BirthNCT07233187
The Effect of Wireless Electronic Fetal Monitoring on Labor Pain and Birth Experiences
A study testing Continuous Wireless EFM Group in people with Birth and Intrapartum, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study is using Electronic Fetal Monitoring (EFM) to assess fetal health in pregnant women in labor. This will be compared with continuous wired EFM and continuous wireless EFM. The effects of wireless and continuous wireless EFM on labor pain levels and labor experiences will be measured. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, Intrapartum
- What is being tested?
- Continuous Wireless EFM Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study included healthy primiparous or multiparous pregnant women who agreed to participate in the study, were between the ages of 18 and 35, had a gestational age greater than 37+0, had cervical dilation greater than 4 cm, had a single, live fetus, were not using uterotonic agents, spoke Turkish, had no comprehension, perception, or communication problems, and were healthy.
Who cannot join
- Pregnant women who were diagnosed with a risky pregnancy, who were illiterate, who had a contagious disease, or who had a risky disease were not included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Tokat Province, 60000
melek aytekin, Research Assistant Doctor, 05071616044, mlksn90@gmail.com
Melek Şen Aytekin, Research Assistant
About this study
Official title: The Effect of Continuous Wireless Fetal Monitoring During the Intrapartum Period on Labor Pain and Birth Experience: A Randomized Controlled Single-Blind Study
This study is using Electronic Fetal Monitoring (EFM) to assess fetal health in pregnant women in labor. This will be compared with continuous wired EFM and continuous wireless EFM. The effects of wireless and continuous wireless EFM on labor pain levels and labor experiences will be measured.
Read the detailed description
In this study, Electronic Fetal Monitoring (EFM) is being applied to pregnant women in labor to assess fetal health. This procedure is typically performed in hospitals using a continuous wired EFM. During this period, women are forced to lie down constantly and cannot use active methods to cope with pain. Therefore, using a wireless EFM may be an approach that allows for continuous assessment while also supporting women's activity. Therefore, a comparison will be made between continuous wired EFM and continuous wireless EFM. During labor, pain levels will be assessed using the Visual Analog Scale when cervical dilation is between 8 and 10 cm. After the first hour postpartum, the labor experience of the postpartum woman will be collected using the Birth Experiences Scale.
- Conditions
- Birth, Intrapartum
- Being tested
- Continuous Wireless EFM Group
- Keywords
- Fetal Monitoring, intrapartum, pain, birth experience, Continuous Wireless Fetal Monitoring
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Wireless EFM GroupOther
Pregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Wired EFM Group | No intervention | In routine practice, fetal health assessments for pregnant women presenting for labor are conducted using a continuous wired EFM. Pregnant women in this group will not receive any interventions other than routine procedures. Because pregnant women are constantly connected to the EFM, the EFM will be removed and reconnected when necessary, such as when going to the toilet. |
| Continuous Wireless EFM Group | Experimental | Pregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM. Receives: Other: Continuous Wireless EFM Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Experience Questionnaire
The Birth Experience Questionnaire (CEQ), developed by Dencker and colleagues in 2010, was adapted into Turkish by Mamuk and colleagues in 2019. Developed to measure women's birth experiences across various dimensions, the scale has four subscales and 22 items. It consists of the following subscales: Birth Process (8 items), Professional Assistance/Support (5 items), Perceived Safety/Memories (6 items), and Participation in Decisions (3 items).
Measured: 1 hour after the end of labor
The Visual Acuity Scale
This is a horizontal or vertical line, usually 10 cm long, used to assess pain intensity. It begins with "No Pain" and ends with "Unbearable Pain." The patient marks the appropriate location on this line based on the pain they experience. The VAS is used to convert some values that cannot be measured numerically into numerical values. The two extremes of the parameter to be evaluated are written at either end of a 100 mm line, and the patient is asked to indicate where their own condition aligns with this line by drawing a line, placing a dot, or pointing. For example, for pain, "No pain at all" is written at one end, and "Extreme pain at the other end," and the patient marks their current condition on this line. According to this scale, the patient is asked to rate whether they have pain or not, and if so, to rate it on a scale of 0-10. According to this score, pain intensity is considered mild pain at <3, moderate pain at 3-6, and severe pain at >6. The distance from the point of
Measured: Determining the pain level of pregnant women will be completed within 5 minutes when cervical dilation is 8-10 cm.
Secondary outcomes (1)
Personal Information Form
This form, which questions the introductory characteristics of pregnant women, consists of a total of 23 questions, 6 of which are to determine the socio-demographic and obstetric characteristics of pregnant women, 8 questions to learn their obstetric information and 9 questions about birth experience.
Measured: The data will be collected 5 minutes after the pregnant woman is included in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Şen Aytekin, Tokat Gaziosmanpasa University
- Investigators
- Melek Şen Aytekin, Research Assistant, Principal investigator, Tokat Gaziosmanpasa UniversityDemet Çakır, Assistant Professor, Study chair, Tokat Gaziosmanpasa UniversityAyşenur Kahraman, Research Assistant, Study chair, Tokat Gaziosmanpasa UniversityEmine Aksüt Akçay, Study chair, Kahramanmaras Sütcü İmam Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233187
- Sponsor's protocol ID
- GaziosmanpasaU-EBE-MŞA-04
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Wireless Fetal Monitoring During the Intrapartum Period on Labor Pain and Birth Experience: A Randomized Controlled Single-Blind Study
- ClinicalTrials.gov ID
- NCT07233187
- Acronym / sponsor ID
- GaziosmanpasaU-EBE-MŞA-04
- Conditions
- Birth, Intrapartum
- Keywords
- Fetal Monitoring, intrapartum, pain, birth experience, Continuous Wireless Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is using Electronic Fetal Monitoring (EFM) to assess fetal health in pregnant women in labor. This will be compared with continuous wired EFM and continuous wireless EFM. The effects of wireless and continuous wireless EFM on labor pain levels and labor experiences will be measured.
Detailed description
In this study, Electronic Fetal Monitoring (EFM) is being applied to pregnant women in labor to assess fetal health. This procedure is typically performed in hospitals using a continuous wired EFM. During this period, women are forced to lie down constantly and cannot use active methods to cope with pain. Therefore, using a wireless EFM may be an approach that allows for continuous assessment while also supporting women's activity. Therefore, a comparison will be made between continuous wired EFM and continuous wireless EFM. During labor, pain levels will be assessed using the Visual Analog Scale when cervical dilation is between 8 and 10 cm. After the first hour postpartum, the labor experience of the postpartum woman will be collected using the Birth Experiences Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Wired EFM Group | No intervention | –In routine practice, fetal health assessments for pregnant women presenting for labor are conducted using a continuous wired EFM. Pregnant women in this group will not receive any interventions other than routine procedures. Because pregnant women are constantly connected to the EFM, the EFM will be removed and reconnected when necessary, such as when going to the toilet. |
| Continuous Wireless EFM Group | Experimental | Other: Continuous Wireless EFM GroupPregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study included healthy primiparous or multiparous pregnant women who agreed to participate in the study, were between the ages of 18 and 35, had a gestational age greater than 37+0, had cervical dilation greater than 4 cm, had a single, live fetus, were not using uterotonic agents, spoke Turkish, had no comprehension, perception, or communication problems, and were healthy.
Key exclusion criteria (1 listed)
- Pregnant women who were diagnosed with a risky pregnancy, who were illiterate, who had a contagious disease, or who had a risky disease were not included in the study.
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 |
|---|---|---|
| Continuous Wireless EFM GroupPregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM. | Other | Continuous Wireless EFM Group |
Primary outcome
Birth Experience Questionnaire
Time frame: 1 hour after the end of labor
The Birth Experience Questionnaire (CEQ), developed by Dencker and colleagues in 2010, was adapted into Turkish by Mamuk and colleagues in 2019. Developed to measure women's birth experiences across various dimensions, the scale has four subscales and 22 items. It consists of the following subscales: Birth Process (8 items), Professional Assistance/Support (5 items), Perceived Safety/Memories (6 items), and Participation in Decisions (3 items).
The Visual Acuity Scale
Time frame: Determining the pain level of pregnant women will be completed within 5 minutes when cervical dilation is 8-10 cm.
This is a horizontal or vertical line, usually 10 cm long, used to assess pain intensity. It begins with "No Pain" and ends with "Unbearable Pain." The patient marks the appropriate location on this line based on the pain they experience. The VAS is used to convert some values that cannot be measured numerically into numerical values. The two extremes of the parameter to be evaluated are written at either end of a 100 mm line, and the patient is asked to indicate where their own condition aligns with this line by drawing a line, placing a dot, or pointing. For example, for pain, "No pain at all" is written at one end, and "Extreme pain at the other end," and the patient marks their current condition on this line. According to this scale, the patient is asked to rate whether they have pain or not, and if so, to rate it on a scale of 0-10. According to this score, pain intensity is considered mild pain at <3, moderate pain at 3-6, and severe pain at >6. The distance from the point of
1 secondary outcome
Personal Information Form
Time frame: The data will be collected 5 minutes after the pregnant woman is included in the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- 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.
Melek Şen Aytekin, Research Assistant principal investigator
Tokat Gaziosmanpasa University
Demet Çakır, Assistant Professor study chair
Tokat Gaziosmanpasa University
Ayşenur Kahraman, Research Assistant study chair
Tokat Gaziosmanpasa 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 Continuous Wireless EFM Group in people with Birth and Intrapartum, run by Tokat Gaziosmanpasa 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 1 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: opening soon, as of the sponsor's last update on 18 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melek Şen Aytekin, Research Assistant Doctor (+905071616044, meleksenaytekin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth Experience Questionnaire (time frame: 1 hour after the end of labor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.