NCT06538545

Brief Summary

This study was conducted to determine the effect of sitting position on the labor process. The randomized controlled experimental study was conducted in the delivery room of Sivas Numune Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

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

May 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

July 24, 2024

Last Update Submit

August 5, 2024

Conditions

Keywords

Bleedingpregnantlabor durationpainSitting Position

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale is applied starting from the 1st stage of labor and until the end of the 2nd stage.If the VAS value is 10, it means there is a lot of pain, and if it is 0, it means there is no pain.

    The effect of sitting positions of pregnant women in the 38-42nd weeks of pregnancy on the birth process

    1 years

Study Arms (4)

Arm 1:Vertical Position (Experimental Group-Primiparous)

EXPERIMENTAL

All pregnant women in the experimental group were allowed to use a sitting position (sitting and rocking on a pilates ball or sitting on a bed) from the active phase until labor. They were allowed to lie down for 10-15 minutes when they were tired or when monitoring or intervention was needed.

Behavioral: Sitting position is used in Experimental Arms 1-2

Arm 2: Vertical Position (Experimental Group-Multiparous)

EXPERIMENTAL

All pregnant women in the experimental group were allowed to use a sitting position (sitting and rocking on a pilates ball or sitting on a bed) from the active phase until labor. They were allowed to lie down for 10-15 minutes when they were tired or when monitoring or intervention was needed.

Behavioral: Sitting position is used in Experimental Arms 1-2

Arm 3: Lithotomy Position (Control Group-Primiparous)

ACTIVE COMPARATOR

All pregnant women in the control group were followed up with hospital procedures during labor. From the latent phase until labor, the pregnant woman was followed up with hospital procedures. At the end of the latent and active phases, pain assessment was requested and VAS (Appendix 6) was applied. The 2nd and 3rd stages of labor were performed on a normal delivery table in the lithotomy position.

Behavioral: Sitting position is used in Experimental Arms 1-2

Arm 4: Lithotomy Position (Control Group-multiparous)

ACTIVE COMPARATOR

The hospital procedure was applied to determine the birth rates of all pregnant women in the control group. From the latent stage until the birth, the pregnant woman is followed up by applying the hospital procedure. At the end of the latent and active phases, the alarm results were requested to be evaluated and VAS (Appendix 6) was developed. The 2nd and 3rd stages of labor were performed in the lithotomy positions on the normal delivery table.

Behavioral: Sitting position is used in Experimental Arms 1-2

Interventions

sitting position Comparison of sitting position and lithotomy position in labor

Also known as: Lithotomy position is used in those with Active Comparison Arm 3-4.
Arm 1:Vertical Position (Experimental Group-Primiparous)Arm 2: Vertical Position (Experimental Group-Multiparous)Arm 3: Lithotomy Position (Control Group-Primiparous)Arm 4: Lithotomy Position (Control Group-multiparous)

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range: 19-35
  • weeks of pregnancy
  • No health problems that would prevent the use of sitting position
  • Amniotic membranes not ruptured
  • Having a singleton pregnancy
  • Fetus in vertex position
  • Labor occurs with normal spontaneous vaginal delivery
  • No diagnosed chronic physical disease
  • No diagnosed psychiatric disease
  • No risky pregnancy, risky delivery and newborn/fetus
  • No communication problems
  • Voluntarily participating in the research

You may not qualify if:

  • Only women who gave birth at Sivas Sample Hospital were included in the study
  • Women who gave birth more than two times were not included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hilal Güveri

Sivas, Sivas Merkez, 58000, Turkey (Türkiye)

Location

Cumhuriyet Üniversitesi

Sivas, 58000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HemorrhagePain

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 5, 2024

Study Start

May 2, 2022

Primary Completion

November 2, 2022

Study Completion

April 4, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Yes: There is a plan to make IPD and related data dictionaries available.

Shared Documents
STUDY PROTOCOL
Time Frame
1 years

Locations