NCT02691884

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

February 21, 2016

Last Update Submit

March 7, 2016

Conditions

Pregnancy

Keywords

Heart Rate, FetalElectronic Fetal MonitoringTransducers, Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Procedure: maternal abdominal pressure

Interventions

maternal abdominal pressurePROCEDURE

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.

Patients before/after Pressure Exertion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kefar Sava, 4428164, Israel

Location

Related Publications (4)

  • 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.

    PMID: 12420840RESULT

  • 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.

    PMID: 21064194RESULT

  • 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. doi: 10.1111/j.1471-0528.1990.tb16250.x. No abstract available.

    PMID: 2205291RESULT

  • 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. 2017 Jan;38(1):44-50. doi: 10.1055/s-0035-1553332. Epub 2015 Sep 30.

    PMID: 26422667RESULT

Study Officials

  • Tal Weissbach, MD

    Meir Medical Center, Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Weissbach, MD

CONTACT

972-54-6250299ferbyt@gmail.com

Ronnie Tepper, MD

CONTACT

972-9-7472872tepper@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2016

First Posted

February 25, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2018

Study Completion

April 1, 2020

Last Updated

March 8, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations

IL(1)