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Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01497756
Enrollment
10
Registered
2011-12-22
Start date
2011-08-31
Completion date
2012-05-31
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Brief summary

A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any use of a CAPP device will be monitored to identify complications.

Detailed description

Providers will be surveyed twice at 4 and 8 months using open ended methods.

Interventions

DEVICECAPP use

Any abdominal pelvic pressure

Sponsors

University of New Mexico
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Any patient receiving CAPP during study period.

Exclusion criteria

* None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.

Design outcomes

Primary

MeasureTime frameDescription
UsageEight monthsNumber of patients on whom CAPP is used

Secondary

MeasureTime frameDescription
Side EffectsEight monthsAny recorded complications

Countries

United States

Participant flow

Participants by arm

ArmCount
CAPP Application
Patients in whom device is used
10
Total10

Baseline characteristics

CharacteristicCAPP Application
Age, Categorical
<=18 years
NA Participants
Age, Categorical
>=65 years
NA Participants
Age, Categorical
Between 18 and 65 years
NA Participants
Age, ContinuousNA years
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Usage

Number of patients on whom CAPP is used

Time frame: Eight months

Population: Entire number of participants

ArmMeasureValue (NUMBER)
CAPP ApplicationUsage10 participants
Secondary

Side Effects

Any recorded complications

Time frame: Eight months

Population: All patients

ArmMeasureValue (NUMBER)
CAPP ApplicationSide Effects0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026