Birthing Ball (Peanut Ball) Positions

NCT04729426 | Completed DMC

• 1 other identifier: AnkaraYBU sbe
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it was aimed to position by using peanut ball, which is a kind of birth ball, in the first stage of delivery in pregnant women who are planned to have vaginal delivery with cephalic admission, who is a primipara, who do not have a risky pregnancy and systemic disease; It will be done to determine the effect on the birth process.

Conditions

Labor Pain; Labor Long

Keywords

Peanut ball; Birthing ball; labor positions; labor process

Outcome Measures

Primary Outcomes (1)

• Labor time

  Firsth stage ( active phase and transition phase) time+ and second stage labor time=...minutes

  max 8 hour

Secondary Outcomes (6)

• cervical dilation

  max 8 hour

• cervical effacement

  max 8 hour

• fetal head level

  max 8 hour

• The pain level

  max 8 hour

• The first breastfeeding process evaluation

  within 30 minutes after labor

Study Arms (2)

Position Group

EXPERIMENTAL

Position group

Other: Peanut Ball Position

Control group

NO INTERVENTION

No Position group

Interventions

Peanut Ball Position OTHER

The group of healthy pregnant women who meet the inclusion criteria will be determined by randomization according to the order of application to the delivery room. A group (intervention group) will be given positions using the peanut ball tool in active phase and transition phase and the positions will be changed every 30 minutes.

Position Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: primipara pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous at 37-42 weeks of gestation,
• between the ages of 18-40,
• Not diagnosed with risky pregnancy (Intrauterine Growth Retardation, Fetal Anomaly, Polyhydramnios or Oligohydraamnios, Thromboembolic Diseases, Presentation Anomalies, Premature Membrane Rupture, Multiple Pregnancy, Sexually Transmitted Disease, Preeclampsia / Eclampsia etc.)
• Without systemic disease (Hypertension, Heart Disease, Diabetes, Asthma, Thyroid, Epilepsy, etc.)
• Single pregnancy,
• Vaginal delivery planned with cephalic admission,
• in the latent phase of labor,
• Epidural anesthesia / analgesia was not applied,
• Volunteering to participate in research,
• Pregnant women who do not have any communication disorder will be taken.

You may not qualify if:

• Having adaptation problems in applying the positions to be given,
• Maternal (vital signs deviation from normal, hyperstimulation, abnormal bleeding, etc.) and fetal complications (such as fetal distress, cord entanglement, cord prolapse) during delivery,
• Caesarean section, which could not complete the normal birth process,
• Pregnant women who give up working at any stage of the study will be excluded from the study.

Sponsors & Collaborators

• Gonca Karataş Baran: lead

Study Sites (1)

Ankara Şehir Hastanesi Kadın Doğum Hastanesi

Ankara, Bilkent, Turkey (Türkiye)

Location

Related Publications (3)

• Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing Length of Labor and Cesarean Surgery Rate Using a Peanut Ball for Women Laboring With an Epidural. J Perinat Educ. 2015;24(1):16-24. doi: 10.1891/1058-1243.24.1.16.

  PMID: 26937158 RESULT

• Roth C, Dent SA, Parfitt SE, Hering SL, Bay RC. Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):140-6. doi: 10.1097/NMC.0000000000000232.

  PMID: 26859467 RESULT

• Grenvik JM, Rosenthal E, Saccone G, Della Corte L, Quist-Nelson J, Gerkin RD, Gimovsky AC, Kwan M, Mercier R, Berghella V. Peanut ball for decreasing length of labor: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:159-165. doi: 10.1016/j.ejogrb.2019.09.018. Epub 2019 Sep 20.

  PMID: 31600716 RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esma SARIKAYA, professor

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The volunteer who is in the latent phase of labor will not know which group she will be in before joining the study. After accepting to participate in the study, the volunteer will be informed about which group she will be in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ankara Yildirim Beyazıt University Student

Model Details: There will be two group. One is interventional group; other is control group.

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 28, 2021
• Study Start: February 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)