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

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ClinicalTrials.gov Identifier: NCT06385366
Recruitment Status : Not yet recruiting
First Posted : April 26, 2024
Last Update Posted : April 30, 2024
Sponsor:
Collaborator:
Medical Genetics Institute (MGI)
Information provided by (Responsible Party):
Gene Solutions

Tracking Information
First Submitted Date April 22, 2024
First Posted Date April 26, 2024
Last Update Posted Date April 30, 2024
Estimated Study Start Date May 15, 2024
Estimated Primary Completion Date May 6, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2024)
  • 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
  • Characteristics of pregnant women at recruitment [ Time Frame: 12 months ]
    Characteristics of pregnant women at recruitment: clinical features, cffDNA, cfRNA
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test
Official 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)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.
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.
Condition
  • Pregnant With Complication
  • Preeclampsia
  • Preterm Birth
  • Gestational Diabetes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 22, 2024)		 1105
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 6, 2025
Estimated Primary Completion Date May 6, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sang H Sang, MSc, MD +84932198107 sangtang@genesolutions.vn
Contact: VAN T Phan, MSc +84908145990 vanphan@genesolutions.vn
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT06385366
Other Study ID Numbers GS_NP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: December 2025
Access Criteria: GS_NP1
Current Responsible Party Gene Solutions
Original Responsible Party Same as current
Current Study Sponsor Gene Solutions
Original Study Sponsor Same as current
Collaborators Medical Genetics Institute (MGI)
Investigators
Principal Investigator: Hoa Giang, PhD MGI
PRS Account Gene Solutions
Verification Date April 2024