivery	Cesarean section or vaginal delivery	From 5 cm of cervical dilatation to the expulsion phase of labor
Maternal complications	Perineal laceration and atony	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.	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.	Postpartum first hour

Collaborators and Investigators

• Sponsor: Gulhane Training and Research Hospital
• Investigators: Study Director: Gulten GUVENC, PhD, RN, Gülhane Faculty of Nursing, University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): August 13, 2023
• Study Completion (Actual): August 13, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Peanut ball
• Other Study ID Numbers: PBinON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No