Fetal RhD Genotye Non Invasive Prenatal Determination

June 20, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Unknown

Conditions

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.

I'm going to check the clinical history of all negative RhD pregnant women since January 2013 until December 2015.

I'll 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 hasn't been necessary thanks to prenatal determination.

This is an important thing because gammaglobulin is an humanoid product ( it isn't 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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Obdulia Alejos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant RhD negative women since January 2013 until December 2015

Description

Inclusion Criteria:

  • Pregnant RhD negative women

Exclusion Criteria:

  • Pregnant RhD positive women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prenatal determination fetal RhD genotype
Time Frame: Ten months
RhD negative/ RhD positive
Ten months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • IIBSP-RHD-2016-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnant Women

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe