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Completed

NCT Number: NCT05276947

The Use of Peanut Ball in Labor in Obese Women

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.

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Key information

Conditions

Labor Long

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

position with peanut ball

Other

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

Primary outcomes

  1. Labor time

    Time frame: From 5 cm of cervical dilatation to the second stage of labor

    The primary outcome measure is the length of first stage (active phase) and second stage of labor in obese pregnant women.

Secondary outcomes

  1. Pain level

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

    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)

  2. Operative vaginal delivery rate

    Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor

    Forceps/vacuum

  3. Type of delivery

    Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor

    Cesarean section or vaginal delivery

  4. Maternal complications

    Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor

    Perineal laceration and atony

  5. Neonatal complications

    Time frame: From 5 cm of cervical dilatation to the expulsion phase of labor

    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.

  6. Birth satisfaction

    Time frame: Postpartum first hour

    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.

Sponsors and collaborators

Lead sponsor

Gulhane Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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