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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05863156
Other study ID # NST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 30, 2021
Est. completion date November 30, 2022

Study information

Verified date May 2023
Source Uskudar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to examine the effects of different positions given to pregnant women during electro fetal monitoring on maternal and fetal health. The study was conducted in a pregnant follow-up outpatient clinic of a maternity hospital in Istanbul, between December 2021 and January 2023, in a randomized controlled experimental study design with two interventions and a control group. In the study, 60 participants were placed in the right side lying position (intervention 1), 60 participants in the semi-sitting position (intervention 2) and 120 participants in the left side lying position (control group), and the study was completed with a total of 240 pregnant women. According to NST extraction positions, systolic blood pressure and body temperature of the pregnant women were found to have a statistically significant difference between pre-NST extraction, NST extraction time and post-NST extraction positions, time and group-time (p<0.05). It was determined that the difference between the groups was that the semi-sitting position created a significant difference compared to the other position averages. In terms of time, the NST moment made a difference compared to other times. It was determined that the right position made a statistical difference compared to the other position averages in the pulse count. It was found that the semi-sitting position had a statistically significant effect on maternal comfort (t=3.834, p<0.05). It was determined that the semi-sitting position caused an increase of 0.911 on general comfort (β=0.911).


Description:

Introduction: Electro Fetal Monitoring is widely used all over the world because it is non-invasive, accessible and easy to use in the follow-up of pregnancy and labor. The accuracy of the result is affected by factors such as the position of the pregnant woman during the procedure, maternal comfort and maternal blood pressure. Objective: The aim of this study was to examine the effects of different positions given to pregnant women during electro fetal monitoring on maternal and fetal health. Method: The study was conducted in a pregnant follow-up outpatient clinic of a maternity hospital in Istanbul, between December 2021 and January 2023, in a randomized controlled experimental study design with two interventions and a control group. In the study, 60 participants were placed in the right side lying position (intervention 1), 60 participants in the semi-sitting position (intervention 2) and 120 participants in the left side lying position (control group), and the study was completed with a total of 240 pregnant women. Research data were collected through the Information Form and the General Comfort Scale-Short Form.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date November 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Being over the age of 18, - Being 35 years of age and under, - Being a single fetus in the late 3rd trimester (34th-40th gestational week), - Fetal biometric measurements between 34-40 weeks of gestation, - No maternal and fetal risk affecting pregnancy, - It was determined that the vital signs were within normal values before the application, not being hungry during the application (at the latest 2 hours of fasting time will be checked), and accepting the recommended application position. Exclusion Criteria: - The pregnant woman does not accept the recommended application position.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Right side lying position
In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi Fowler
In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying position
In the study, 120 participants in the left side lying position (control group).

Locations

Country Name City State
Turkey Uskudar Univercity Istanbul Ümraniye

Sponsors (1)

Lead Sponsor Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Humphries A, Mirjalili SA, Tarr GP, Thompson JMD, Stone P. The effect of supine positioning on maternal hemodynamics during late pregnancy. J Matern Fetal Neonatal Med. 2019 Dec;32(23):3923-3930. doi: 10.1080/14767058.2018.1478958. Epub 2018 Jun 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other right side lying Blood Pressure (Systolic) post NST
Primary right side lying post NST (3) Blood Pressure (Systolic) before NST
Secondary right side lying Blood Pressure (Systolic) NST instant
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