Feasibility And Acceptability Of Integrating The EchOpen O1 Device In Pregnancy Monitoring In Three Maternity Hospitals In Beni

Not Applicable

• Conditions: Pregnancy and Childbirth

• Registration Number: PACTR202311722468070
• Lead Sponsor: EchOpen Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-16
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 292

Inclusion Criteria

In the first phase of the study (the first three months):
All pregnant women attending antenatal clinics in one of the three study pilot maternity units, aged at least 18, with a pregnancy of at least 37 weeks' amenorrhoea (SA), who had given their informed consent to receive free exploration with the echOpen O1 probe and any other stakeholder from one of the study sites who had given their written informed consent to participate in the sociological study.
- In the second phase of the study (last three months):
All pregnant women attending antenatal clinics in one of the three study pilot maternity units, aged at least 18 years, with a pregnancy of at least 29 SA, who had given their informed consent to receive free exploration with the echOpen O1 probe and any other stakeholder from one of the study sites who had given their written informed consent to participate in the sociological study.

Exclusion Criteria

- Pregnant women (or pregnant women) with a pregnancy complication or comorbidity, or who have not given informed consent to participate in the study,
- Pregnant women in labour,
- Midwives practising solely in the delivery room (case of the CHU-MEL) or who had not given their written consent to participate in the sociological study,
- Other stakeholders from one of the study sites who did not give written informed consent to participate in the sociological study.
- Significant clinical evidence (in the opinion of the investigator) of a health problem or abnormality likely to compromise the safety or interpretation of the efficacy of the clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified