NCT03268486|Unknown
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Sponsor study identifier
observational
50
0 countries
N/A
Study Start
October 1, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cardiotocography (CTG) is widely used during labour wards in industrialised countries and consists of fetal heart rate and uterine contraction monitoring. The main aim is to identify fetuses that are being poorly oxygenated during labour and require medical intervention to revert the situation or expedite delivery. The need for technical development of CTG is well-recognized, as some of the existing techniques are prone to signal loss and contamination from the maternal heart rate, while others are invasive and have established contra-indications. They also limit maternal mobilisation, contributing to maternal dissatisfaction, and possibly to adverse maternal and neonatal outcomes. New techniques for CTG acquisition will shortly be made available by a leading technological company, providing non-invasive monitoring and allowing full maternal mobilisation, and with the potential to change the way labour is conducted in high-resource countries. There is a need for a systematic evaluation of their clinical performance and benefit.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 29, 2017
Actual (reported)August 31, 2017
Actual (reported)October 1, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Signal quality
Transabdominal ECG and Doppler will be compared in terms of signal loss, and with internal ECG regarding signal accuracy. The signal quality will be analysed separately for each monitoring method for the time during which the FHR recorded.
The analysis will be made at the end of the recruiting phase (that will have 3 months of duration)
Pregnant women with singleton term pregnancies, spontaneous or induced/augmented labor, cephalic presentation, \> 18 years of age, able to provide written informed consent, no contraindications to internal FHR monitoring and no known contraindication to vaginal delivery. After giving written informed consent, women will be simultaneously monitored with scalp electrode, Doppler, trans-abdominal ECG, abdominal EHG and TOCO, as soon as internal monitoring is possible.
All pregnant women in labour at Hospital de Santa Maria, Lisbon
First Submitted
August 29, 2017
First Posted
August 31, 2017
Study Start
October 1, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2018
Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 31, 2017
Record last verified: 2017-08
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