Pregnancy RelatedNCT05778435

The Effect of Wireless Fetal Monitoring System on Comfort, Pain and Satisfaction

A study testing wireless fetal monitoring system in people with Pregnancy Related, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Wireless EFM shortens labor duration, increases birth satisfaction, and reduces perceived pain during labor. With wireless EFM, comfort in labor increases and higher labor comfort increases birth satisfaction. As perceived pain in labor decreases, birth satisfaction increases. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy Related
What is being tested?: wireless fetal monitoring system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 11 Sep 2021to 3 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

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 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Pregnant women who are willing to participate in the study,
Aged 18-40 years,
Having a healthy pregnancy,
With a gestational age of > 37+0 weeks,
With a cervical dilatation of 4-5 cm,
With a singleton pregnancy,

Show all 9Show fewer

With a live fetus,
Can speak Turkish,
Do not have comprehension, perception, and communication problems participated in the study.

Who cannot join

Pregnant women who did not comply with the study had communication problems,
Had complications,
Needed urgent cesarean delivery and wanted to withdraw from the study were excluded from the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Cumhuriyet University
Sivas, 58140

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of The Wireless Fetal Monitoring Used During Birth On The Women's Comfort, Labour Pain And Birth Satisfaction

Read the detailed description

Problem Wired Electronic Fetal Monitoring (EFM) limits the woman's freedom of movement during labor, causes inability to cope with labor pain, lack of comfort, and a decrease in labor satisfaction.

Background While EFM is performed as wired and wireless in the antepartum and intrapartum periods, wired application is common in the world and in our country.

Aim This randomized controlled study was conducted to evaluate the effect of the wireless fetal monitoring, which is used during birth, on the woman's comfort, labor pain and birth satisfaction.

Methods The study population consisted of 88 women, divided into two groups the experimental group (n=44) and the control group (n=44). The data were collected with the Personal Information Form, Childbirth Comfort Questionnaire (CCQ), Visual Pain Scale (VAS), and Birth Satisfaction Scale-Revised (BSS-R). During the intrapartum period, the wireless fetal monitoring system was used in the experimental group and the wired fetal monitoring system was used in the control group.

Conditions: Pregnancy Related
Being tested: wireless fetal monitoring system
Keywords: Pain, Birth, Chilbirth Satisfaction, Wireless Fetal Monitoring, Comfort
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

wireless fetal monitoring systemDevice
The wireless fetal monitoring system shortens the period of labor by enabling the woman to be more mobile during the intrapartum period.

Study groups in NCT05778435
Study group	Role	What they receive
wireless fetal monitoring group	Experimental	wireless fetal monitoring system was applied to the experimental group Receives: Device: wireless fetal monitoring system
Control group	No intervention	Standard wired fetal monitoring system was applied to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Childbirth Comfort Questionnaire
The participants rated the questionnaire through a Likert-type scale ranging from 1 to 5. The scores that can be obtained from the scale vary from 9 to 45. Higher scores indicate higher comfort during labor, whereas lower scores mean lower comfort
Measured: When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the CCQ were filled out by the researcher between contractions, when the pregnant feels good.
Visual Analogue Scale
To measure the level of the pain, mostly a 10-cm-long vertical or horizontal line labeled from "No pain" to "Unbearable pain" is used. The participants are asked to mark their pain level on the line by a line, dot, or simply showing. The distance between the "no pain" point and the marked point indicates the level of pain
Measured: When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the VAS were filled out by the researcher between contractions, when the pregnant feels good.
Birth Satisfaction Scale-Revised
The lowest and the highest scores that can be obtained from the scale were 0 and 40, respectively. Higher scores indicate higher satisfaction. Satisfaction is classified as low satisfaction (0-13), medium satisfaction (14-27), and high satisfaction (28-40). The scale is implemented within the first three days after delivery birth.
Measured: The BSS-R was conducted 1 h after the mother was taken from the labor room to the gynecology and obstetrics service. The time required for the rest need of the postpartum mother, to meet her personal needs and breastfeed her baby was also provided

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 20213 Dec 2021

First posted21 Mar 2023
Study start11 Sep 2021
Primary completion3 Dec 2021
Study completion3 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Pregnancy RelatedStudies 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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05778435
Sponsor's protocol ID: TRTOKAT60
Status last verified: Mar 2023
First submitted: 28 Dec 2022
Last updated: 21 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is not a plan to make IPD available.

Publications

van den Heuvel JFM, Teunis CJ, Franx A, Crombag NMTH, Bekker MN. Home-based telemonitoring versus hospital admission in high risk pregnancies: a qualitative study on women's experiences. BMC Pregnancy Childbirth. 2020 Feb 4;20(1):77. doi: 10.1186/s12884-020-2779-4.
PubMed 32019499
Menihan CA, Kopel E. Electronic Fetal Monitoring: Concepts and Applications. 2nd Ed. Chapter 2. Philadelphia, Lippincott: Williams&Wilkins; 2008.
Monson M, Heuser C, Einerson BD, Esplin I, Snow G, Varner M, Esplin MS. Evaluation of an external fetal electrocardiogram monitoring system: a randomized controlled trial. Am J Obstet Gynecol. 2020 Aug;223(2):244.e1-244.e12. doi: 10.1016/j.ajog.2020.02.012. Epub 2020 Feb 20.
PubMed 32087146
Alfirevic Z, Stampalija T, Medley N. Fetal and umbilical Doppler ultrasound in normal pregnancy. Cochrane Database Syst Rev. 2015 Apr 15;2015(4):CD001450. doi: 10.1002/14651858.CD001450.pub4.
PubMed 25874722
Mugyenyi GR, Atukunda EC, Ngonzi J, Boatin A, Wylie BJ, Haberer JE. Functionality and acceptability of a wireless fetal heart rate monitoring device in term pregnant women in rural Southwestern Uganda. BMC Pregnancy Childbirth. 2017 Jun 8;17(1):178. doi: 10.1186/s12884-017-1361-1.
PubMed 28595604
van den Heuvel JFM, Ganzevoort W, De Haan-Jebbink JM, van der Ham DP, Deurloo KL, Seeber L, Franx A, Bekker MN. HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial. BMJ Open. 2019 Oct 28;9(10):e031700. doi: 10.1136/bmjopen-2019-031700.
PubMed 31662396
Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17.
PubMed 33345967
Rubarth LB, Schoening AM, Cosimano A, Sandhurst H. Women's experience of hospitalized bed rest during high-risk pregnancy. J Obstet Gynecol Neonatal Nurs. 2012 May-Jun;41(3):398-407. doi: 10.1111/j.1552-6909.2012.01349.x. Epub 2012 Apr 26.
PubMed 22537349
Kent RA, Yazbek M, Heyns T, Coetzee I. The support needs of high-risk antenatal patients in prolonged hospitalisation. Midwifery. 2015 Jan;31(1):164-9. doi: 10.1016/j.midw.2014.08.003. Epub 2014 Aug 15.
PubMed 25193792
Lawrence A, Lewis L, Hofmeyr GJ, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2013 Oct 9;2013(10):CD003934. doi: 10.1002/14651858.CD003934.pub4.
PubMed 24105444
Nguyen K, Bamgbose E, Cox BP, Huang SP, Mierzwa A, Hutchins S, Caso B, Culjat M, Connelly C, Lacoursiere DY, Singh RS. Wearable Fetal Monitoring Solution for Improved Mobility During Labor & Delivery. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4397-4400. doi: 10.1109/EMBC.2018.8513321.
PubMed 30441327
Goncu Serhatlioglu S, Karahan N, Hollins Martin CJ, Martin CR. Construct and content validity of the Turkish Birth Satisfaction Scale - Revised (T-BSS-R). J Reprod Infant Psychol. 2018 Jul;36(3):235-245. doi: 10.1080/02646838.2018.1443322. Epub 2018 Mar 19.
PubMed 29553295
Ryu D, Kim DH, Price JT, Lee JY, Chung HU, Allen E, Walter JR, Jeong H, Cao J, Kulikova E, Abu-Zayed H, Lee R, Martell KL, Zhang M, Kampmeier BR, Hill M, Lee J, Kim E, Park Y, Jang H, Arafa H, Liu C, Chisembele M, Vwalika B, Sindano N, Spelke MB, Paller AS, Premkumar A, Grobman WA, Stringer JSA, Rogers JA, Xu S. Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2100466118. doi: 10.1073/pnas.2100466118.
PubMed 33972445
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Alfirevic Z, Devane D, Gyte GM. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD006066. doi: 10.1002/14651858.CD006066.
PubMed 16856111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy

All Pregnancy Related trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect Of The Wireless Fetal Monitoring Used During Birth On The Women's Comfort, Labour Pain And Birth Satisfaction
ClinicalTrials.gov ID: NCT05778435
Acronym / sponsor ID: TRTOKAT60
Conditions: Pregnancy Related
Keywords: Pain, Birth, Chilbirth Satisfaction, Wireless Fetal Monitoring, Comfort
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Tokat Gaziosmanpasa UniversityUniversity, hospital or other
Study start: 11 Sep 2021 (actual)
Primary completion: 3 Dec 2021 (actual)
Study completion: 3 Dec 2021 (actual)
First posted: 21 Mar 2023 (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.

Detailed description

Problem Wired Electronic Fetal Monitoring (EFM) limits the woman's freedom of movement during labor, causes inability to cope with labor pain, lack of comfort, and a decrease in labor satisfaction.

Background While EFM is performed as wired and wireless in the antepartum and intrapartum periods, wired application is common in the world and in our country.

Aim This randomized controlled study was conducted to evaluate the effect of the wireless fetal monitoring, which is used during birth, on the woman's comfort, labor pain and birth satisfaction.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
wireless fetal monitoring group	Experimental	Device: wireless fetal monitoring systemwireless fetal monitoring system was applied to the experimental group
Control group	No intervention	–Standard wired fetal monitoring system was applied to the control group.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Pregnant women who are willing to participate in the study,
Aged 18-40 years,
Having a healthy pregnancy,
With a gestational age of > 37+0 weeks,
With a cervical dilatation of 4-5 cm,

Key exclusion criteria (3 listed)

Pregnant women who did not comply with the study had communication problems,
Had complications,
Needed urgent cesarean delivery and wanted to withdraw from the study were excluded from 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
wireless fetal monitoring systemThe wireless fetal monitoring system shortens the period of labor by enabling the woman to be more mobile during the intrapartum period.	Device	wireless fetal monitoring group

Primary outcome

Childbirth Comfort Questionnaire
Time frame: When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the CCQ were filled out by the researcher between contractions, when the pregnant feels good.
The participants rated the questionnaire through a Likert-type scale ranging from 1 to 5. The scores that can be obtained from the scale vary from 9 to 45. Higher scores indicate higher comfort during labor, whereas lower scores mean lower comfort
Visual Analogue Scale
Time frame: When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the VAS were filled out by the researcher between contractions, when the pregnant feels good.
To measure the level of the pain, mostly a 10-cm-long vertical or horizontal line labeled from "No pain" to "Unbearable pain" is used. The participants are asked to mark their pain level on the line by a line, dot, or simply showing. The distance between the "no pain" point and the marked point indicates the level of pain
Birth Satisfaction Scale-Revised
Time frame: The BSS-R was conducted 1 h after the mother was taken from the labor room to the gynecology and obstetrics service. The time required for the rest need of the postpartum mother, to meet her personal needs and breastfeed her baby was also provided
The lowest and the highest scores that can be obtained from the scale were 0 and 40, respectively. Higher scores indicate higher satisfaction. Satisfaction is classified as low satisfaction (0-13), medium satisfaction (14-27), and high satisfaction (28-40). The scale is implemented within the first three days after delivery birth.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Background: PubMed 32019499van den Heuvel JFM, Teunis CJ, Franx A, Crombag NMTH, Bekker MN. Home-based telemonitoring versus hospital admission in high risk pregnancies: a qualitative study on women's experiences. BMC Pregnancy Childbirth. 2020 Feb 4;20(1):77. doi: 10.1186/s12884-020-2779-4.
BackgroundMenihan CA, Kopel E. Electronic Fetal Monitoring: Concepts and Applications. 2nd Ed. Chapter 2. Philadelphia, Lippincott: Williams&Wilkins; 2008.
Background: PubMed 32087146Monson M, Heuser C, Einerson BD, Esplin I, Snow G, Varner M, Esplin MS. Evaluation of an external fetal electrocardiogram monitoring system: a randomized controlled trial. Am J Obstet Gynecol. 2020 Aug;223(2):244.e1-244.e12. doi: 10.1016/j.ajog.2020.02.012. Epub 2020 Feb 20.
Background: PubMed 25874722Alfirevic Z, Stampalija T, Medley N. Fetal and umbilical Doppler ultrasound in normal pregnancy. Cochrane Database Syst Rev. 2015 Apr 15;2015(4):CD001450. doi: 10.1002/14651858.CD001450.pub4.
Background: PubMed 28595604Mugyenyi GR, Atukunda EC, Ngonzi J, Boatin A, Wylie BJ, Haberer JE. Functionality and acceptability of a wireless fetal heart rate monitoring device in term pregnant women in rural Southwestern Uganda. BMC Pregnancy Childbirth. 2017 Jun 8;17(1):178. doi: 10.1186/s12884-017-1361-1.
Background: PubMed 31662396van den Heuvel JFM, Ganzevoort W, De Haan-Jebbink JM, van der Ham DP, Deurloo KL, Seeber L, Franx A, Bekker MN. HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial. BMJ Open. 2019 Oct 28;9(10):e031700. doi: 10.1136/bmjopen-2019-031700.
Background: PubMed 33345967Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17.
Background: PubMed 22537349Rubarth LB, Schoening AM, Cosimano A, Sandhurst H. Women's experience of hospitalized bed rest during high-risk pregnancy. J Obstet Gynecol Neonatal Nurs. 2012 May-Jun;41(3):398-407. doi: 10.1111/j.1552-6909.2012.01349.x. Epub 2012 Apr 26.
Background: PubMed 25193792Kent RA, Yazbek M, Heyns T, Coetzee I. The support needs of high-risk antenatal patients in prolonged hospitalisation. Midwifery. 2015 Jan;31(1):164-9. doi: 10.1016/j.midw.2014.08.003. Epub 2014 Aug 15.
Background: PubMed 24105444Lawrence A, Lewis L, Hofmeyr GJ, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2013 Oct 9;2013(10):CD003934. doi: 10.1002/14651858.CD003934.pub4.
Background: PubMed 30441327Nguyen K, Bamgbose E, Cox BP, Huang SP, Mierzwa A, Hutchins S, Caso B, Culjat M, Connelly C, Lacoursiere DY, Singh RS. Wearable Fetal Monitoring Solution for Improved Mobility During Labor & Delivery. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4397-4400. doi: 10.1109/EMBC.2018.8513321.
Background: PubMed 29553295Goncu Serhatlioglu S, Karahan N, Hollins Martin CJ, Martin CR. Construct and content validity of the Turkish Birth Satisfaction Scale - Revised (T-BSS-R). J Reprod Infant Psychol. 2018 Jul;36(3):235-245. doi: 10.1080/02646838.2018.1443322. Epub 2018 Mar 19.
Individual participant dataSharing planned: No. There is not a plan to make IPD available.

Related trials for Pregnancy Related

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy

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.

Gülseren Dağlar principal investigator

Cumhuriyet University

Demet Çakır principal investigator

Cumhuriyet 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 wireless fetal monitoring system in people with Pregnancy Related, 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 9 inclusion and 3 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 21 Mar 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Childbirth Comfort Questionnaire (time frame: When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the CCQ were filled out by the researcher between contractions, when the pregnant feels good.). The study lists 3 primary outcomes in all. 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 NCT05778435, which also lists 29 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 21 Mar 2023.