NCT07677670 AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
| NCT ID | NCT07677670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SOIK Corporation Sarl |
| Condition | Antenatal Care |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2026-06-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2026-06-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural Democratic Republic of the Congo. Primary outcomes are gestational age mean absolute error (Trimester 2 and Trimester 3) with 95% confidence intervals and AI confidence calibration. The reference standard is manual measurement by a reference reader (early ultrasound first; manual BPD if unavailable; last menstrual period is not used). Target enrollment is approximately 1,430 (IRB-approved ceiling 3,000), with early termination permitted upon achievement of pre-specified analysis-plan thresholds. The study is a multi-center prospective Hybrid Type 1 Effectiveness-Implementation design and includes a pre-specified adaptive model-update (Batch 2 cut) plan following FDA PCCP and STARD-AI guidance.
Eligibility Criteria
Inclusion Criteria: * Pregnant women * Identified at a participating facility routine ANC visit or RECO village outreach within the Kenge health zone catchment * Informed consent obtained (16-17 years with parent/guardian consent) Exclusion Criteria: * Emergency presentation * Multiple pregnancy * Duplicate re-registration of an already-enrolled woman * Lacking capacity to consent * Planned relocation outside Kwango province during the study period * Refusal of consent
Contact & Investigator
Kuniyuki Furuta
PRINCIPAL INVESTIGATOR
SOIK Corporation
Frequently Asked Questions
Who can join the NCT07677670 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying Antenatal Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07677670 currently recruiting?
Yes, NCT07677670 is actively recruiting participants. Contact the research team at furuta@soik.co.jp for enrollment information.
Where is the NCT07677670 trial being conducted?
This trial is being conducted at Kenge, Democratic Republic of the Congo.
Who is sponsoring the NCT07677670 clinical trial?
NCT07677670 is sponsored by SOIK Corporation Sarl. The principal investigator is Kuniyuki Furuta at SOIK Corporation. The trial plans to enroll 3,000 participants.