Abdominal Ultrasound Assessment in the Post-cesarean Patient

NCT ID: NCT02159105

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-06-30

Brief Summary

This study is designed to see if abdominal ultrasound after planned cesarean delivery can identify women with ongoing intra-abdominal bleeding.

Detailed Description

Hemorrhage is the second leading cause of maternal mortality in the United States. Women have an increased risk of hemorrhage after cesarean sections.Uterine atony is the culprit in 80% of cases, but in the post-operative patient, an intra-abdominal bleed requiring a return to the operating room must also be considered. The Focused Assessment with Sonography in Trauma (FAST) has been used in the emergency department to evaluate for intra-abdominal bleeding after trauma. FAST evaluation has not been studied in the post-operative period for evaluation for intra-abdominal bleeding. Ultrasound is a rapid and readily-available modality for this type of evaluation, and obstetricians are already familiar with the technology. But one must be cautious, as a certain amount of free fluid on CT is common in the postoperative patient. Before basing clinical decisions on a FAST scan, we much determine how much fluid is normal in a patient after cesarean delivery. We hypothesize that a certain amount of fluid in the abdomen visualized by ultrasound may be normal after a cesarean delivery, and that for ultrasound to become a valuable modality to assess for intra-abdominal bleeding in the post-cesarean patient, the amount of normal fluid must be determined. However, in order to interpret what an "appropriate" amount of fluid would be, we will also need an assessment of patient hemoglobin levels. Thus, we would additionally plan to validate a rapid, non-invasive hemoglobin measurement for use in the post-cesarean obstetric patient. The Pronto7 device measures the blood's absorption of multiple wavelengths of light to determine hemoglobin. The device avoids a blood draw and its associated pain. It also provides immediate results. We anticipate that we will identify an association between the amount of fluid seen on ultrasonographic evaluation after cesarean delivery and adverse outcomes such as larger than expected decrease in hemoglobin, need for transfusion and need for take-back to the operating room. We also anticipate that the use of non-invasive hemoglobin measurements may provide a rapid, painless assessment of postoperative hemoglobin; this may allow us to identify patients who merit earlier postoperative monitoring with a traditional CBC. It may also allow us to identify women who do not need an invasive CBC on postoperative day 1, which may decrease blood draws and costs in the future.

Conditions

Postpartum Hemorrhage; Postsurgical Bleeding; Abdominal Ultrasound; FAST Scan; Non-invasive Hemoglobin Measurement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

FAST scan and non-invasive hemoglobin measurement

Intervention Type: DEVICE

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).

Interventions

FAST scan and non-invasive hemoglobin measurement

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).

Intervention Type: DEVICE

Other Intervention Names

Masimo Pronto 7; FAST scan

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Dana Gossett

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dana R Gossett, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

Hoppenot C, Tankou J, Stair S, Gossett DR. Sonographic evaluation for intra-abdominal hemorrhage after cesarean delivery. J Clin Ultrasound. 2016 May;44(4):240-4. doi: 10.1002/jcu.22289. Epub 2015 Aug 24.

Reference Type: RESULT

PMID: 26302357 (View on PubMed)

Other Identifiers

STU00080804

Identifier Type: -

Identifier Source: org_study_id