Small for Gestational Age (Disorder)NCT02031393
Establishing First Trimester Markers for the Identification of High Risk Twin
An observational study of Small for Gestational Age (Disorder) and Pre-Eclampsia, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Small for Gestational Age (Disorder), Pre-Eclampsia
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Jul 2014
- How long will I take part?
- 9 Months
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women that will come to our first trimester clinic inorder to preform first trimester screeninig
Who may be able to join
- pregnant women from 11 -14 weeks of gestation
Who cannot join
- nuchal thickness above 3 mm,
- Chronic hypertension,
- thrombophilia,
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester
The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.
- Medical subject headings
- Pre-Eclampsia
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 |
|---|---|---|
| singelton pregnancy | will be followed 11-14 weeks and 19-28 weeks of gestation and after birth | |
| twin pregnancy | will be followed 11-14 weeks and 19-28 weeks of gestation and after birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of preeclampsia
the women will be approached after birth to asses whether they developed preeclampsia or pregnancy induced hypertension
Measured: after delivery
Secondary outcomes (1)
intra uterine growth restriction
Measured: after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startSep 2009
- Primary completionJan 2014
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational Age (Disorder)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031393
- Sponsor's protocol ID
- 217/13
- Status last verified
- Dec 2013
- First submitted
- 8 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester
- ClinicalTrials.gov ID
- NCT02031393
- Acronym / sponsor ID
- 217/13
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 9 Jan 2014 (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.
The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| singelton pregnancy | – | –will be followed 11-14 weeks and 19-28 weeks of gestation and after birth |
| twin pregnancy | – | –will be followed 11-14 weeks and 19-28 weeks of gestation and after birth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women that will come to our first trimester clinic inorder to preform first trimester screeninig
Key inclusion criteria (1 listed)
- pregnant women from 11 -14 weeks of gestation
Key exclusion criteria (4 listed)
- nuchal thickness above 3 mm,
- Chronic hypertension,
- thrombophilia,
- Diabetes
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
The development of preeclampsia
Time frame: after delivery
the women will be approached after birth to asses whether they developed preeclampsia or pregnancy induced hypertension
1 secondary outcome
intra uterine growth restriction
Time frame: after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
Related trials for Small for Gestational Age (Disorder)
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome
RecruitingPhase 3
The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
Venous Thromboembolism, Postpartum Period
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.
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 Small for Gestational Age (Disorder) and Pre-Eclampsia, run by Assaf-Harofeh Medical Center 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 1 inclusion and 4 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 31 Jan 2014. 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?
Results are not available in the source record.
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?
The development of preeclampsia (time frame: after delivery). 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 31 Jan 2014.