The Use of Peanut Ball in Labor in Obese Women

Labor Long Clinical Trial

Official title:

The Effect of Peanut Ball Use on Labor Process and Maternal - Neonatal Outcomes in Obese Pregnants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276947
• Other study ID #: PBinON
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: August 13, 2023

Study information

• Verified date: September 2023
• Source: Gulhane Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 13, 2023
• Est. primary completion date: August 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Labor Long

Intervention

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

Locations

Country	Name	City	State
Turkey	Gulhane Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Operative vaginal delivery rate	Forceps/vacuum	From 5 cm of cervical dilatation to the expulsion phase of labor
Secondary	Type of delivery	Cesarean section or vaginal delivery	From 5 cm of cervical dilatation to the expulsion phase of labor
Secondary	Maternal complications	Perineal laceration and atony	From 5 cm of cervical dilatation to the expulsion phase of labor
Secondary	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
Secondary	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