NCT05708482

Brief Summary

It is an experimental and randomized controlled study planned to evaluate the effect of sling-swinging position on the birth experience in vaginal delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

January 23, 2023

Last Update Submit

December 18, 2023

Conditions

Keywords

delivery duration

Outcome Measures

Primary Outcomes (2)

  • Duration of Labor

    It is about time as a minute

    during labor process

  • Satisfaction of Labor

    It is about a point which is evaluated by using form. This simple form was developed by researchers. It has five state and its maximum point is 25 and minimum point is 5. The satisfaction increases, the point increases.

    postpartum second hour

Study Arms (2)

Sling-Swing Group

EXPERIMENTAL

1. While the pregnant woman has 6 cm cervical dilatation examination, the flexible fabric will pass under the arms of the pregnant woman to form a hanger shape. The pregnant woman will be asked to hold the fabric on her feet in a squat and the hanging technique will be applied for 10 minutes. Then, a swing shape will be created in such a way that the flexible fabric will wrap around the chest area of the pregnant woman. The pregnant woman will be asked to hold the fabric in a squat above the knee and the rocking technique will be applied for 10 minutes. Subsequently, uterine contractions, fetal heart rate, fetal head level, position and presence of molding will be evaluated. 2. Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), this applicant will be experienced by them as the same procedure, hourly. 3. A Birth Satisfaction Form will be filled at the 2nd hour after delivery..

Other: Sling-Swing Position

Standard Care Group

NO INTERVENTION

1. While the pregnant woman has 6 cm cervical dilatation examination, uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated. 2. Until the completion of the first stage of labor (10 cm cervical dilatation, 100% cervical effacement), uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated every hour. 3. A Birth Satisfaction Form will be filled at the 2nd hour after delivery. At the end of the study, delivery times and satisfaction of pregnant women will be analyzed.

Interventions

The device is hammock which look likes a rope

Sling-Swing Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • According to Robson scoring, the midwife can follow the birth process.
  • Pregnant women who are in the active phase of the first stage of labor

You may not qualify if:

  • It was decided to deliver by cesarean section due to any indication.
  • Pharmacological approach applied
  • Any maternal-fetal complication developed
  • Those with a height of 150 cm and below
  • Pregnant women who want to quit working
  • Does not know Turkish language (reading-writing-speaking-listening)
  • Pregnant women diagnosed with mental and/or auditory disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital- Maternity Hospital

Ankara, Çankaya, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 1, 2023

Study Start

September 30, 2022

Primary Completion

May 30, 2023

Study Completion

September 30, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

It is about the ethical process.

Locations