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NCT Number: NCT06385366

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

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.

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Key information

Conditions

Pregnant With Complication Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pre-Eclampsia Preeclampsia Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Medical Genetics Institute

Ho Chi Minh City, Hồ Chí Minh, Vietnam

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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).

Treatment and study plan

Primary outcomes

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

    Time frame: 12 months

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

  2. Characteristics of pregnant women at recruitment

    Time frame: 12 months

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

  3. Define the significant differences between cases and controls

    Time frame: 12 months

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

  4. The development of learning machine models

    Time frame: 12 months

    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.

  5. Evaluation of the developed models

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Gene Solutions

Industry

Collaborators

  • Medical Genetics Institute (MGI)

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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