Intrauterine Growth RestrictionNCT04213443
Fetal Growth Pattern in Short Stature Women
An observational study of Intrauterine Growth Restriction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Analysis of a patient registry
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2020to 11 Mar 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women of short stature under 1.6 meters.
Who may be able to join
- Women under 1.6 meters of height.
- Singleton pregnancy.
- Low risk pregnancy.
- Accurate dating.
Who cannot join
- Women over 1.6 meters of height.
- Multiple pregnancy.
- High risk pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Growth Pattern in Short Stature Women as a Model for True Intrauterine Growth Restriction Prediction.
Women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.
Read the detailed description
Based on a patient registry, women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.
Informed consent is not required due to the retrospective nature of the study. Patient information including medical, obstetric and general background will be collected.
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Analysis of a patient registry
- 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.
Analysis of a patient registryOther
Analysis of a patient registry.
| Study group | Role | What they receive |
|---|---|---|
| Women of short stature | Women that are under 1.6 meters. Receives: Other: Analysis of a patient registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated fetal weight changes.
Changes in estimated fetal weight during pregnancy.
Measured: Up to 1 year from admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start31 Dec 2020
- Primary completion28 Feb 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam healthcare campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213443
- Sponsor's protocol ID
- 0275-19-RMB
- Status last verified
- Mar 2021
- First submitted
- 26 Dec 2019
- Last updated
- 17 Mar 2021
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Growth Pattern in Short Stature Women as a Model for True Intrauterine Growth Restriction Prediction.
- ClinicalTrials.gov ID
- NCT04213443
- Acronym / sponsor ID
- 0275-19-RMB
- Conditions
- Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 30 Dec 2019 (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.
Women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.
Detailed description
Based on a patient registry, women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.
Informed consent is not required due to the retrospective nature of the study. Patient information including medical, obstetric and general background will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women of short stature | – | Other: Analysis of a patient registryWomen that are under 1.6 meters. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women of short stature under 1.6 meters.
Key inclusion criteria (4 listed)
- Women under 1.6 meters of height.
- Singleton pregnancy.
- Low risk pregnancy.
- Accurate dating.
Key exclusion criteria (3 listed)
- Women over 1.6 meters of height.
- Multiple pregnancy.
- High risk pregnancy.
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 |
|---|---|---|
| Analysis of a patient registryAnalysis of a patient registry. | Other | Women of short stature |
Primary outcome
Estimated fetal weight changes.
Time frame: Up to 1 year from admission.
Changes in estimated fetal weight during pregnancy.
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 17 Mar 2021.
- 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.
Roy Lauterbach, MD principal investigator
Rambam healthcare campus
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 Intrauterine Growth Restriction, run by Rambam Health Care Campus at 1 site in Israel.
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 4 inclusion and 3 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 17 Mar 2021. 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 Israel. 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?
Estimated fetal weight changes. (time frame: Up to 1 year from admission.). 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 17 Mar 2021.