By InvitationNot Applicable

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

Vietnam1,105 participantsStarted 2024-05-10

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At recruitment, women with singleton pregnancies must fulfill the conditions:
✓. 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

Exclusion criteria

✕. 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
✕. 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).

What they're measuring

Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation)

Timeframe: 12 months

Characteristics of pregnant women at recruitment

Timeframe: 12 months

Define the significant differences between cases and controls

Timeframe: 12 months

The development of learning machine models

Timeframe: 12 months

Evaluation of the developed models

Timeframe: 12 months

Trial details

NCT IDNCT06385366

SponsorGene Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11-06

View on ClinicalTrials.gov More Pregnant With Complication trials

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At recruitment, women with singleton pregnancies must fulfill the conditions:
✓. 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

Exclusion criteria

✕. 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
✕. 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).

What they're measuring

Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation)

Timeframe: 12 months

Characteristics of pregnant women at recruitment

Timeframe: 12 months

Define the significant differences between cases and controls

Timeframe: 12 months

The development of learning machine models

Timeframe: 12 months

Evaluation of the developed models

Timeframe: 12 months