Retardation, Fetal GrowthADEPTNCT02478554
Antenatal Development Evaluated Prospectively
A study testing Customized fetal growth curves in people with Retardation, Fetal Growth and Macrosomia, Fetal, run by The University of Texas Health Science Center, Houston.
Trial summary
Fetal growth abnormalities is one of the most common problems faced in modern obstetrics. The association between low birth weight and perinatal death as well as severe morbidity is well known. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Retardation, Fetal Growth, Macrosomia, Fetal
- What is being tested?
- Customized fetal growth curves
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age greater than or equal to 24 weeks gestation.
- Maternal age over 18 years,
- Prior normal fetal anatomy ultrasound done at main ultrasound unit
Who cannot join
- 1. Pregnancies carrying higher order multiples (triplets, quadruplets, etc).
About this study
Official title: Customized Versus Population Fetal Growth Curves: A Randomized Controlled Pilot Trial
Fetal growth abnormalities is one of the most common problems faced in modern obstetrics. The association between low birth weight and perinatal death as well as severe morbidity is well known. Since fetal weight cannot be measured directly, obstetricians use estimates of fetal weight obtained by utilizing various ultrasonographic measurements to diagnose growth abnormalities. Currently in clinical practice, the majority of fetal ultrasound centers employ population-based fetal growth curves that have been previously published and updated to estimate fetal weight percentiles. Up to 70% of neonates found to be below the 10% percentile for estimated fetal weight in population-based growth curves are actually constitutionally small; that is a neonate deemed "small" based on standardized growth curves but in reality have reached its appropriate growth potential in relation to its genetic predisposition.
An equally difficult clinical scenario is fetal macrosomia. A recent meta-analysis revealed that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from 15-79%. When compared with neonates with normal birth weight, the odds ratio of emergency cesarean delivery and shoulder dystocia are increased significantly.
Read more
Various ultrasound parameters have been tested in an effort to detect both fetal compromise prior to the development of permanent damage and allow differentiation between true fetal growth abnormalities and normal growth potential. Recent reports have introduced the concept of customized fetal growth curve which uses physiological variables to report an adjusted fetal growth assessment. To date, the use of customized fetal growth curves has not been evaluated prospectively. Furthermore, this strategy has not been compared to standard population-based fetal growth curves currently used in clinical practice to determine which would be the most ideal for use in clinical practice.
The primary research question is: are customized fetal growth curves more accurate than population-based fetal growth curves at predicting abnormalities in fetal growth, defined as small-for-gestational age or large-for-gestational age at birth in newborns of high-risk pregnancies? Randomly, participants will be assigned to either having fetal growth reported by customized or population bases growth curves.
- Conditions
- Retardation, Fetal Growth, Macrosomia, Fetal
- Being tested
- Customized fetal growth curves
- Keywords
- Fetal growth restriction, macrosomia
- Medical subject headings
- Fetal Growth Retardation, Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized fetal growth curvesOther
Fetal weight will be plotted against growth curves specific for height, weight, parity and ethnicity
| Study group | Role | What they receive |
|---|---|---|
| Population-based | No intervention | Participants will be randomly assigned to population-based fetal growth curves |
| Customized-based | Active comparator | Participants will be randomly assigned to customized-based fetal growth curves (intervention) Receives: Other: Customized fetal growth curves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of fetal growth abnormalities
Birth weight will be used to confirm prenatal diagnosis of fetal growth abnormality
Measured: Participants will be followed from 24 weeks gestation to 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016 (estimated)
Why it stopped: Not IRB approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retardation, Fetal GrowthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478554
- Sponsor's protocol ID
- HSC-MS-15-0536
- Acronym
- ADEPT
- Status last verified
- Jun 2018
- First submitted
- 10 Jun 2015
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Versus Population Fetal Growth Curves: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02478554
- Acronym / sponsor ID
- ADEPT / HSC-MS-15-0536
- Conditions
- Retardation, Fetal Growth, Macrosomia, Fetal
- Keywords
- Fetal growth restriction, macrosomia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not IRB approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 23 Jun 2015 (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.
Fetal growth abnormalities is one of the most common problems faced in modern obstetrics. The association between low birth weight and perinatal death as well as severe morbidity is well known. Since fetal weight cannot be measured directly, obstetricians use estimates of fetal weight obtained by utilizing various ultrasonographic measurements to diagnose growth abnormalities. Currently in clinical practice, the majority of fetal ultrasound centers employ population-based fetal growth curves that have been previously published and updated to estimate fetal weight percentiles. Up to 70% of neonates found to be below the 10% percentile for estimated fetal weight in population-based growth curves are actually constitutionally small; that is a neonate deemed "small" based on standardized growth curves but in reality have reached its appropriate growth potential in relation to its genetic predisposition.
An equally difficult clinical scenario is fetal macrosomia. A recent meta-analysis revealed that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from 15-79%. When compared with neonates with normal birth weight, the odds ratio of emergency cesarean delivery and shoulder dystocia are increased significantly.
Various ultrasound parameters have been tested in an effort to detect both fetal compromise prior to the development of permanent damage and allow differentiation between true fetal growth abnormalities and normal growth potential. Recent reports have introduced the concept of customized fetal growth curve which uses physiological variables to report an adjusted fetal growth assessment. To date, the use of customized fetal growth curves has not been evaluated prospectively. Furthermore, this strategy has not been compared to standard population-based fetal growth curves currently used in clinical practice to determine which would be the most ideal for use in clinical practice.
The primary research question is: are customized fetal growth curves more accurate than population-based fetal growth curves at predicting abnormalities in fetal growth, defined as small-for-gestational age or large-for-gestational age at birth in newborns of high-risk pregnancies? Randomly, participants will be assigned to either having fetal growth reported by customized or population bases growth curves.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population-based | No intervention | –Participants will be randomly assigned to population-based fetal growth curves |
| Customized-based | Active comparator | Other: Customized fetal growth curvesParticipants will be randomly assigned to customized-based fetal growth curves (intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age greater than or equal to 24 weeks gestation.
- Maternal age over 18 years,
- Prior normal fetal anatomy ultrasound done at main ultrasound unit
Key exclusion criteria (1 listed)
- 1. Pregnancies carrying higher order multiples (triplets, quadruplets, etc).
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 |
|---|---|---|
| Customized fetal growth curvesFetal weight will be plotted against growth curves specific for height, weight, parity and ethnicity | Other | Customized-based |
Primary outcome
Detection of fetal growth abnormalities
Time frame: Participants will be followed from 24 weeks gestation to 2 weeks postpartum
Birth weight will be used to confirm prenatal diagnosis of fetal growth abnormality
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Customized fetal growth curves in people with Retardation, Fetal Growth and Macrosomia, Fetal, run by The University of Texas Health Science Center, Houston.
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 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: withdrawn, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Detection of fetal growth abnormalities (time frame: Participants will be followed from 24 weeks gestation to 2 weeks postpartum). 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 2 Jul 2018.