Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT05054504
Eligibility Criteria:
Eligibility criteria by phase and participant type
Phase 1 Inclusion Criteria
1. Member of HC or hospital staff providing obstetric care.
2. Able and willing to comply with all study requirements and complete all study procedures.
3. Able and willing to provide informed consent to be screened for and to take part in the study.
Phase 1 Exclusion Criteria 1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Phase 2 Inclusion Criteria
Study Participant - Health Center and Hospital Staff:
1. Member of HC or hospital staff providing obstetric care.
2. Able and willing to comply with all study requirements and complete all study procedures.
3. Able and willing to provide informed consent to be screened for and to take part in the study.
Study Participant - ANC Clients:
Participants must meet all criteria to be eligible for inclusion in the study:
1. Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs).
2. At enrollment, present for first ANC visit.
3. Able and willing to comply with all study requirements and complete all Phase 2 study procedures.
4. Able and willing to provide informed consent to be screened for and to take part in Phase 2 of the study.
5. Intention to stay within study catchment area for study Phase 2 duration and willingness to give adequate locator information, as defined in site SOPs.
Phase 2 Exclusion Criteria
Study Participant - Health Center and Hospital Staff:
1\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Study participant - ANC Clients:
1\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Phase 3 Inclusion Criteria
1. Participated in Phase 1 or 2 of the study or newly recruited stakeholder interested in development or implementation of obstetric ultrasound in Malawi.
2. Able and willing to comply with all study requirements and complete all Phase 3 study procedures.
3. Able and willing to provide informed consent to be screened for and to take part in Phase 3 of the study.
Phase 3 Exclusion Criteria
1\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05054504
Study Brief:
Protocol Section:
NCT05054504