An interventional study of point-of-care ultrasound in Abdominal Pain and Pelvic Pain, sponsored by Lifespan. Completed at 1 site in United States. Open to female participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Lifespan · Not applicable, Interventional, and Other
Among 158 studies in Abdominal Pain with a site in United States — 23 open to participants now, 24 under way, 1 of them phase 3. Abdominal Pain · United States.
Among the 158 studies in Abdominal Pain with a site in United States, this one is the 45th largest by enrollment of the 133 interventional ones that give a count, is one of 6 that started in 2015, is one of 74 with no phase, and was the 88th registered.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
Browse Abdominal Pain studies →23 of the 158 studies in Abdominal Pain with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 6–17
Baylor College of Medicine · Sites in United States
Ages 7–12
Case Comprehensive Cancer Center · Sites in United States
Ages 18+
Kiwi Health Inc · Sites in United States
Ages 18+ · Healthy volunteers
Ohio State University · Sites in United States
Ages 18–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Abdominal Pain studies recruiting now, 13 (39%) set no upper age limit and 17 (52%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.
This study: 8 Years to 18 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
158 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 31 · Phase 3 15 · Phase 4 11
First in 1996; this study’s year is marked. 6 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 120 is above the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Median enrollment 61 across the 133 interventional studies, 94 across the 24 observational. Of the 119 that completed or were terminated, 38 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
40 of 158 have an industry lead sponsor. The 10 most frequent:
Lifespan is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Lifespan has 1 study filed under Abdominal Pain — fewer than ten, so there is no comparison to draw.
10 of the studies in Abdominal Pain with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07174609Johns Hopkins UniversityScrambler Therapy in Chronic Pancreatitis | 2026-12-01 |
| NCT07649720AnX Robotica Corp.NaviCam Patency Capsule to Verify Gastrointestinal Patency | 2026-12-15 |
| NCT06647615Mayo ClinicA Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease | 2026-12-31 |
| NCT07117032Case Comprehensive Cancer CenterSimulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain | 2027-02 |
| NCT06706778Yale UniversityThe Mechanism Underlying the Analgesic Effect of the Music of IBS Pain | 2027-03 |
Add all 10 to your calendar (.ics) → With an account.
Among the 158 studies in Abdominal Pain with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the accuracy and utility of point-of-care ultrasound (POCUS) of the bladder compared to patient's sensation of bladder fullness in predicting the ability to successfully perform a comprehensive transabdominal pelvic ultrasound in the pediatric Emergency Department (ED). We hypothesize that POCUS can more accurately and more quickly determine adequate bladder fullness to successfully perform transabdominal pelvic ultrasound than patient's perception of bladder fullness.
Ultrasound (US) is the preferred imaging modality in the pediatric ED in the diagnostic evaluation of girls with suspected pelvic pathology. In the transabdominal approach, urine acts as a sonographic acoustic window to image the adnexa and uterus, but this requires a full bladder. Many high acuity pelvic pathologies presenting to the pediatric ED have significant morbidity and mortality associated with delays in diagnosis. Despite this, diagnostic pelvic US is often delayed by the need to fill the bladder, awaiting a patient's report of subjective sensation of bladder fullness. Images of the bladder using POCUS can be easily obtained at the bedside by emergency physicians, providing a quick assessment of the size and shape of the bladder that may be a more accurate, objective measure of bladder fullness. We aim to assess the utility of POCUS of the bladder compared to patient's sensation of bladder fullness in this clinical scenario.
This is a pragmatic, randomized controlled trial of a convenience sample of girls being treated in a pediatric ED who present with an indication for transabdominal pelvic US. Patients will be randomized to two groups:
Patients in both groups will be assessed at 30-minute intervals for sensation of bladder fullness on a 0-4 Likert Scale, total volume of IVF given per kilogram, and POCUS of the bladder. Overall time between initial ordering of transabdominal pelvic US (Time 0) to the time the patient went for successful US will be recorded and compared between the two groups. Success rate of first attempt at transabdominal pelvic US will also be recorded and compared between the two groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be given consecutive IV fluid boluses until a full bladder is visualized by the ED physician on POCUS or the patient endorses maximal bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician.
Other: point-of-care ultrasound
Patients will be given consecutive IV fluid boluses until the patient endorses sensation of maximum bladder fullness on a 0-4 Likert Scale. The patient will then have a transabdominal pelvic ultrasound performed by a radiologist or ultrasound technician
Median Fill-To-Done (FTD) Time
Median time from enrollment to successful completion of TAPUS
Time frame: on same day as study enrollment
Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt
Time frame: on same day as study enrollment
Number of Participants Receiving IV Narcotics in the Emergency Department
Time frame: day of enrollment
Total IV Fluids Given Prior to TAPUS
Time frame: day of enrollment
TAPUS Result
Time frame: day of enrollment
Disposition From ED
Time frame: day of enrollment
Inter-rater Agreement
Agreement between the POCUS sonographer and the blinded reviewer
Time frame: at close of study
| Milestone | Point-of-care Ultrasound (POCUS) | Usual Care (UC) |
|---|---|---|
| Started | 60 | 60 |
| Completed | 58 | 59 |
| Not completed | 2 | 1 |
| Withdrew: Ultrasound order was cancelled | 2 | 1 |
Median time from enrollment to successful completion of TAPUS
| minutes | POCUS | Usual Care |
|---|---|---|
| Median Fill-To-Done (FTD) Time | 87.5 (67 to 126) | 139 (92 to 193) |
| Participants | POCUS | Usual Care |
|---|---|---|
| Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt | 58 | 50 |
| Participants | POCUS | Usual Care |
|---|---|---|
| Number of Participants Receiving IV Narcotics in the Emergency Department | 21 | 26 |
| ml/Kg | POCUS | Usual Care |
|---|---|---|
| Total IV Fluids Given Prior to TAPUS | 19.4 ± 15.1 | 22.9 ± 13.5 |
| Participants | POCUS | Usual Care |
|---|---|---|
| Normal | 46 | 48 |
| Abnormal | 12 | 11 |
| Ovarian torsion | 4 | 2 |
| Simple ovarian cyst | 1 | 3 |
| Ruptured/hemorrhagic cyst | 5 | 5 |
| Other ovarian abnormality | 2 | 0 |
| Uterine anomaly | 0 | 1 |
| Pathologic free fluid | 1 | 2 |
| Hydrosalpinx | 1 | 0 |
| Participants | POCUS | Usual Care |
|---|---|---|
| Discharged home | 43 | 44 |
| Admit to ward | 11 | 11 |
| Admitted to operating room | 5 | 5 |
| Transferred | 1 | 0 |
Agreement between the POCUS sonographer and the blinded reviewer
| weighted kappa | Bladder POCUS Images |
|---|---|
| Inter-rater Agreement | 0.83 (0.79 to 0.87) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| POCUS | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Usual Care | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | POCUS | Usual Care | Total |
|---|---|---|---|
| Mean | 14.1 ± 2.43 | 14.7 ± 2.34 | 14.4 ± 2.39 |
| Sex: Female, Male(Participants) | POCUS | Usual Care | Total |
|---|---|---|---|
| Female | 60 | 60 | 120 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | POCUS | Usual Care | Total |
|---|---|---|---|
| Non-Hispanic White | 31 | 37 | 68 |
| Non-Hispanic Black | 5 | 5 | 10 |
| Hispanic | 22 | 14 | 36 |
| Other | 2 | 4 | 6 |
| Region of Enrollment(Participants) | POCUS | Usual Care | Total |
|---|---|---|---|
| United States | 60 | 60 | 120 |
| Body Mass Index (BMI)(kg/m2) | POCUS | Usual Care | Total |
|---|---|---|---|
| Mean | 23.0 ± 4.81 | 25.4 ± 6.57 | 24.2 ± 5.86 |
| Time since last void(minutes) | POCUS | Usual Care | Total |
|---|---|---|---|
| Median | 126.5 (65 to 189) | 120.5 (65 to 200) | 125 (65 to 190) |
| Time from TAPUS order by physician to study enrollment(minutes) | POCUS | Usual Care | Total |
|---|---|---|---|
| Median | 32.0 (21 to 49.5) | 34.5 (23.5 to 51) | 32.5 (21 to 49.3) |
| Chief Complaint(Participants) | POCUS | Usual Care | Total |
|---|---|---|---|
| Abdominal Pain | 56 | 50 | 106 |
| Vomiting | 3 | 3 | 6 |
| Dysuria/flank pain/hematuria | 5 | 5 | 10 |
| Other | 0 | 3 | 3 |
Plan to share: No
The record gives a start of Sep 2015, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2017, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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