NCT05863156

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
305

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 3, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

March 28, 2023

Results QC Date

May 28, 2023

Last Update Submit

February 7, 2025

Conditions

Keywords

Fetal MonitoringPatient ComfortMaternal HealthMidwifery

Outcome Measures

Primary Outcomes (1)

  • Right Side Lying Post NST (3)

    Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.

    before NST

Secondary Outcomes (1)

  • Right Side Lying

    NST instant

Other Outcomes (1)

  • Right Side Lying

    post NST (NST time:1 minute)

Study Arms (3)

intervention 1

EXPERIMENTAL

electro fetal monitoring

Diagnostic Test: Right side lying positionDiagnostic Test: Semi FowlerDiagnostic Test: left side lying position

intervention 2

EXPERIMENTAL

electro fetal monitoring

Diagnostic Test: Right side lying positionDiagnostic Test: Semi FowlerDiagnostic Test: left side lying position

control group

EXPERIMENTAL

electro fetal monitoring

Diagnostic Test: Right side lying positionDiagnostic Test: Semi FowlerDiagnostic Test: left side lying position

Interventions

In the study, 60 participants were placed in the right side lying position (intervention 1)

Also known as: (intervention 1)
control groupintervention 1intervention 2
Semi FowlerDIAGNOSTIC_TEST

In the study, 60 participants in the semi-sitting position (intervention 2)

Also known as: (intervention 2)
control groupintervention 1intervention 2

In the study, 120 participants in the left side lying position (control group).

Also known as: (control group)
control groupintervention 1intervention 2

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- The pregnant woman does not accept the recommended application position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar Univercity

Istanbul, Ümraniye, 34000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 29772936BACKGROUND
  • Yilmaz Esencan T, Demir Yildirim A, Sagiroglu E. Effects of maternal positions in electronic fetal monitoring: a randomised controlled trial. BMC Nurs. 2025 Jan 7;24(1):22. doi: 10.1186/s12912-024-02654-w.

Limitations and Caveats

In the limited number of similar studies in the literature, it has been the supine position that has been examined but this has not produced robust results. For this reason, differing from other studies, the present study sought to examine the effects of the right lateral position and BMI on maternal blood pressure and fetal health.

Results Point of Contact

Title
Tugba YILMAZ ESENCAN
Organization
Uskudar Univercity

Study Officials

  • TUĞBA YILMAZ ESENCAN

    Uskudar University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-dean

Study Record Dates

First Submitted

March 28, 2023

First Posted

May 17, 2023

Study Start

December 30, 2021

Primary Completion

July 30, 2022

Study Completion

November 30, 2022

Last Updated

March 3, 2025

Results First Posted

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations