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

Not yet recruiting

• Conditions: Preeclampsia; Pregnant With Complication; Gestational Diabetes; Preterm Birth

• Registration Number: NCT06385366
• Lead Sponsor: Gene Solutions

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-26
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30
• Study Start: 2024-05-15
• Primary Completion: 2025-05-06
• Study Completion: 2025-06-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characteristics of pregnant women at recruitment	12 months	Characteristics of pregnant women at recruitment: clinical features, cffDNA, cfRNA
Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation)	12 months	Observe the characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation): clinical features, cffDNA, cfRNA
The development of learning machine models	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.
Define the significant differences between cases and controls	12 months	Comparison between clinical features, cffDNA, and cfRNA of early pregnancy and at recruitment, then defines the significant differences between cases and controls
Evaluation of the developed models	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.