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

Launched by GENE SOLUTIONS · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict certain complications during pregnancy, such as preeclampsia (a condition that can cause high blood pressure), preterm birth, and gestational diabetes. Researchers want to see if they can use a simple blood test that looks at tiny pieces of DNA and RNA from the fetus, combined with some clinical information about the mother, to identify women who might be at higher risk for these complications. This study is particularly focused on pregnant women in Vietnam.

To be eligible for this trial, participants must be women who are pregnant with one baby and either have been diagnosed with one of the conditions mentioned or are having a healthy pregnancy at 37 weeks or more. They must also have had a specific non-invasive prenatal test earlier in their pregnancy that showed low risk for abnormalities. Women with multiple pregnancies, certain medical histories, or specific complications are not eligible to join. Those who participate can expect to contribute their past test results and blood samples, and they will help researchers learn more about how to improve prenatal care for mothers and babies.

Gender

FEMALE

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).