ParturitionNCT02408588
Evaluation of Compensatory Reserve in Obstetrical Patients
An observational study of Parturition and Fetal Intervention, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 44 years, women only
- Conditions the study is for
- Parturition, Fetal Intervention
- What is being tested?
- Pulse oximeter
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Enrollment is limited to pregnant females because only pregnant females undergo fetal surgery and/or labor and childbirth.
Who may be able to join
- 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)
Who cannot join
- Incarcerated
- Decisionally challenged
- Patients who object at any time to participating in the study
About this study
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.
Read the detailed description
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:
- Determine how regional anesthesia influences CRI algorithm calculations
- Determine if the CRI algorithm is able to detect changes in central volume status associated with fetal surgery.
- Determine if the CRI algorithm is able to detect changes in central volume status associated with labor and childbirth specifically at the time of delivery, when most women experience some amount of bleeding.
- Examine CRI associated with induction of regional anesthesia and determine if there is a minimal CRI below which one can expect hypotension and if there is a trend down in CRI following induction of regional anesthesia that could anticipate/predict hypotension.
- Determine if there is a correlation between fetal heart rate abnormalities and CRI.
- Examine CRI associated with fetal monitoring.
- Conditions
- Parturition, Fetal Intervention
- Being tested
- Pulse oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterOther
Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
| Study group | Role | What they receive |
|---|---|---|
| Childbirth and epidural | Pregnant women giving childbirth who receive an epidural. Receives: Other: Pulse oximeter | |
| Childbirth and general anesthesia | Pregnant women giving childbirth who receive general anesthesia Receives: Other: Pulse oximeter | |
| Fetal Intervention and epidural | Pregnant women receiving fetal intervention and an epidural Receives: Other: Pulse oximeter | |
| Fetal Intervention and general anesthesia | Pregnant women receiving fetal intervention and general anesthesia Receives: Other: Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Central Volume Status
Use pulse oximeter waveform data to determine central volume status changes
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study start1 Feb 2015
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Moulton, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408588
- Sponsor's protocol ID
- 14-1996
- Status last verified
- Sep 2023
- First submitted
- 31 Mar 2015
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Compensatory Reserve in Obstetrical Patients
- ClinicalTrials.gov ID
- NCT02408588
- Acronym / sponsor ID
- 14-1996
- Conditions
- Parturition, Fetal Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Determine how regional anesthesia influences CRI algorithm calculations
- Determine if the CRI algorithm is able to detect changes in central volume status associated with fetal surgery.
- Determine if the CRI algorithm is able to detect changes in central volume status associated with labor and childbirth specifically at the time of delivery, when most women experience some amount of bleeding.
- Examine CRI associated with induction of regional anesthesia and determine if there is a minimal CRI below which one can expect hypotension and if there is a trend down in CRI following induction of regional anesthesia that could anticipate/predict hypotension.
- Determine if there is a correlation between fetal heart rate abnormalities and CRI.
- Examine CRI associated with fetal monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Childbirth and epidural | – | Other: Pulse oximeterPregnant women giving childbirth who receive an epidural. |
| Childbirth and general anesthesia | – | Other: Pulse oximeterPregnant women giving childbirth who receive general anesthesia |
| Fetal Intervention and epidural | – | Other: Pulse oximeterPregnant women receiving fetal intervention and an epidural |
| Fetal Intervention and general anesthesia | – | Other: Pulse oximeterPregnant women receiving fetal intervention and general anesthesia |
Who may qualify
- Ages
- 0 days to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Enrollment is limited to pregnant females because only pregnant females undergo fetal surgery and/or labor and childbirth.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Incarcerated
- Decisionally challenged
- Patients who object at any time to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeterPlace a pulse oximeter on the subject which will record the pulse oximeter waveform. | Other | Childbirth and epidural, Childbirth and general anesthesia, Fetal Intervention and epidural, Fetal Intervention and general anesthesia |
Primary outcome
Changes in Central Volume Status
Time frame: enrollment
Use pulse oximeter waveform data to determine central volume status changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Related trials for Parturition
Not yet recruitingObservational study
The Experience of Fathers and Mothers in Relation to the Presence of the Father at the Birth in the Case of a Planned Caesarean Section: a Qualitative Phenomenological Study
Cesarean Section, Parturition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Moulton, MD principal investigator
Children's Hospital Colorado
Questions about this trial
What is this clinical trial studying?
An observational study of Parturition and Fetal Intervention, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Central Volume Status (time frame: enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.