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NCT06655207 · ClinicalTrials.gov registry record · 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

A NA study of High Risk Pregnancy and Maternal Care Patterns, sponsored by Baymatob Operations Pty.

Recruiting
Registry status
NA
Development phase
1,000
Enrollment target
7
Study locations

NCT06655207 is a NA study of High Risk Pregnancy and Maternal Care Patterns that is actively recruiting participants, run by Baymatob Operations Pty. The registered enrollment target is 1,000 participants, above the 228-participant average among 10 other High Risk Pregnancy trials with a reported enrollment target (339% higher). The trial reports 7 study locations across 6 states.

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The verdict

NCT06655207, a NA study of High Risk Pregnancy and Maternal Care Patterns, is actively recruiting participants, sponsored by Baymatob Operations Pty.

RECRUITING
Registry status
NA
Development phase
1,000 participants
Enrollment target
7
Study locations

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

What the Registry Record Tells You About NCT06655207

The ClinicalTrials.gov registry entry for NCT06655207 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 228-participant average among 10 other High Risk Pregnancy trials with a reported enrollment target (339% higher). The listed sponsor is Baymatob Operations Pty, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT06655207 reports 7 study locations spanning 6 distinct geographic areas - top geographies include New South Wales, Colorado, Louisiana.

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.

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).

Who is sponsoring clinical trial NCT06655207?

This trial is sponsored by Baymatob Operations Pty, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

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

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