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

NCT06385366 | Enrolling By Invitation

• 1 other identifier: GS_NP1
• Study Type: observational
• Target: 1,105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnant With Complication; Preeclampsia; Preterm Birth; Gestational Diabetes

Keywords

cffDNA; cfRNA; Vietnam

Outcome Measures

Primary Outcomes (5)

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

  Observe the characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation): clinical features, cffDNA, cfRNA

  12 months

• Characteristics of pregnant women at recruitment

  Characteristics of pregnant women at recruitment: clinical features, cffDNA, cfRNA

  12 months

• Define the significant differences between cases and controls

  Comparison between clinical features, cffDNA, and cfRNA of early pregnancy and at recruitment, then defines the significant differences between cases and controls

  12 months

• The development of learning machine models

  The development of learning machine models involved potential factors that help predict events of interest (PE, SPB, and GDM). From cfRNA and cfDNA data, factors that differ between the two groups will be identified and evaluated for their potentiality in predicting high-risk individuals. The Receiver Operating Characteristic (ROC) curve and values of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were used to determine the validity of the constructed model.

  12 months

• Evaluation of the developed models

  Evaluation of the developed models by determining their sensitivity, specificity, area under the ROC Curve (AUC), positive predictive value (PPV), negative predictive value (NPV), and accuracy.

  12 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population will include women with singleton pregnancies, who are diagnosed Preeclampsia/eclampsia, Preterm premature rupture of membranes (PPROM)/preterm labor leading to SPB, and/or gestational diabetes mellitus or who are healthy pregnancy at ≥ 37 weeks of gestation.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gene Solutions: lead
• Medical Genetics Institute (MGI): collaborator

Study Sites (1)

Medical Genetics Institute

Ho Chi Minh City, Hồ Chí Minh, Vietnam

Location

Related Publications (19)

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Related Links

• Mastrolia SA, Cetin I. The "Great Obstetrical Syndromes". In: Petraglia F, Fauser BC, editors. Female Reproductive Dysfunction. Cham: Springer International Publishing; 2020. p. 411-30. Available from: https://doi.org/10.1007/978-3-030-14782-2\_21.

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Pregnancy Complications; Pre-Eclampsia; Premature Birth; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Obstetric Labor, Premature; Obstetric Labor Complications; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 26, 2024
• Study Start: May 10, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: December 2025
• Access Criteria: GS\ NP1

Locations

VN (1)