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

Launched by BAYMATOB OPERATIONS PTY LTD · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a device called Oli, which is designed to help doctors identify patients who are at higher risk of experiencing significant bleeding after childbirth, a condition known as postpartum hemorrhage. The device is placed on the mother's belly during labor and can alert healthcare professionals if it detects that the mother may lose a large amount of blood (500 ml or more) before the baby is born. This early warning could help doctors take necessary precautions to ensure the mother's safety.

To participate in this study, women must be at least 18 years old, be at least 28 weeks pregnant, and planning to have a normal vaginal delivery (although emergency cesarean deliveries are allowed). Participants will be asked to sign a consent form to confirm they understand the study. The trial is currently not recruiting participants, so it’s still in the early stages. If eligible, participants can expect to wear the device during labor and help researchers learn more about its safety and effectiveness. It's important to note that certain conditions, like skin allergies to the materials used in the device, may prevent someone from participating.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • \>18 years of age
• • Provision of informed consent i.e. participant must be able to understand and sign the Participant Information and Consent Form
• • ≥28 weeks gestation
• • Planning for normal vaginal delivery (participants requiring emergency caesarean delivery will not be excluded)
• Exclusion Criteria:
• • Currently participating in an investigational study that in the Investigator's opinion makes it undesirable to participate in this trial.
• • Known significant sensitive skin or allergy/hypersensitivity to the medical gel/adhesive used to adhere the electrodes to the body
• • 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.
• • Participant was monitored in the intrapartum period in the Oli Pilot Study (ETH00410).