Clinical trial NCT06385366: 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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnant With Complication
Preeclampsia
Preterm Birth
Gestational Diabetes
Keywords: cffDNA
cfRNA
Vietnam
Lead sponsor: Gene Solutions
Sponsor class: INDUSTRY
Collaborators: name: Medical Genetics Institute (MGI)
First posted: 2024-04-26
Enrollment: 1105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation)
timeFrame: 12 months
measure: Characteristics of pregnant women at recruitment
timeFrame: 12 months
measure: Define the significant differences between cases and controls
timeFrame: 12 months
measure: The development of learning machine models
timeFrame: 12 months
measure: Evaluation of the developed models
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MGI
name: Hoa Giang, PhD
role: PRINCIPAL_INVESTIGATOR
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