Fetal Growth RestrictionNCT04311749
Expanded NIPT for Pregnancy Complications
An observational study of Fetal Growth Restriction and Preeclampsia Severe, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fetal Growth Restriction, Preeclampsia Severe
- What is being tested?
- Expanded panel cell free DNA testing (non-invasive prenatal testing), Placental biopsy and Umbilical cord blood
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 30 Aug 2024
- 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 to 60 years
- Women only
- Adult
Study population: This study includes pregnant women diagnosed with severe, early onset, unexplained fetal growth restriction.
Who may be able to join
- Diagnosis of early onset (< 34 weeks) severe fetal growth restriction, defined as estimated fetal weight less than 10th percentile with abnormal umbilical artery Dopplers OR estimated fetal weight less than 5th percentile alone OR biometric size at least 14 days behind expected dates
Who cannot join
- Maternal age < 18 years
- Multifetal gestation
- Chronic hypertension require use of pharmacotherapy
- Tobacco or drug use
- Major congenital malformations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: The Role of Expanded Panel Non-Invasive Prenatal Testing in Identifying Rare Autosomal Trisomies in Pregnancies With Placentally-Mediated Complications
This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.
- Conditions
- Fetal Growth Restriction, Preeclampsia Severe
- Being tested
- Expanded panel cell free DNA testing (non-invasive prenatal testing), Placental biopsy, Umbilical cord blood
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded panel cell free DNA testing (non-invasive prenatal testing)Genetic
Maternal blood sampling
Placental biopsyGenetic
Post-delivery placental sampling
Umbilical cord bloodGenetic
Post-delivery umbilical cord blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Fetal growth restriction | Not described Receives: Genetic: Expanded panel cell free DNA testing (non-invasive prenatal testing); Genetic: Placental biopsy; Genetic: Umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse pregnancy outcome
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Preterm birth < 34 weeks
Measured: Through study completion, an average of 2 years
Neonatal intensive care unit admission
Measured: Through study completion, an average of 2 years
Intrauterine fetal demise
Death of fetus prior to delivery
Measured: Through study completion, an average of 2 years
Neonatal demise
Death of infant within 28 days of birth
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start12 Feb 2020
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Sobhani, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311749
- Sponsor's protocol ID
- 19-27769
- Status last verified
- Oct 2024
- First submitted
- 5 Mar 2020
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Expanded Panel Non-Invasive Prenatal Testing in Identifying Rare Autosomal Trisomies in Pregnancies With Placentally-Mediated Complications
- ClinicalTrials.gov ID
- NCT04311749
- Acronym / sponsor ID
- 19-27769
- Conditions
- Fetal Growth Restriction, Preeclampsia Severe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 17 Mar 2020 (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.
This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal growth restriction | – | Genetic: Expanded panel cell free DNA testing (non-invasive prenatal testing), Genetic: Placental biopsy, Genetic: Umbilical cord blood |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This study includes pregnant women diagnosed with severe, early onset, unexplained fetal growth restriction.
Key inclusion criteria (1 listed)
- Diagnosis of early onset (< 34 weeks) severe fetal growth restriction, defined as estimated fetal weight less than 10th percentile with abnormal umbilical artery Dopplers OR estimated fetal weight less than 5th percentile alone OR biometric size at least 14 days behind expected dates
Key exclusion criteria (5 listed)
- Maternal age < 18 years
- Multifetal gestation
- Chronic hypertension require use of pharmacotherapy
- Tobacco or drug use
- Major congenital malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded panel cell free DNA testing (non-invasive prenatal testing)Maternal blood sampling | Genetic | Fetal growth restriction |
| Placental biopsyPost-delivery placental sampling | Genetic | Fetal growth restriction |
| Umbilical cord bloodPost-delivery umbilical cord blood sampling | Genetic | Fetal growth restriction |
Primary outcome
Composite adverse pregnancy outcome
Time frame: Through study completion, an average of 2 years
4 secondary outcomes
Preterm birth < 34 weeks
Time frame: Through study completion, an average of 2 years
Neonatal intensive care unit admission
Time frame: Through study completion, an average of 2 years
Intrauterine fetal demise
Time frame: Through study completion, an average of 2 years
Neonatal demise
Time frame: Through study completion, an average of 2 years
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 18 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Nasim Sobhani, MD principal investigator
University of California, San Francisco
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 Fetal Growth Restriction and Preeclampsia Severe, run by University of California, San Francisco at 1 site in United States.
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 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 18 Oct 2024. 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 United States. 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?
Composite adverse pregnancy outcome (time frame: Through study completion, an average of 2 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 18 Oct 2024.