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Clinical Trials/PACTR202311722468070
PACTR202311722468070
Not yet recruiting
未知

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

EchOpen Foundation0 sites292 target enrollmentNovember 16, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Pregnancy and Childbirth
Sponsor
EchOpen Foundation
Enrollment
292
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 16, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
EchOpen Foundation

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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