NCT03432767|Completed
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Sponsor study identifier
observational
67
1 country
1
Study Start
February 16, 2016
Actual (reported)Primary Completion
January 10, 2019
Actual (reported)Study Completion
January 11, 2019
Actual (reported)Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity, and is most commonly caused by poor uterine tone after delivery of the baby and placenta. Currently, a lack of early identification of PPH also results in delayed treatment, with an increase in morbidity. The investigators propose that 2 non-invasive methods may provide monitoring for early and accurate detection of PPH. These methods include shock index (SI) and continuous hemoglobin (Hb) monitoring. SI is defined as heart rate divided by systolic blood pressure, and can be used as a marker to predict the severity of hypovolemic shock. Continuous Hb monitoring can now be done using a non-invasive probe that is placed on the patient's finger. It provides real-time Hb values, rather than having to draw blood and wait for a lab test. The investigators hypothesize that SI will have a stronger association with postpartum blood loss than Hb variation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 11, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 16, 2016
Actual (reported)February 5, 2018
Actual (reported)February 14, 2018
Actual (reported)January 10, 2019
Actual (reported)January 11, 2019
Actual (reported)Shock index values
Calculated shock index (heart rate/systolic blood pressure) every 10 minutes from delivery until 2 hours postpartum.
2 hours
Hemoglobin values
Spectrophotometric hemoglobin values from a non-invasive monitor, recorded every 10 minutes from delivery until 2 hours postpartum.
2 hours
Estimated blood loss (calculated)
24 hours
Estimated blood loss (weight)
2 hours
Administration of uterotonic medication
24 hours
Blood transfusion
24 hours
Surgical interventions
24 hours
A non-invasive hemoglobin monitor will be attached to the patient's finger and kept on for 2 hours after she delivers. Heart rate and blood pressure will be measured every 10 minutes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women having an expected vaginal delivery
Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
Mrinalini Balki, MD
MOUNT SINAI HOSPITAL
67 participants (actual enrollment reported by the registry).
First Submitted
February 5, 2018
First Posted
February 14, 2018
Study Start
February 16, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 10, 2019
Actual (reported)Study Completion
January 11, 2019
Actual (reported)Last Updated
April 16, 2019
Record last verified: 2019-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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