Fetal MonitoringNCT05863156
Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring
A study testing Right side lying position, Semi Fowler and left side lying position in people with Fetal Monitoring and Patient Comfort, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Monitoring, Patient Comfort, Maternal Health
- What is being tested?
- Right side lying position, Semi Fowler and left side lying position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- The pregnant woman does not accept the recommended application position.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Monitoring, Patient Comfort, Maternal Health
- Being tested
- Right side lying position, Semi Fowler, left side lying position
- Keywords
- Fetal Monitoring, Patient Comfort, Maternal Health, Midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right side lying positionDiagnostic test
Also called (intervention 1)
In the study, 60 participants were placed in the right side lying position (intervention 1)
Semi FowlerDiagnostic test
Also called (intervention 2)
In the study, 60 participants in the semi-sitting position (intervention 2)
left side lying positionDiagnostic test
Also called (control group)
In the study, 120 participants in the left side lying position (control group).
| Study group | Role | What they receive |
|---|---|---|
| intervention 1 | Experimental | electro fetal monitoring Receives: Diagnostic Test: Right side lying position; Diagnostic Test: Semi Fowler; Diagnostic Test: left side lying position |
| intervention 2 | Experimental | electro fetal monitoring Receives: Diagnostic Test: Right side lying position; Diagnostic Test: Semi Fowler; Diagnostic Test: left side lying position |
| control group | Experimental | electro fetal monitoring Receives: Diagnostic Test: Right side lying position; Diagnostic Test: Semi Fowler; Diagnostic Test: left side lying position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Side Lying Post NST (3)
Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.
Measured: before NST
Secondary outcomes (1)
Right Side Lying
Blood Pressure (Systolic)
Measured: NST instant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start30 Dec 2021
- Primary completion30 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba YILMAZ ESENCAN, Uskudar University
- Investigators
- TUĞBA YILMAZ ESENCAN, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863156
- Sponsor's protocol ID
- NST
- Status last verified
- Feb 2025
- First submitted
- 28 Mar 2023
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29772936Yilmaz 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.
PubMed 39773730
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring on Maternal Comfort, Maternal Blood Pressure and Fetal Health
- ClinicalTrials.gov ID
- NCT05863156
- Acronym / sponsor ID
- NST
- Conditions
- Fetal Monitoring, Patient Comfort, Maternal Health
- Keywords
- Fetal Monitoring, Patient Comfort, Maternal Health, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention 1 | Experimental | Diagnostic Test: Right side lying position, Diagnostic Test: Semi Fowler, Diagnostic Test: left side lying positionelectro fetal monitoring |
| intervention 2 | Experimental | Diagnostic Test: Right side lying position, Diagnostic Test: Semi Fowler, Diagnostic Test: left side lying positionelectro fetal monitoring |
| control group | Experimental | Diagnostic Test: Right side lying position, Diagnostic Test: Semi Fowler, Diagnostic Test: left side lying positionelectro fetal monitoring |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- The pregnant woman does not accept the recommended application position.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right side lying positionAlso: (intervention 1)In the study, 60 participants were placed in the right side lying position (intervention 1) | Diagnostic test | control group, intervention 1, intervention 2 |
| Semi FowlerAlso: (intervention 2)In the study, 60 participants in the semi-sitting position (intervention 2) | Diagnostic test | control group, intervention 1, intervention 2 |
| left side lying positionAlso: (control group)In the study, 120 participants in the left side lying position (control group). | Diagnostic test | control group, intervention 1, intervention 2 |
Primary outcome
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.
1 secondary outcome
Right Side Lying
Time frame: NST instant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29772936Humphries 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.
- Derived from this study: PubMed 39773730Yilmaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUĞBA YILMAZ ESENCAN principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right side lying position, Semi Fowler and left side lying position in people with Fetal Monitoring and Patient Comfort, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Side Lying Post NST (3) (time frame: before NST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.