Pregnancy RelatedNCT03590678
Collection of Whole Blood Specimens in Pregnant Women
An observational study of Pregnancy Related, run by Illumina, Inc. at 16 sites in 6 countries.
Trial summary
To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- How many people
- 3,000 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 13 Feb 2017to 31 Dec 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a viable pregnancy of at least 10 weeks, 0 days gestation who are scheduled for an invasive procedure performed per the standard of care.
Who may be able to join
- Be 18 years of age or older at enrollment,
- Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days gestation at the time of maternal specimen collection,
- Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus sampling [CVS], amniocentesis, or percutaneous umbilical cord blood sampling [cordocentesis]) for cytogenetic analysis of the fetus
Who cannot join
- Has a known maternal chromosomal anomaly,
- Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal specimen collection
- Has a history of transplant or malignancy, or
- Had a transfusion of blood or blood components up to 8 weeks before maternal whole blood specimen collection
- Already participated in this study (enrolled previously).
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United States5 sites
Practice Research Organization
Dallas, Texas, 75230
Desert Perinatal Associates
Las Vegas, Nevada, 89148
Center for Fetal Medicine
Los Angeles, California, 90048
Eastern Virgina Medical School, Dept Obstetrics and Gynecology, Maternal Fetal Medicine
Norfolk, Virginia, 23507
Maternal Fetal Medicine and Genetics
Riverside, California, 92506
Poland3 sites
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
CENTRUM INNOWACYJNYCH TERAPII Sp. z
Piaseczno, 05-500
FERTINA Sp. z o.o. SPÓŁKA KOMANDYTOWA
Warsaw, 00-172
Thailand3 sites
Phramongkutklao Hospital
Bangkok, 10400
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Songklanagarind Hospital
Songkhla, 90110
Ukraine3 sites
"Institute of general practice - family medicine"
Kyiv, 02132
LLC "Reproductive Genetics Clinic "Victoria"
Kyiv, 04070
Medical Center "Pulse", Small Private Business
Vinnytsia, 21001
Australia1 site
Mater Misericordiae Limited
South Brisbane, Queensland, 4101
About this study
Official title: Prospective Collection of Whole Blood Specimens in Pregnant Women
To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.
Read the detailed description
This is a prospective multicenter study in which whole blood specimens will be collected from pregnant women scheduled for an invasive procedure.
After the standard-of-care invasive procedure is performed in accordance with the site's clinical procedures, invasive prenatal diagnostic procedure results will also be collected.
- Conditions
- Pregnancy Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subject is scheduled for an invasive procedure and did not have NIPT testing in current pregnancy | |
| 2 | Subject is scheduled for an invasive procedure and has a known positive or no-call result from a targeted NIPT in the current pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Whole Blood Specimens in Pregnant Women
To collect maternal whole blood specimens from approximately 5,150 women with corresponding cytogenetic results from invasive prenatal diagnostic procedures (performed per the standard of care) to achieve sample size goals
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start13 Feb 2017
- Primary completion30 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illumina, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathryn Waldrep, MD, Principal investigator, Medical City Dallas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590678
- Sponsor's protocol ID
- RGH-015
- Status last verified
- May 2022
- First submitted
- 4 May 2017
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Whole Blood Specimens in Pregnant Women
- ClinicalTrials.gov ID
- NCT03590678
- Acronym / sponsor ID
- RGH-015
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Illumina, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- 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.
To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.
Detailed description
This is a prospective multicenter study in which whole blood specimens will be collected from pregnant women scheduled for an invasive procedure.
After the standard-of-care invasive procedure is performed in accordance with the site's clinical procedures, invasive prenatal diagnostic procedure results will also be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subject is scheduled for an invasive procedure and did not have NIPT testing in current pregnancy |
| 2 | – | –Subject is scheduled for an invasive procedure and has a known positive or no-call result from a targeted NIPT in the current pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a viable pregnancy of at least 10 weeks, 0 days gestation who are scheduled for an invasive procedure performed per the standard of care.
Key inclusion criteria (3 listed)
- Be 18 years of age or older at enrollment,
- Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days gestation at the time of maternal specimen collection,
- Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus sampling [CVS], amniocentesis, or percutaneous umbilical cord blood sampling [cordocentesis]) for cytogenetic analysis of the fetus
Key exclusion criteria (5 listed)
- Has a known maternal chromosomal anomaly,
- Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal specimen collection
- Has a history of transplant or malignancy, or
- Had a transfusion of blood or blood components up to 8 weeks before maternal whole blood specimen collection
- Already participated in this study (enrolled previously).
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
Collect Whole Blood Specimens in Pregnant Women
Time frame: 3 years
To collect maternal whole blood specimens from approximately 5,150 women with corresponding cytogenetic results from invasive prenatal diagnostic procedures (performed per the standard of care) to achieve sample size goals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
Kathryn Waldrep, MD principal investigator
Medical City Dallas Hospital
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Illumina, Inc. at 16 sites in 6 countries.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Poland, Thailand, Ukraine, Australia and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect Whole Blood Specimens in Pregnant Women (time frame: 3 years). 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 5 May 2022.