Maternal-Fetal RelationsNCT02510170
Fetal and Maternal Head Circumference During Pregnancy in Israeli Population
An observational study of Maternal-Fetal Relations and Microcephaly, run by Clalit Health Services at 1 site in Israel.
Trial summary
In this study, measurements of fetal and maternal head circumference will be collected. This data will be presented in table or graph form. The effect of maternal head circumference on fetal head circumference will be evaluated and presented in either formula or graph form. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Relations, Microcephaly
- How many people
- 188 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Jul 2016
- How long will I take part?
- 1 Day
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: primary care clinic
Who may be able to join
- Singleton pregnancy
- Valid first trimester sonogram
Who cannot join
- Women under 18 years of age
- Women over 40 years of age
- Multi fetal pregnancy
- No accurate dating of pregnancy age
- Participant non compliance or cannot complete contact details
- Technical difficulty measuring fetal or maternal skull
Show all 12Show fewer
- Abnormal fetal or maternal skull
- Familial hereditary disease, mental retardation
- Chronic maternal illness
- Maternal on chronic medication
- Abnormal screening test during current pregnancy
- Abnormal sugar metabolism or Hypertension during current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal and Maternal Head Circumference During Pregnancy
In this study, measurements of fetal and maternal head circumference will be collected. This data will be presented in table or graph form. The effect of maternal head circumference on fetal head circumference will be evaluated and presented in either formula or graph form.
- Conditions
- Maternal-Fetal Relations, Microcephaly
- Being tested
- no intervention
- Keywords
- Fetus, Skull, ultrasonography
- Medical subject headings
- Microcephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal head circumference (millimeters)
Israeli fetal population. Will be reported in table and / or graph form
Measured: 14 through 40 weeks pregnancy
Secondary outcomes (2)
Relationship of fetal head circumference (mm) to maternal head circumference (mm)
Calculating effect of maternal head circumference on fetal head circumference during pregnancy and adjusting (Formula) fetal head circumference normal values (+/- 2SD)
Measured: 14 through 40 weeks pregnancy where applicable
Maternal head circumference (millimeters)
Israeli maternal population. Will be reported in table and / or graph form
Measured: age 18 through 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal-Fetal RelationsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 188 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510170
- Sponsor's protocol ID
- COM150035CTIL
- Status last verified
- Jan 2016
- First submitted
- 19 Jul 2015
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal and Maternal Head Circumference During Pregnancy
- ClinicalTrials.gov ID
- NCT02510170
- Acronym / sponsor ID
- COM150035CTIL
- Conditions
- Maternal-Fetal Relations, Microcephaly
- Keywords
- Fetus, Skull, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Jul 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.
In this study, measurements of fetal and maternal head circumference will be collected. This data will be presented in table or graph form. The effect of maternal head circumference on fetal head circumference will be evaluated and presented in either formula or graph form.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Valid first trimester sonogram
Key exclusion criteria (12 listed)
- Women under 18 years of age
- Women over 40 years of age
- Multi fetal pregnancy
- No accurate dating of pregnancy age
- Participant non compliance or cannot complete contact details
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 |
|---|---|---|
| no intervention | Other | – |
Primary outcome
Fetal head circumference (millimeters)
Time frame: 14 through 40 weeks pregnancy
Israeli fetal population. Will be reported in table and / or graph form
2 secondary outcomes
Relationship of fetal head circumference (mm) to maternal head circumference (mm)
Time frame: 14 through 40 weeks pregnancy where applicable
Maternal head circumference (millimeters)
Time frame: age 18 through 40
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 14 Feb 2017.
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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.
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 Maternal-Fetal Relations and Microcephaly, run by Clalit Health Services 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 2 inclusion and 12 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 14 Feb 2017. 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?
Fetal head circumference (millimeters) (time frame: 14 through 40 weeks pregnancy). 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 14 Feb 2017.