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

July 12, 2025 updated by: Gene Solutions

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)

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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Hồ Chí Minh
      • Ho Chi Minh City, Hồ Chí Minh, Vietnam
        • Medical Genetics Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  1. 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

  2. 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.
  3. NIPT blood sample is available according to post-test sample storage procedures at Gene Solutions Lab.
  4. Consent to voluntarily participate in the study

Exclusion Criteria:

  1. Multiple pregnancies
  2. Pregnancy with any genetic abnormality
  3. Pregnancy with any fetal structural abnormality
  4. Pregnancy with indications for termination, miscarriage, or stillbirth due to other complications
  5. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Characteristics of pregnant women at recruitment
Time Frame: 12 months
Characteristics of pregnant women at recruitment: clinical features, cffDNA, cfRNA
12 months
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
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gene Solutions

Collaborators

Medical Genetics Institute (MGI)

Investigators

  • Principal Investigator: Hoa Giang, PhD, MGI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2024

Primary Completion (Estimated)

November 6, 2025

Study Completion (Estimated)

November 6, 2025

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 12, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS_NP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data of this study may be requested for publication by the journals. Sharing anonymized data with suitable study will be decided by the Sponsor, Principles Investigator and the authority agency. No identifiable information will be share with any other person or organization than authorized in this study.

IPD Sharing Time Frame

December 2025

IPD Sharing Access Criteria

GS_NP1

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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