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

Gene Solutions

Status: Invitation-only

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

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06385366

GS_NP1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,105 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).