NCT06385366Enrolling by invitation
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)
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1105 (estimated)
- First submitted
- 22 Apr 2024
- Start date
- 10 May 2024
- Primary completion date
- 6 Nov 2025
- Lead sponsor
- Gene Solutions
- NCT number
- NCT06385366
What you commit to
- Study type: Observational
- Planned participants: 1105
- From 10 May 2024 to the primary completion date, 6 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Maternal medical history of diabetes mellitus type 1/ type 2, chronic hypertension, and chronic kidney disease. Maternal abnormal uterus anatomy and history of cervical cone biopsy sample or loop electrocautery excision procedures (LEEP).
Other
- Multiple pregnancies
- Pregnancy with any genetic abnormality
- Pregnancy with any fetal structural abnormality
- Pregnancy with indications for termination, miscarriage, or stillbirth due to other complications
Who the study is looking for
- At recruitment, women with singleton pregnancies must fulfill the conditions:
- Cases: diagnosis of Preeclampsia/eclampsia, Preterm premature rupture of membranes (PPROM)/preterm labor leading to SPB, and/or gestational diabetes mellitus.
- Controls: healthy pregnancy at ≥ 37 weeks of gestation
- History of undergoing non-invasive prenatal testing (NIPT) at 9-13 weeks 6 days of gestation at Gene Solutions Lab. NIPT report was at low-risk. No abnormal fetal and maternal conditions were confirmed at NIPT time.
- NIPT blood sample is available according to post-test sample storage procedures at Gene Solutions Lab.
- Consent to voluntarily participate in the study
Age in the registry: 18 years to 80 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Genetics Institute Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.