PREGNANCYNCT01882738
Effect of Maternal BMI on Measurement of Cervical Length
An observational study of PREGNANCY, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PREGNANCY
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Jul 2015
- 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
- Healthy volunteers accepted
- Adult
Study population: All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam
Who may be able to join
- All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam
Who cannot join
- Known shore cervix
- PPROM
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera
Alon Shrim, MD, +972-50-6246988, alon.shrim@gmail.com
Ron Belosseski, MD, +972-50-6246988, TOMOR2304@YAHOO.COM
About this study
Official title: Effect of Maternal BMI on Accuracy of Measurement of Cervical Length During the 3rd Trimester of Pregnancy
All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI
Read the detailed description
This study will include pregnant women in either 2nd or 3rd trimester of pregnancy. All consecutive pregnant patients in 2nd or 3rd trimester who will attend our unit for routine ultrasound exam will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI. Accuracy would be defind as the delta of cervical length between abdominal and vaginal routs.
BMI would be calculated prior to the ultrasound exam (by weighing and measuring all patients).
- Conditions
- PREGNANCY
- Keywords
- Cervical length, BMI
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of cervical length according to BMI
the golden standard for cervical length measurement is vaginal scan. Our outcome measure will be the accuracy of cervical length measurement - measured abdominally, according to BMI. I other words - was there a difference between measurement by vaginal probe and abdominal probe and whether this difference correlates with BMI
Measured: 1 year
Secondary outcomes (1)
Gestational age at delivery according to cervical length
Gestational age at delivery according to cervical length
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREGNANCYStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882738
- Sponsor's protocol ID
- 0039-13-HYMC
- Status last verified
- Jun 2013
- First submitted
- 11 Jun 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal BMI on Accuracy of Measurement of Cervical Length During the 3rd Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT01882738
- Acronym / sponsor ID
- 0039-13-HYMC
- Conditions
- PREGNANCY
- Keywords
- Cervical length, BMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 20 Jun 2013 (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.
All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI
Detailed description
This study will include pregnant women in either 2nd or 3rd trimester of pregnancy. All consecutive pregnant patients in 2nd or 3rd trimester who will attend our unit for routine ultrasound exam will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI. Accuracy would be defind as the delta of cervical length between abdominal and vaginal routs.
BMI would be calculated prior to the ultrasound exam (by weighing and measuring all patients).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam
Key inclusion criteria (1 listed)
- All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam
Key exclusion criteria (2 listed)
- Known shore cervix
- PPROM
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
Accuracy of cervical length according to BMI
Time frame: 1 year
the golden standard for cervical length measurement is vaginal scan. Our outcome measure will be the accuracy of cervical length measurement - measured abdominally, according to BMI. I other words - was there a difference between measurement by vaginal probe and abdominal probe and whether this difference correlates with BMI
1 secondary outcome
Gestational age at delivery according to cervical length
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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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.
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 PREGNANCY, run by Hillel Yaffe 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 2 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 20 Jun 2013. 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?
Contact Alon Shrim, MD (+972-50-6246988, alon.shrim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of cervical length according to BMI (time frame: 1 year). 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 20 Jun 2013.