Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring

February 7, 2025 updated by: Tuğba YILMAZ ESENCAN, Uskudar University

Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring on Maternal Comfort, Maternal Blood Pressure and Fetal Health

The objective of this study was to assess the effects of different maternal positions during electronic fetal monitoring (EFM) on maternal and fetal health outcomes. The study was conducted between December 2021 and January 2023 in a maternity hospital in Istanbul, employing a randomized controlled trial design. A total of 240 pregnant women were randomized into three groups: 60 participants were assigned to the right-side lying position (intervention 1), 60 to the semi-sitting position (intervention 2), and 120 to the left-side lying.

Maternal systolic blood pressure, body temperature, and pulse rate were measured before, during, and after the EFM procedure. Research data were collected through the Information Form and the General Comfort Scale-Short Form.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

IIntroduction: Electronic fetal monitoring (EFM) is widely utilized for pregnancy and labor management due to its non-invasive nature, ease of use, and accessibility. However, the accuracy of EFM outcomes may be influenced by various factors, including the maternal position during monitoring, maternal comfort, and maternal blood pressure. This study aimed to explore how different positions during EFM influence both maternal.

Objective: The primary objective of this study was to examine the effects of three different maternal positions during EFM-right-side lying, semi-sitting, and left-side lying-on maternal and fetal health parameters. These parameters included systolic blood pressure, body temperature, pulse rate, and maternal comfort.

Methods:

A randomized controlled trial was conducted in a pregnancy follow-up outpatient clinic at a maternity hospital in Istanbul from December 2021 to January 2023. The study included 240 pregnant women, who were randomly assigned to one of three groups:

  • Intervention 1 (right-side lying position) - 60 participants
  • Intervention 2 (semi-sitting position) - 60 participants
  • Control group (left-side lying position) - 120 participants Maternal physiological data were collected at three time points: pre-EFM, during EFM, and post-EFM. The General Comfort Scale-Short Form was used to assess maternal comfort. Statistical analyses were conducted to identify significant differences between groups and over time.

Study Type

Interventional

Enrollment (Actual)

305

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ümraniye
      • İstanbul, Ümraniye, Turkey, 34000
        • Uskudar Univercity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention 1
electro fetal monitoring
Diagnostic test: Right side lying position
In the study, 60 participants were placed in the right side lying position (intervention 1)
Other Names:
  • (intervention 1)
Diagnostic test: Semi Fowler
In the study, 60 participants in the semi-sitting position (intervention 2)
Other Names:
  • (intervention 2)
Diagnostic test: left side lying position
In the study, 120 participants in the left side lying position (control group).
Other Names:
  • (control group)
Experimental: intervention 2
electro fetal monitoring
Diagnostic test: Right side lying position
In the study, 60 participants were placed in the right side lying position (intervention 1)
Other Names:
  • (intervention 1)
Diagnostic test: Semi Fowler
In the study, 60 participants in the semi-sitting position (intervention 2)
Other Names:
  • (intervention 2)
Diagnostic test: left side lying position
In the study, 120 participants in the left side lying position (control group).
Other Names:
  • (control group)
Experimental: control group
electro fetal monitoring
Diagnostic test: Right side lying position
In the study, 60 participants were placed in the right side lying position (intervention 1)
Other Names:
  • (intervention 1)
Diagnostic test: Semi Fowler
In the study, 60 participants in the semi-sitting position (intervention 2)
Other Names:
  • (intervention 2)
Diagnostic test: left side lying position
In the study, 120 participants in the left side lying position (control group).
Other Names:
  • (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right Side Lying Post NST (3)
Time Frame: before NST
Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.
before NST

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right Side Lying
Time Frame: NST instant
Blood Pressure (Systolic)
NST instant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right Side Lying
Time Frame: post NST (NST time:1 minute)
Blood Pressure (Systolic)
post NST (NST time:1 minute)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Principal Investigator: TUĞBA YILMAZ ESENCAN, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NST (Other Grant/Funding Number: The Neurological Society of Thailand)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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