Pregnant WomenNCT02788383
Fetal RhD Genotye Non Invasive Prenatal Determination
An observational study of Pregnant Women and Rh-Hr Blood-Group System, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Rh-Hr Blood-Group System
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant RhD negative women since January 2013 until December 2015
Who may be able to join
- Pregnant RhD negative women
Who cannot join
- Pregnant RhD positive women
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Obdulia Alejos, MD, oalejos@santpau.cat
Obdulia Alejos, MD
About this study
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
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.
Read the 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.
- Conditions
- Pregnant Women, Rh-Hr Blood-Group System
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal determination fetal RhD genotype
RhD negative/ RhD positive
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788383
- Sponsor's protocol ID
- IIBSP-RHD-2016-18
- Status last verified
- Jun 2016
- First submitted
- 27 May 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02788383
- Acronym / sponsor ID
- IIBSP-RHD-2016-18
- Conditions
- Pregnant Women, Rh-Hr Blood-Group System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant RhD negative women since January 2013 until December 2015
Key inclusion criteria (1 listed)
- Pregnant RhD negative women
Key exclusion criteria (1 listed)
- Pregnant RhD positive women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prenatal determination fetal RhD genotype
Time frame: Ten months
RhD negative/ RhD positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Rh-Hr Blood-Group System, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Obdulia Alejos, MD (+34935565760, oalejos@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal determination fetal RhD genotype (time frame: Ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.