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

EchOpen Foundation0 个研究点目标入组 292 人开始时间: 2023年11月16日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•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.

•- 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.

发起方

EchOpen Foundation