Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage

Part of paid clinical trials in Denver, Colorado.

Sponsor
Baymatob Operations Pty Ltd
Study ID
NCT06655207
Status
Recruiting
Apply to this trial

Conditions

  • High Risk Pregnancy
  • Maternal Care Patterns
  • Post Partum Haemorrhage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding — DEVICE
    Oli is a non-invasive wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding, including postpartum haemorrhage.

Study Details

Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml (abnormal postpartum uterine bleeding) or cumulative blood loss of ≥1000ml (postpartum haemorrhage) at least 1 hour in advance of birth. This study is being undertaken to assess the performance of Oli measuring cumulative blood loss ≥500ml and ≥1000ml, as well as evaluate its safety profile.

Key Dates

Start date
Aug 6, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Primary Outcome Measure

Assess the performance of Oli as calculated by comparing the output of Oli (up to 1 hour prior to birth) against the clinically documented value of cumulative blood loss ≥ 500ml or any blood loss with signs and/or symptoms of hypovolemia within 24 hour [ Time Frame: 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UC Health University of Colorado HospitalDenverColorado80045
Jocelyn Phipers
[email protected]
3035794603
Katherine Kissler, Doctorate (PRINCIPAL_INVESTIGATOR)
Woman's HospitalBaton RougeLouisiana70817
Briasha Jones
[email protected]
225-428-7464
Elizabeth Sutton, Doctorate (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Sabine Bousleiman, Doctorate
[email protected]
212-305-2158
Casandra Almonte, Nursing
[email protected]
212-305-2158
Dena Goffman, Doctorate (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Devra Mast
[email protected]
614-685-4207
Kara Rood (PRINCIPAL_INVESTIGATOR)
UPMC Magee Womens HospitalPittsburghPennsylvania15213
Jeanette Boyce
[email protected]
412-641-4072
Sarah Roddick
[email protected]
412-641-4072
Hyagriv Simhan, Doctorate (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By research site
UC Health University of Colorado Hospital· Denver, COWoman's Hospital· Baton Rouge, LAColumbia University Irving Medical Center· New York, NYThe Ohio State University· Columbus, OHUPMC Magee Womens Hospital· Pittsburgh, PA

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