Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT06655207 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • 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

Study Locations (7)

New South Wales

  • Royal Hospital for Women — Randwick
  • Royal North Shore Hospital — St Leonards

Colorado

  • UC Health University of Colorado Hospital — Denver

Louisiana

  • Woman's Hospital — Baton Rouge

New York

  • Columbia University Irving Medical Center — New York

Ohio

  • The Ohio State University — Columbus

Pennsylvania

  • UPMC Magee Womens Hospital — Pittsburgh

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2025-08-06
Est. Completion 2026-07-30
Phase NA

Sponsor

Baymatob Operations Pty

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06655207

The ClinicalTrials.gov registry entry for NCT06655207 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baymatob Operations Pty, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with High Risk Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which 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 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06655207 reports 7 study locations spanning 6 distinct geographic areas — top geographies include New South Wales, Colorado, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06655207 about?

NCT06655207 is a clinical study titled "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". 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 (p...

What is the current status of trial NCT06655207?

This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2025-08-06. Estimated completion is 2026-07-30.

What conditions does trial NCT06655207 study?

This clinical trial studies the following conditions: High Risk Pregnancy, Maternal Care Patterns, Post Partum Haemorrhage. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06655207?

The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06655207?

This trial is sponsored by Baymatob Operations Pty, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06655207 being conducted?

This trial has 7 study locations across Colorado, Louisiana, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial