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The Effect of Pressure Exerted on the Maternal Abdominal Wall by the Ultrasound Probe on Fetal Heart Rate

The Effect of Pressure Exerted on the Maternal Abdominal Wall by the Ultrasound Probe on Fetal Heart Rate

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02691884
Enrollment
100
Registered
2016-02-25
Start date
2016-03-31
Completion date
2020-04-30
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Heart Rate, Fetal, Electronic Fetal Monitoring, Transducers, Pressure

Brief 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).

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.

Interventions

PROCEDUREmaternal abdominal pressure

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.

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* over 18 years of age * singleton pregnancy * term (37-41 weeks of gestation) * consented * undergoing routine cardiotocography (CTG)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in fetal baseline heart rate, including accelerations and decelerationsimmediately after applying pressure to the maternal abdomenpressure will be applied after the 20th minute of CTG monitoring and for a total of 5 minutes

Countries

Israel

Contacts

Primary ContactTal Weissbach, MD
ferbyt@gmail.com972-54-6250299
Backup ContactRonnie Tepper, MD
tepper@clalit.org.il972-9-7472872

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026