PregnancyNCT00909376
Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?
An observational study of Pregnancy, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 450 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Dec 2010
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant women with one fetus who has no malformations.
Who may be able to join
- Pregnant women who choose to have a ultrasound done in the early second trimester.
Who cannot join
- More than one fetus,
- No agreement to participate in the study,
- Malformative fetus.
Trial locations and contacts
1 site in 1 country.
Ori Shen, MD contact
About this study
Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography.
The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Ultrasonography, outcome, adverse
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 |
|---|---|---|
| 1 - transabdominal sonography | Women who will have a transabdominal sonography done in the early second trimester. | |
| 2 - transvaginal sonography | Women who will have a transvaginal sonography done in the early second trimester. |
What is being measured
The primary outcome is the main question the study is designed to answer.
nuchal cord entanglement
Measured: at birth
Secondary outcomes (6)
SGA
Measured: at birth
Admission to intensive care unit
Measured: at birth
meconium
Measured: at birth
fetal distress
Measured: at birth
low APGAR score
Measured: 1 minute, 5 minutes after birth
need for c section
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ori Shen, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909376
- Sponsor's protocol ID
- 1-Ledmore
- Status last verified
- May 2009
- First submitted
- 2 Apr 2009
- Last updated
- 28 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?
- ClinicalTrials.gov ID
- NCT00909376
- Acronym / sponsor ID
- 1-Ledmore
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Ultrasonography, outcome, adverse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 May 2009 (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.
Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography.
The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - transabdominal sonography | – | –Women who will have a transabdominal sonography done in the early second trimester. |
| 2 - transvaginal sonography | – | –Women who will have a transvaginal sonography done in the early second trimester. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women with one fetus who has no malformations.
Key inclusion criteria (1 listed)
- Pregnant women who choose to have a ultrasound done in the early second trimester.
Key exclusion criteria (3 listed)
- More than one fetus,
- No agreement to participate in the study,
- Malformative fetus.
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
nuchal cord entanglement
Time frame: at birth
6 secondary outcomes
SGA
Time frame: at birth
Admission to intensive care unit
Time frame: at birth
meconium
Time frame: at birth
fetal distress
Time frame: at birth
low APGAR score
Time frame: 1 minute, 5 minutes after birth
need for c section
Time frame: at birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
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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.
Ori Shen, MD contact
Ori Shen, MD principal investigator
Shaare Zedek Medical Center
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 Shaare Zedek 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 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: status not confirmed, as of the sponsor's last update on 28 May 2009. 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 Ori Shen, MD (972-2-6666666), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nuchal cord entanglement (time frame: at birth). 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 28 May 2009.