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Enrolling by invitation NCT06385366

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

— Observational Pregnant With Complication Preeclampsia Preterm Birth Gestational Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pregnant With Complication, Preeclampsia, Preterm Birth, Gestational Diabetes. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Primary outcome measures

  • Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation) [Time frame: 12 months]
  • Characteristics of pregnant women at recruitment [Time frame: 12 months]
  • Define the significant differences between cases and controls [Time frame: 12 months]
  • The development of learning machine models [Time frame: 12 months]
  • Evaluation of the developed models [Time frame: 12 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Vietnam · 1 center
  • Medical Genetics Institute — Ho Chi Minh City

Publications

  • Brosens I, Pijnenborg R, Vercruysse L, Romero R. The "Great Obstetrical Syndromes" are associated with disorders of deep placentation. Am J Obstet Gynecol. 2011 Mar;204(3):193-201. doi: 10.1016/j.ajog.2010.08.009. Epub 2010 Nov 20. PMID 21094932
  • Gabbay-Benziv R, Baschat AA. Gestational diabetes as one of the "great obstetrical syndromes"--the maternal, placental, and fetal dialog. Best Pract Res Clin Obstet Gynaecol. 2015 Feb;29(2):150-5. doi: 10.1016/j.bpobgyn.2014.04.025. Epub 2014 Aug 20. PMID 25225057
  • Chaemsaithong P, Sahota DS, Poon LC. First trimester preeclampsia screening and prediction. Am J Obstet Gynecol. 2022 Feb;226(2S):S1071-S1097.e2. doi: 10.1016/j.ajog.2020.07.020. Epub 2020 Jul 16. PMID 32682859
  • Rani PR, Begum J. Screening and Diagnosis of Gestational Diabetes Mellitus, Where Do We Stand. J Clin Diagn Res. 2016 Apr;10(4):QE01-4. doi: 10.7860/JCDR/2016/17588.7689. Epub 2016 Apr 1. PMID 27190902
  • Reicher L, Fouks Y, Yogev Y. Cervical Assessment for Predicting Preterm Birth-Cervical Length and Beyond. J Clin Med. 2021 Feb 7;10(4):627. doi: 10.3390/jcm10040627. PMID 33562187
  • Hod M, Lieberman N. Maternal-fetal medicine--how can we practically connect the "M" to the "F"? Best Pract Res Clin Obstet Gynaecol. 2015 Feb;29(2):270-83. doi: 10.1016/j.bpobgyn.2014.06.008. Epub 2014 Aug 21. PMID 25225060
  • Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15. PMID 27640943
  • Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815. PMID 17671254

Identifiers

NCT: NCT06385366 · GS_NP1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗