NCT07053371

Brief Summary

The current study aimed to assess the effectiveness of peanut ball during first stage of labor on maternal and neonatal outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

June 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 27, 2025

Last Update Submit

June 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Progress of labor, duration of each stage

    Analysis of the progress of labor and the duration of labor stages

    During the active phase of labor

Study Arms (2)

Intervention group

EXPERIMENTAL

Women in this group to utilize peanut birth balls

Other: Peanut birth ball

Control group

NO INTERVENTION

The control group received conventional hospital care from their obstetrician.

Interventions

The 45 x 80 cm peanut birth ball was positioned between the woman's legs during the first stage's active phase, starting at 4 cm cervical dilatation for the intervention group

Intervention group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParturient women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Low-risk primipara in active phase of labor, aged 20 -35 years with single living fetus in cephalic presentation and full-term pregnancy which lasts between 37-42 weeks

You may not qualify if:

  • Women with medical or obstetric complications were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Hickey L, Savage J. Effect of Peanut Ball and Position Changes in Women Laboring With an Epidural. Nurs Womens Health. 2019 Jun;23(3):245-252. doi: 10.1016/j.nwh.2019.04.004. Epub 2019 May 9.

    PMID: 31077640BACKGROUND
  • Mercier RJ, Kwan M. Impact of Peanut Ball Device on the Duration of Active Labor: A Randomized Control Trial. Am J Perinatol. 2018 Aug;35(10):1006-1011. doi: 10.1055/s-0038-1636531. Epub 2018 Mar 6.

    PMID: 29510425BACKGROUND

Related Links

Central Study Contacts

Enas Sabry Fathy Elbeltagy, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

July 8, 2025

Record last verified: 2025-06