Evaluation of Compensatory Reserve in Obstetrical Patients

NCT02408588 | Unknown

• 1 other identifier: 14-1996
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parturition; Fetal Intervention

Outcome Measures

Primary Outcomes (1)

• Changes in Central Volume Status

  Use pulse oximeter waveform data to determine central volume status changes

  enrollment

Study Arms (4)

Childbirth and epidural

Pregnant women giving childbirth who receive an epidural.

Other: Pulse oximeter

Childbirth and general anesthesia

Pregnant women giving childbirth who receive general anesthesia

Other: Pulse oximeter

Fetal Intervention and epidural

Pregnant women receiving fetal intervention and an epidural

Other: Pulse oximeter

Fetal Intervention and general anesthesia

Pregnant women receiving fetal intervention and general anesthesia

Other: Pulse oximeter

Interventions

Pulse oximeter OTHER

Place a pulse oximeter on the subject which will record the pulse oximeter waveform.

Childbirth and epidural; Childbirth and general anesthesia; Fetal Intervention and epidural; Fetal Intervention and general anesthesia

Eligibility Criteria

• Age: 0 Days - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Enrollment is limited to pregnant females because only pregnant females undergo fetal surgery and/or labor and childbirth.

You may qualify if:

• Age: 14 years - 44 years or 0 day old neonates born during the protocol
• Pregnant
• Patients undergoing regional anesthesia and either fetal intervention surgery or labor at Children's Hospital Colorado (CHCO) or University of Colorado Hospital (UCH)

You may not qualify if:

• Incarcerated
• Decisionally challenged
• Patients who object at any time to participating in the study

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Officials

• Steven Moulton, MD

  Childrens Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09