An observational study in Parturition and Fetal Intervention, sponsored by University of Colorado, Denver. Status unknown. Open to female participants aged 0 Days to 44 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by University of Colorado, Denver · Observational
Using a pulse oximeter, the investigators have developed an algorithm that assesses central volume status. Pregnant women present some unique opportunities for us to investigate the algorithm under different circumstances. The investigators want to specifically investigate an algorithm with women who undergo regional anesthesia such as epidurals, with women who undergo fetal surgery, and with women in labor and giving birth (and the recovery time following delivery). This will help the investigators understand the central volume status changes that women experience in these unique circumstances. The Investigators also want to put the pulse oximeter on the fetal hand when possible during certain maternal fetal interventions. The Investigators would like to examine the algorithm with data from the fetuses.
The Investigators hypothesize that the Compensatory Reserve Index (CRI) algorithm will help to guide fluid management in women undergoing regional anesthesia, giving birth, and/or undergoing maternal fetal intervention surgery.
Specific aims:
Collect noninvasive physiological waveform data from patients undergoing regional anesthesia and either fetal intervention surgery or labor and delivery at Children's Hospital Colorado in order to:
University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Enrollment is limited to pregnant females because only pregnant females undergo fetal surgery and/or labor and childbirth.
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Exclusion Criteria:
Pregnant women giving childbirth who receive an epidural.
Other: Pulse oximeter
Pregnant women giving childbirth who receive general anesthesia
Other: Pulse oximeter
Pregnant women receiving fetal intervention and an epidural
Other: Pulse oximeter
Pregnant women receiving fetal intervention and general anesthesia
Other: Pulse oximeter
Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
Changes in Central Volume Status
Use pulse oximeter waveform data to determine central volume status changes
Time frame: enrollment
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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