- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159105
Abdominal Ultrasound Assessment in the Post-cesarean Patient
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant
- 18 years of age or older
- English-speaking
- Non-urgent cesarean sections
Exclusion Criteria:
- Preeclampsia/eclampsia
- <18 years old
- Urgent/emergent cesarean section
- Not English-speaking
- Unable to consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women undergoing cesarean delivery
FAST scan and non-invasive hemoglobin measurement Women undergoing cesarean delivery will undergo a non-invasive hemoglobin measurement both before and after surgery. An abdominal ultrasound will be performed to establish normal levels of intra-abdominal fluid after cesarean delivery. |
A "FAST scan", or abdominal ultrasound will be performed within one hour of cesarean delivery to establish normal levels of postoperative intraabdominal fluid. Women will also have their hemoglobin measured via a non-invasive method, the Masimo Pronto 7, at 3 time points: immediately prior to surgery (within 2 hours), immediately after surgery (within 1 hour), and the morning following surgery (within 24 hours).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FAST Scan results
Time Frame: 1 hour
|
Abdominal ultrasound will be performed within 1 hour of surgery completion.
Studies will be classified as positive or negative, and the amount and location of intra-abdominal fluid will also be documented.
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1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-invasive hemoglobin measurement
Time Frame: 1 day
|
Non-invasive hemoglobin measurements will be taken immediately prior to surgery (baseline measurement), immediately postoperatively, and on the morning of postoperative day 1 (within 24 hours of surgery).
The results of the final measurement will be compared to the standard blood draw on postoperative day one of a routine complete blood count (CBC) to assess the accuracy of this non-invasive measurement technique among postpartum women.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dana R Gossett, MD, MSCI, Northwestern University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pregnancy Complications
- Obstetric Labor Complications
- Puerperal Disorders
- Uterine Hemorrhage
- Hemorrhage
- Postpartum Hemorrhage
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Chrysarobin
Other Study ID Numbers
- STU00080804
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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