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

• Conditions: Pregnancy
• Interventions: Procedure: maternal abdominal pressure

• Registration Number: NCT02691884
• Lead Sponsor: Meir Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-21
• Study First Submitted QC: 2016-02-21
• Study First Posted: 2016-02-25
• Study Start: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-01
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients before/after Pressure Exertion	maternal abdominal pressure	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.

Primary Outcome Measures

Name	Time	Method
Changes in fetal baseline heart rate, including accelerations and decelerations	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

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kefar Sava, Israel