Ignite Creation Date:
2024-05-06 @ 8:37 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02788383
Status:
UNKNOWN
Last Update Posted:
2016-06-22
First Post:
2016-05-27
Brief Title:
Fetal RhD Genotye Non Invasive Prenatal Determination
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Aplicación en la práctica clínica de la determinación Prenatal no Invasiva en el Genotipo RhD Fetal Durante el Primer Trimestre de la gestación en Gestantes RhD Negativas
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
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:
Actually our center is doing the prenatal determination of RhD fetal genotype in all RhD negative pregnant women
The investigator want to demonstrate that this is an useful and efficient method
The investigator want to demonstrate that this is an useful and efficient method
Detailed Description:
This is a retrospective observational study that pretend to demonstrate that the prenatal determination of RhD fetal genotype is useful and efficient in our clinical practice
Im going to check the clinical history of all negative RhD pregnant women since January 2013 until December 2015
Ill check if prenatal determination matches with postnatal RhD determination of newborn
Usually when a RhD negative woman is pregnant we administrate gammaglobulin in 28 gestation weeks after invasive procedures and after delivery if the baby is positive RhD
Althought the investigators know that the 40 percent of RhD negative pregnant have a negative RhD baby
This study will do posible to know how many gammaglobulins hasnt been necessary thanks to prenatal determination
This is an important thing because gammaglobulin is an humanoid product it isnt without heatlth risks and because is expensive
For this reason if the investigators do universal determination of RhD fetal genotype the investigators can avoid the administration of humanoid product in pregnant women
I want to demonstrate that this practice is very useful and efficient in our population
Im going to check the clinical history of all negative RhD pregnant women since January 2013 until December 2015
Ill check if prenatal determination matches with postnatal RhD determination of newborn
Usually when a RhD negative woman is pregnant we administrate gammaglobulin in 28 gestation weeks after invasive procedures and after delivery if the baby is positive RhD
Althought the investigators know that the 40 percent of RhD negative pregnant have a negative RhD baby
This study will do posible to know how many gammaglobulins hasnt been necessary thanks to prenatal determination
This is an important thing because gammaglobulin is an humanoid product it isnt without heatlth risks and because is expensive
For this reason if the investigators do universal determination of RhD fetal genotype the investigators can avoid the administration of humanoid product in pregnant women
I want to demonstrate that this practice is very useful and efficient in our population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None