NCT06385366

Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test

Developing and Evaluating Models for Early Prediction of Obstetrical Diseases: Preeclampsia, Spontaneous Preterm Birth, and Gestational Diabetes in The Pregnant Women Performed Non-invasive Prenatal Screening (NIPT)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,105 (estimated)
• Sponsor: Gene Solutions · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam.

Detailed description

This study is estimated to enroll 663 pregnant women with adverse pregnancy complications, including 221 cases of PE/eclampsia, 221 cases of SPB due to Preterm premature rupture of membranes (PPROM) or preterm labor, and 221 cases of GDM. Furthermore, the control group will enroll 442 participants, who are healthy pregnancies, ≥ 37 weeks of gestation. Study subjects who participate should meet the study inclusion and exclusion criteria: As part of the protocol, demographic data, medical and family history, outcomes at delivery, and any relevant prior concomitant medication data will be recorded during follow-up visits. All participants are to be followed until birth delivery. SAMPLE COLLECTION * At recruitment, 10 mL of peripheral blood is collected for cffDNA and cfRNA analyses. * An available NIPT sample at 1st trimester is processed for cffDNA and cfRNA analyses. * A case report forms (CRF-1 and CRF-2) are used to collect demographic data, medical and family history, any relevant prior concomitant medication data, and outcomes at delivery. The study end date of a participant is estimated within 7 months since her enrollment date.

Conditions

• Pregnant With Complication
• Preeclampsia
• Preterm Birth
• Gestational Diabetes

Timeline

• Start date: 2024-05-10
• Primary completion: 2025-11-06
• Completion: 2025-11-06
• First posted: 2024-04-26
• Last updated: 2025-07-16

Locations

1 site across 1 country: Vietnam