The Use of Peanut Ball in Labor in Obese Women

NCT05276947 | Completed

• 1 other identifier: PBinON
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Long

Keywords

Peanut ball

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain level

  Latent phase, active phase and at cervical dilatation 10 cm (on contractions)

• Operative vaginal delivery rate

  From 5 cm of cervical dilatation to the expulsion phase of labor

• Type of delivery

  From 5 cm of cervical dilatation to the expulsion phase of labor

• Maternal complications

  From 5 cm of cervical dilatation to the expulsion phase of labor

• Neonatal complications

  From 5 cm of cervical dilatation to the expulsion phase of labor

Study Arms (2)

Peanut ball intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

Standard care will be given to the control group without positioning with a peanut ball.

Interventions

position with peanut ball OTHER

The experimental group will be positioned with the peanut ball until the end of the active phase of labor.

Peanut ball intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gulten GUVENC, PhD, RN

  Gulhane Faculty of Nursing, University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be an intervention group and a control group.

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 14, 2022
• Study Start: March 21, 2022
• Primary Completion: August 13, 2023
• Study Completion: August 13, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)