Ambulatory Fetal Heart Rate Monitoring in Small Babies

CompletedOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

November 8, 2016

Study Completion Date

November 11, 2016

Conditions
High Risk Pregnancy
Interventions
DEVICE

Fetal heart rate monitor (Monica AN24)

"The AN24 is a portable, battery powered device, developed in the UK and designed to monitor passively an unborn baby in the antenatal period. The device is CE marked and is attached via a cable assembly which in turn attaches to five standard disposable electrodes placed on the abdomen of a pregnant woman. It is intended for ambulatory use in either the home or hospital environment.~The AN24 has had rigorous checks in the UK and has been used in many European countries. No hazards have been identified that could compromise the safety of, or cause harm to the fetus or the mother. The only potential issue identified is a local reaction under the electrodes. Nonetheless, the electrodes used are the standard disposable ECG electrodes, used routinely for adult ECG measurements."

Trial Locations (1)

Unknown

Jessop Wing Hospital, Sheffield

All Listed Sponsors
lead

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

NCT02627482 - Ambulatory Fetal Heart Rate Monitoring in Small Babies | Biotech Hunter | Biotech Hunter