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Pregnant With ComplicationNCT06385366

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

An observational study of Pregnant With Complication and Preeclampsia, run by Gene Solutions at 1 site in Vietnam.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
How many people
1,105 participants
Where
1 siteVietnam
Study dates
10 May 2024to 6 Nov 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam1 site

  • Medical Genetics Institute

    Ho Chi Minh City, Hồ Chí Minh

Other trials in Vietnam

About this study

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)

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.

Read the 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.

Keywords
cffDNA, cfRNA, Vietnam
Medical subject headings
Pregnancy Complications, Pre-Eclampsia, Premature Birth, Diabetes, Gestational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. Characteristics of pregnant women at recruitment

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

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start10 May 2024
  3. Primary completion6 Nov 2025 (estimated)
  4. Study completion6 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06385366
Sponsor's protocol ID
GS_NP1
Status last verified
Jul 2025
First submitted
22 Apr 2024
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 17671254

  • Becking EC, Scheffer PG, Henrichs J, Bax CJ, Crombag NMTH, Weiss MM, Macville MVE, Van Opstal D, Boon EMJ, Sistermans EA, Henneman L, Schuit E, Bekker MN. Fetal fraction of cell-free DNA in noninvasive prenatal testing and adverse pregnancy outcomes: a nationwide retrospective cohort study of 56,110 pregnant women. Am J Obstet Gynecol. 2024 Aug;231(2):244.e1-244.e18. doi: 10.1016/j.ajog.2023.12.008. Epub 2023 Dec 12.

    PubMed 38097030

  • Karapetian capital A, Cyrilliccapital O, Cyrillic, Baev capital O, CyrillicR, Sadekova capital A, Cyrilliccapital A, Cyrillic, Krasnyi capital A, Cyrilliccapital EM, Cyrillic, Sukhikh GT. Cell-Free Foetal DNA as a Useful Marker for Preeclampsia Prediction. Reprod Sci. 2021 May;28(5):1563-1569. doi: 10.1007/s43032-021-00466-w. Epub 2021 Jan 21.

    PubMed 33475978

  • Munchel S, Rohrback S, Randise-Hinchliff C, Kinnings S, Deshmukh S, Alla N, Tan C, Kia A, Greene G, Leety L, Rhoa M, Yeats S, Saul M, Chou J, Bianco K, O'Shea K, Bujold E, Norwitz E, Wapner R, Saade G, Kaper F. Circulating transcripts in maternal blood reflect a molecular signature of early-onset preeclampsia. Sci Transl Med. 2020 Jul 1;12(550):eaaz0131. doi: 10.1126/scitranslmed.aaz0131.

    PubMed 32611681

  • Zhou S, Li J, Yang W, Xue P, Yin Y, Wang Y, Tian P, Peng H, Jiang H, Xu W, Huang S, Zhang R, Wei F, Sun HX, Zhang J, Zhao L. Noninvasive preeclampsia prediction using plasma cell-free RNA signatures. Am J Obstet Gynecol. 2023 Nov;229(5):553.e1-553.e16. doi: 10.1016/j.ajog.2023.05.015. Epub 2023 May 19.

    PubMed 37211139

  • Dugoff L, Barberio A, Whittaker PG, Schwartz N, Sehdev H, Bastek JA. Cell-free DNA fetal fraction and preterm birth. Am J Obstet Gynecol. 2016 Aug;215(2):231.e1-7. doi: 10.1016/j.ajog.2016.02.009. Epub 2016 Feb 11.

    PubMed 26875947

  • Darghahi R, Mobaraki-Asl N, Ghavami Z, Pourfarzi F, Hosseini-Asl S, Jalilvand F. Effect of cell-free fetal DNA on spontaneous preterm labor. J Adv Pharm Technol Res. 2019 Jul-Sep;10(3):117-120. doi: 10.4103/japtr.JAPTR_371_18.

    PubMed 31334093

  • Camunas-Soler J, Gee EPS, Reddy M, Mi JD, Thao M, Brundage T, Siddiqui F, Hezelgrave NL, Shennan AH, Namsaraev E, Haverty C, Jain M, Elovitz MA, Rasmussen M, Tribe RM. Predictive RNA profiles for early and very early spontaneous preterm birth. Am J Obstet Gynecol. 2022 Jul;227(1):72.e1-72.e16. doi: 10.1016/j.ajog.2022.04.002. Epub 2022 Apr 6.

    PubMed 35398029

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnant With Complication and Preeclampsia, run by Gene Solutions at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06385366, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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