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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05708482
Other study ID # AnkaraCHBilkent-MH-NK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2022
Est. completion date September 30, 2023

Study information

Verified date December 2023
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In the sample calculation of the study, the sufficient sample size to be studied with a power of 95% based on d=0.8 (large) effect size alpha=0.05 was calculated using the G*Power 3.1.9.4 program, 35 for the application group and 35 for the control group, a total of 70 people. According to Robson scoring, the midwife can follow the birth process and Pregnant women who are in the active phase of the first stage of labor (5 cm cervical dilatation) are inclusion criterias. In the study, data have been collected using Introductory Information and Birth Process Follow-up Form and Postpartum Satisfaction Form were developed by the researchers. For intervention group: 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. The comfort of the pregnant woman will be questioned throughout the procedure. 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), the pregnant will be held in the hanging position for 10 minutes and rocking position for 10 minutes, once an hour. Uterine contractions, fetal heartbeat, fetal head level, position and presence of molding will be evaluated after each application, hourly. For control group: 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. For Each Group: 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date September 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Excluding the inclusion criteria - Does not know Turkish language (reading-writing-speaking-listening) - Pregnant women diagnosed with mental and/or auditory disabilities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sling-Swing Position
The device is hammock which look likes a rope

Locations

Country Name City State
Turkey Ankara City Hospital- Maternity Hospital Ankara Çankaya

Sponsors (2)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of Labor It is about time as a minute during labor process
Primary 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
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