Accuracy of Electrohysterography in Assessing Intrauterine Pressure (EHG)

Accuracy of Electrohysterography in Assessing Intrauterine Pressure Compared to Invasive Intrauterine Pressure Catheter

This is a case control prospective study aiming to investigate the accuracy of the electrohysterography (EHG) compared to the intrauterine pressure catheter ( IUPC) that is commonly used in delivery room. Women in second phase of labor - indicated for insertion of IUPC will be asked to participate . Patients that will give their informed consent will be connected both to IUPC and EHG. Medical history and demographic parameters will be taken. The graphs will be compared and analyzed for its frequency and intensity. Delivery mode and fetal well-being will be recorded

Study Overview

• Status: Completed
• Conditions: Uterine Pressure Measurement
• Intervention / Treatment: Device: Electrohysterography

Detailed Description

Fetal monitoring relies on sensors to measure uterine activity and fetal heart rate. Monitoring contractions during labor using the external tocodynamometer relies on measurement of the activity of the abdominal wall and is sometimes unreliable and inaccurate .In cases that there is difficulty in monitoring uterine wall activity through the abdominal wall or increased risk for uterine wall rupture, the commonly used alternative is an invasive intrauterine pressure catheter monitor (IUPC). The IUPC is applied gently behind the head of the fetus after rupture of the membranes spontaneously or artificially into the uterine cavity. Insertion of IUPC monitor may be associated with rare but serious complications including placental abruption and uterine rupture. Non invasive method that will allow for accurate and precise monitoring of the uterine muscle activity is well under search

Lately, a new electrohysterography (EHG) device was introduced as an alternative to the standard intrauterine sensors. (Nemo Healthcare's, Netherlands, PUREtrace). When muscle cells contract, small changes occur in the electrical potential across the cell walls. During contractions, the electrical activity of the uterine muscle can be measured on the maternal abdomen. EHG has been developed to measure the electrical muscle activity of the uterus directly, and by that claiming to offer highly accurate information that correlates with existing invasive measurement methods for uterine contractions. Vlemminx et al, showed EHG also appears to report a more detailed tocographic waveform, like hypertonia or unorganized electrical uterine activity.

The EHG uses a Graphium electrode patch that is applied to the abdomen and records electrical activity non-invasively. Its' module amplifies and converts these signals to a recognized measurement method for uterine activity, as commonly used in fetal monitoring. This measurement is independent of the Body-Mass-Index, abdominal wall thickness or maternal position enabling monitoring obese patients as well.

By using the Graphium electrode patch the patient comfort increases significantly when compared to other measurement methods. The patch is also easy to apply for the medical staff and does not require repositioning over time. It provides a safe and patient-friendly alternative for measuring uterine activity, without the need of changing the existing fetal monitoring infrastructure.

The aim of this study is to investigate the accuracy of the electrohysterography compared to the intrauterine pressure catheter that is commonly used in delivery room in order to promote less invasive management protocols in the future in order to better predict uterine muscle dysfunction during labor.

This is a case control prospective study. Women in second phase of labor - indicated for insertion of intrauterine pressure catheter due to previous uterine scar, multifetal pregnancy, grand multiparity or dysfunctional labor will be asked to participate . Patients that will give their informed consent to participate in the study, will be connected both to IUPC and EHG.Medical history and demographic parameters will be taken. The graphs will be compared and analyzed for its frequency and intensity. Delivery mode and fetal well-being will be recorded

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women at term in second or third phase of labor who are indicated to have an IUPC during active labor

Description

Inclusion Criteria:

• Women at term in second or third phase of labor who are indicated to have an IUPC during active labor

Exclusion Criteria:

• Women not in labor
• Active skin disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with IUPC; Women at term in second or third phase of labor who are indicated to have an IUPC during active labor	Device: Electrohysterography; The EHG uses a Graphium electrode patch that is applied to the abdomen and records electrical activity non-invasively; Other Names: PureTrace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy of uterine contraction sensing, comparing to invasive intrauterine catheter.	From insertion of IUPC untill its' removal ( due to vaginal delivery or referral to instrumental/ caesarean delivery).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final delivery mode	spontaneous, instrumental, caesarean	Third phase of delivery

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Aya Mohr Sasson, M.D, Sheba Medical Center

Publications and helpful links

Helpful Links

• article describing the benefit of the electrohysterography
• The company internet site

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: February 22, 2015
• First Submitted That Met QC Criteria: February 22, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: intrauterine pressure catheter; electrohysterography
• Other Study ID Numbers: 1980- 15-SMC