PregnancyNCT02691884
The Effect of Pressure Exerted on the Maternal Abdominal Wall by the Ultrasound Probe on Fetal Heart Rate
An observational study of Pregnancy, run by Meir Medical Center at 1 site in Israel.
Trial summary
The aim of the study is to assess the change of fetal heart rate in response to the amount of pressure exerted on the maternal abdomen. The amount of pressure will be quantified using an electronic pressure sensor (FSR 400- Round Force Sensor, Interlink). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- maternal abdominal pressure
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Apr 2020
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Term singleton pregnancies in patients over 18 years of age, undergoing routine CTG for various indications- growth monitoring, gestational diabetes monitoring, post term, etc.
Who may be able to join
- over 18 years of age
- singleton pregnancy
- term (37-41 weeks of gestation)
- consented
- undergoing routine cardiotocography (CTG)
Who cannot join
- referred to the ER due to non reassuring fetal heart rate (NRFHR)
- recognition of NRFHR pattern on CTG at the ER
- self reporting of reduced fetal movement perception
- unconsented patient
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center
Kefar Sava, 4428164
Tal Weissbach, MD, 972-546-250299, ferbyt@gmail.com
Ronnie Tepper, MD, 972-9-7472872, tepper@clalit.org.il
About this study
The aim of the study is to assess the change of fetal heart rate in response to the amount of pressure exerted on the maternal abdomen. The amount of pressure will be quantified using an electronic pressure sensor (FSR 400- Round Force Sensor, Interlink).
Read the detailed description
Previous studies have shown a fetal cardiovascular effect to the pressure exerted on the maternal abdomen. Our null hypothesis is that there is a correlation between fetal heart rate changes and pressure exerted on the fetus through the maternal abdomen.
Women at term pregnancy coming for a routine cardiotocography monitor, will undergo 5 minutes of quantified pressure on their abdomen, using the electronic pressure sensor. The amount of pressure will be recorded as well as the fetal heartbeat baseline and changes to the heart rate following the application of pressure.
- Conditions
- Pregnancy
- Being tested
- maternal abdominal pressure
- Keywords
- Heart Rate, Fetal, Electronic Fetal Monitoring, Transducers, Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal abdominal pressureProcedure or surgery
The fetal cardiac response of either acceleration, deceleration or no change at all to the fetal heart- will be recorded and later on analyzed in reference to the amount of pressure applied from the 20th minute of CTG and for 5 minutes, using the FSR 400 sensor.
| Study group | Role | What they receive |
|---|---|---|
| Patients before/after Pressure Exertion | 100 pregnant patients at term in low risk pregnancies, undergoing a routine cardiotocography, will experience different amounts of manual pressure on their abdomen. The amount of pressure applied will be recorded and the fetal heart rate will be compared before and at the time of maternal abdominal pressure. Receives: Procedure: maternal abdominal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fetal baseline heart rate, including accelerations and decelerations
pressure will be applied after the 20th minute of CTG monitoring and for a total of 5 minutes
Measured: immediately after applying pressure to the maternal abdomen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tal Weissbach, MD, Principal investigator, Meir Medical Center, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691884
- Sponsor's protocol ID
- 0149-14-MMC
- Status last verified
- Feb 2016
- First submitted
- 21 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Ramon y Cajal CL. Umbilical vein and middle cerebral artery blood flow response to partial occlusion by external compression of the umbilical vein (pressure test). J Matern Fetal Neonatal Med. 2002 Aug;12(2):104-11. doi: 10.1080/jmf.12.2.104.111.
PubMed 12420840Su YM, Lv GR, Chen XK, Li SH, Lin HT. Ultrasound probe pressure but not maternal Valsalva maneuver alters Doppler parameters during fetal middle cerebral artery Doppler ultrasonography. Prenat Diagn. 2010 Dec;30(12-13):1192-7. doi: 10.1002/pd.2648.
PubMed 21064194Vyas S, Campbell S, Bower S, Nicolaides KH. Maternal abdominal pressure alters fetal cerebral blood flow. Br J Obstet Gynaecol. 1990 Aug;97(8):740-2. doi: 10.1111/j.1471-0528.1990.tb16250.x. No abstract available.
PubMed 2205291Alpert Y, Ben-Moshe B, Shvalb N, Piura E, Tepper R. The Effect of the Pressure Exerted on the Maternal Abdominal Wall by the US Probe on Fetal MCA Peak Systolic Velocity. Ultraschall Med. 2017 Jan;38(1):44-50. doi: 10.1055/s-0035-1553332. Epub 2015 Sep 30.
PubMed 26422667
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure Exerted on the Maternal Abdominal Wall by the Ultrasound Probe on Fetal Heart Rate
- ClinicalTrials.gov ID
- NCT02691884
- Acronym / sponsor ID
- 0149-14-MMC
- Conditions
- Pregnancy
- Keywords
- Heart Rate, Fetal, Electronic Fetal Monitoring, Transducers, Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- 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.
The aim of the study is to assess the change of fetal heart rate in response to the amount of pressure exerted on the maternal abdomen. The amount of pressure will be quantified using an electronic pressure sensor (FSR 400- Round Force Sensor, Interlink).
Detailed description
Previous studies have shown a fetal cardiovascular effect to the pressure exerted on the maternal abdomen. Our null hypothesis is that there is a correlation between fetal heart rate changes and pressure exerted on the fetus through the maternal abdomen.
Women at term pregnancy coming for a routine cardiotocography monitor, will undergo 5 minutes of quantified pressure on their abdomen, using the electronic pressure sensor. The amount of pressure will be recorded as well as the fetal heartbeat baseline and changes to the heart rate following the application of pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients before/after Pressure Exertion | – | Procedure: maternal abdominal pressure100 pregnant patients at term in low risk pregnancies, undergoing a routine cardiotocography, will experience different amounts of manual pressure on their abdomen. The amount of pressure applied will be recorded and the fetal heart rate will be compared before and at the time of maternal abdominal pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Term singleton pregnancies in patients over 18 years of age, undergoing routine CTG for various indications- growth monitoring, gestational diabetes monitoring, post term, etc.
Key inclusion criteria (5 listed)
- over 18 years of age
- singleton pregnancy
- term (37-41 weeks of gestation)
- consented
- undergoing routine cardiotocography (CTG)
Key exclusion criteria (4 listed)
- referred to the ER due to non reassuring fetal heart rate (NRFHR)
- recognition of NRFHR pattern on CTG at the ER
- self reporting of reduced fetal movement perception
- unconsented patient
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 |
|---|---|---|
| maternal abdominal pressureThe fetal cardiac response of either acceleration, deceleration or no change at all to the fetal heart- will be recorded and later on analyzed in reference to the amount of pressure applied from the 20th minute of CTG and for 5 minutes, using the FSR 400 sensor. | Procedure or surgery | Patients before/after Pressure Exertion |
Primary outcome
Changes in fetal baseline heart rate, including accelerations and decelerations
Time frame: immediately after applying pressure to the maternal abdomen
pressure will be applied after the 20th minute of CTG monitoring and for a total of 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Results publication: PubMed 12420840Ramon y Cajal CL. Umbilical vein and middle cerebral artery blood flow response to partial occlusion by external compression of the umbilical vein (pressure test). J Matern Fetal Neonatal Med. 2002 Aug;12(2):104-11. doi: 10.1080/jmf.12.2.104.111.
- Results publication: PubMed 21064194Su YM, Lv GR, Chen XK, Li SH, Lin HT. Ultrasound probe pressure but not maternal Valsalva maneuver alters Doppler parameters during fetal middle cerebral artery Doppler ultrasonography. Prenat Diagn. 2010 Dec;30(12-13):1192-7. doi: 10.1002/pd.2648.
- Results publication: PubMed 2205291Vyas S, Campbell S, Bower S, Nicolaides KH. Maternal abdominal pressure alters fetal cerebral blood flow. Br J Obstet Gynaecol. 1990 Aug;97(8):740-2. doi: 10.1111/j.1471-0528.1990.tb16250.x. No abstract available.
- Results publication: PubMed 26422667Alpert Y, Ben-Moshe B, Shvalb N, Piura E, Tepper R. The Effect of the Pressure Exerted on the Maternal Abdominal Wall by the US Probe on Fetal MCA Peak Systolic Velocity. Ultraschall Med. 2017 Jan;38(1):44-50. doi: 10.1055/s-0035-1553332. Epub 2015 Sep 30.
- Individual participant dataSharing planned: Yes
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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.
Tal Weissbach, MD principal investigator
Meir Medical Center, Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Meir Medical Center at 1 site in Israel.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tal Weissbach, MD (972-54-6250299, ferbyt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fetal baseline heart rate, including accelerations and decelerations (time frame: immediately after applying pressure to the maternal abdomen). 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 NCT02691884, which also lists 4 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 8 Mar 2016.