Evaluation of a Novel Signal Acquisition Technique for Intrapartum Cardiotocography

NCT03268486 | Unknown

• 1 other identifier: ULisbon TAECG
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Labor Fetal Anoxia; Fetal Monitoring

Keywords

Fetal monitoring; cardiotocography

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Triple monitoring

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women (pregnant)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All pregnant women in labour at Hospital de Santa Maria, Lisbon

You may qualify if:

• 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. Patients with risk factors for intrapartum hypoxia will also be included.

You may not qualify if:

• Do not give a written consent.

Sponsors & Collaborators

• University of Lisbon: lead

Central Study Contacts

Catarina Carvalho, Resident

CONTACT

+351919297913; catarinareiscarvalho@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: October 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 31, 2019
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share