perinatal complications, interventions and outcome complications of the child before and during delivery, condition of the child after birth
Conditions
Interventions
Eligible patients who are monitored with FSE will be included for additional registration with NFMS. NFMS uses a
transabdominal, non-invasive electrode patch. This patch will be placed from the moment
Sponsors
Catharina Ziekenhuis
Eligibility
Inclusion criteria
Inclusion criteria: -Pregnant women who are in active labour -Pregnant women carrying a healthy, singleton fetus in cephalic presentation -Gestational age between 34 and 42 weeks.
Exclusion criteria
Exclusion criteria: -Maternal age below 18 years -Multiple pregnancy -Signs of fetal distress at the time of inclusion (abnormal NI-CTG requiring immediate intervention, maternal positive hepatitis B/C or HIV serology idiopathic thrombocytopenia or other fetal, maternal conditions which are a contraindication to FSE, contraindications to abdominal patch placement e.g. dermatologic diseases of the abdomen precluding preparation ofthe abdomen with abrasive paper) -Women connected to external or implanted electrical stimulators -Women with language barrier and mental disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: As a first primary endpoint, success rate, accuracy, and reliability of FHR monitored by NFMS will be compared with FHR monitored by gold standard FSE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: success rate, accuracy, and reliability of MHR monitored by NFMS will be compared with MHR monitored by standard care such as Doppler pulse measurements provided by abdominal pulse oximetry, incorporated in the TOCO button, or finger pulse oximetry. The UA monitored by NFMS will be compared with the one monitored by standard care such as tocodynamometer (TOCO) or intrauterine pressure catheter (IUPC). | — |
Countries
Germany, Netherlands
Contacts
Public ContactM.E.M.H. Westerhuis
Catharina Ziekenhuis
Outcome results
None listed