NCT06312449

Brief Summary

This study aims to explore the use of peanut balls during the second stage of labor. It compares three different positions: traditional lithotomy position, lateral position, and lateral position with peanut ball in terms of women's perceived pushing effort experiences, fatigue, and birth outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

February 27, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

Peanut ballSecond stage of laborPerceived effort experienceFatigue

Outcome Measures

Primary Outcomes (4)

  • The duration of the second stage of labor of women who use side-lying with peanut balls.

    The duration of the second stage of labor

    calculated from the labor records within 24 hours postpartum, will be recorded by the researcher onto the individual basic information form.

  • The pushing time of women in the second stage of labor who use side-lying with peanut balls.

    The second stage of labor pushing time

    As documented in the nursing records within 24 hours postpartum, will be transcribed by the researcher onto the second stage labor pushing record form.

  • lateral position with peanut ball in terms of women's perceived pushing effort experiences.

    Measuring pushing effort experiences

    Measurements will be conducted within 1 to 4 hours postpartum.

  • Parturients using the side-lying position with a peanut ball for experience levels of fatigue.

    Measuring fatigue

    Measurements will be conducted within 1 to 4 hours postpartum.

Study Arms (3)

The experimental group

EXPERIMENTAL

The second stage of delivery involves using the lateral position with peanut ball

Other: The side-lying position with the peanut ball during the second stage of labor.

Control Group A

PLACEBO COMPARATOR

The second stage of delivery adopts the lateral position

Other: During the second stage, the patient is placed in a lateral position

Control Group B

NO INTERVENTION

As usual care

Interventions

The usage of the peanut ball is divided into two stages: Stage one: The parturient assumes a side-lying position with the bed elevated to a 30-degree angle. The peanut ball is placed between the legs, allowing for leg separation. The parturient can choose to lie on either the left or right side according to preference. Stage two: When the fetal presenting part reaches 1 centimeter below the ischial spine (+1 Station), still in a side-lying position with the bed elevated to a 30-degree angle, the parturient has the option to switch sides. The peanut ball is then positioned between the legs with the knees bent together, for pushing

The experimental group

The parturient assumes a side-lying position with the bed elevated to a 30-degree angle. The parturient can choose to lie on either the left or right side according to preference.When the fetal presenting part reaches 1 centimeter below the ischial spine (+1 Station), still in a side-lying position with the bed elevated to a 30-degree angle, the parturient has the option to switch sides, for pushing

Control Group A

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous women with a singleton fetus in cephalic presentation at 36 weeks gestation or later.
  • Anticipated vaginal delivery.
  • Ability to understand, speak, read, and write Chinese.
  • Normal prenatal examination findings for the fetus.
  • Low-risk pregnancy.
  • Voluntary participation after receiving an explanation of the study.

You may not qualify if:

  • Mothers or fetuses experiencing abnormalities during labor requiring emergency cesarean section.
  • Participants unwilling to engage in the side-lying position with exertion using the peanut ball during the second stage of labor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yu-Ching Tung

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Ching Tung, Nurse

    Chang Gung Medical Foundation Institutional Review Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Linkou Chang Gung Memorial Hospital, Delivery Room, Vice Head Nurse

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 15, 2024

Study Start

March 1, 2023

Primary Completion

September 20, 2023

Study Completion

September 23, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations