Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02374151 |
| Other study ID # |
1980- 15-SMC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2016 |
| Est. completion date |
July 2018 |
Study information
| Verified date |
July 2018 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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
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
