RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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, in Advance of Delivery/Birth

Quick Facts

Study Start:2025-08-06
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06655207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18 years of age
  2. * Provision of informed consent i.e. participant must be able to understand and sign the Participant Information and Consent Form
  3. * ≥28 weeks gestation
  4. * Planning for normal vaginal delivery (participants requiring emergency caesarean delivery will not be excluded)
  1. * Currently participating in an investigational study that in the Investigator's opinion makes it undesirable to participate in this trial.
  2. * Known significant sensitive skin or allergy/hypersensitivity to the medical gel/adhesive used to adhere the electrodes to the body
  3. * Any concurrent condition which in the Investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol or follow up.
  4. * Participant was monitored in the intrapartum period in the Oli Pilot Study (ETH00410).

Contacts and Locations

Study Contact

Bernadette Pickering
CONTACT
+61 (2) 9871 7412
bernadette.pickering@baymatob.com

Study Locations (Sites)

UC Health University of Colorado Hospital
Denver, Colorado, 80045
United States
Woman's Hospital
Baton Rouge, Louisiana, 70817
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
The Ohio State University
Columbus, Ohio, 43210
United States
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Baymatob Operations Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-06
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2025-08-06
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • Pivotal Study
  • Single arm
  • prospective

Additional Relevant MeSH Terms

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