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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02691884
• Other study ID #: 0149-14-MMC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 21, 2016
• Last updated: March 7, 2016
• Start date: March 2016
• Est. completion date: April 2020

Study information

• Verified date: February 2016
• Source: Meir Medical Center
• Contact: Tal Weissbach, MD
• Phone: 972-54-6250299
• Email: ferbyt[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

Procedure:
• maternal 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.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kefar Sava

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Alpert 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. 2015 Sep 30. [Epub ahead of print] — View Citation

Ramón 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. — View Citation

Su 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. — View Citation

Vyas 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately after applying pressure to the maternal abdomen	No