Postpartum HemorrhageNCT02159105
Abdominal Ultrasound Assessment in the Post-cesarean Patient
An observational study of Postpartum Hemorrhage and Postsurgical Bleeding, run by Northwestern University at 1 site in United States.
Trial summary
This study is designed to see if abdominal ultrasound after planned cesarean delivery can identify women with ongoing intra-abdominal bleeding. Read more about this study
- Who is it for?
- Ages 12 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Postsurgical Bleeding, Abdominal Ultrasound
- What is being tested?
- FAST scan and non-invasive hemoglobin measurement
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- 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 12 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women undergoing non-emergent cesarean delivery at Prentice Women's Hospital, who speak English and are able to provide consent, will be eligible to participate.
Who may be able to join
- Pregnant
- 18 years of age or older
- English-speaking
- Non-urgent cesarean sections
Who cannot join
- Preeclampsia/eclampsia
- <18 years old
- Urgent/emergent cesarean section
- Not English-speaking
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to see if abdominal ultrasound after planned cesarean delivery can identify women with ongoing intra-abdominal bleeding.
Read the 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
- Being tested
- FAST scan and non-invasive hemoglobin measurement
- Keywords
- postpartum hemorrhage, postsurgical bleeding, abdominal ultrasound, FAST scan, non-invasive hemoglobin measurement
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST scan and non-invasive hemoglobin measurementDevice
Also called Masimo Pronto 7, FAST scan
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FAST scan and non-invasive hemoglobin measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAST Scan results
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.
Measured: 1 hour
Secondary outcomes (1)
Non-invasive hemoglobin measurement
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Gossett, Northwestern University
- Investigators
- Dana R Gossett, MD, MSCI, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159105
- Sponsor's protocol ID
- STU00080804
- Status last verified
- Jul 2016
- First submitted
- 5 Jun 2014
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26302357
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Ultrasound Assessment in the Post-cesarean Patient
- ClinicalTrials.gov ID
- NCT02159105
- Acronym / sponsor ID
- STU00080804
- Conditions
- Postpartum Hemorrhage, Postsurgical Bleeding, Abdominal Ultrasound, FAST Scan, Non-invasive Hemoglobin Measurement
- Keywords
- postpartum hemorrhage, postsurgical bleeding, abdominal ultrasound, FAST scan, non-invasive hemoglobin measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Jun 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing cesarean delivery | – | Device: FAST scan and non-invasive hemoglobin measurementFAST 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. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women undergoing non-emergent cesarean delivery at Prentice Women's Hospital, who speak English and are able to provide consent, will be eligible to participate.
Key inclusion criteria (4 listed)
- Pregnant
- 18 years of age or older
- English-speaking
- Non-urgent cesarean sections
Key exclusion criteria (5 listed)
- Preeclampsia/eclampsia
- <18 years old
- Urgent/emergent cesarean section
- Not English-speaking
- Unable to consent
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 |
|---|---|---|
| FAST scan and non-invasive hemoglobin measurementAlso: Masimo Pronto 7, FAST scanA "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). | Device | Women undergoing cesarean delivery |
Primary outcome
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.
1 secondary outcome
Non-invasive hemoglobin measurement
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Results publication: PubMed 26302357Hoppenot 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.
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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.
Dana R Gossett, MD, MSCI principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage and Postsurgical Bleeding, run by Northwestern University at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FAST Scan results (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159105, which also lists 1 linked publication.
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 20 Jul 2016.