Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-22
Brief Title:
Developing Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test
Sponsor:
Gene Solutions
Organization:
Gene Solutions
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PEeclampsia 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None