Cervical AssessmentNCT01513395
Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding
A study testing Interval bladder emptying in people with Cervical Assessment and Focal Myometrial Contractions, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound examinations and can impede accurate cervical length measurement and placental location determination. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Assessment, Focal Myometrial Contractions
- What is being tested?
- Interval bladder emptying
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2013
- Phase
- Interventional
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age of 14+0/7 through 31+6/7 weeks
- Presenting for obstetric ultrasound in the MFMU for cervical assessment and/or placental location determination
- Verbal consent
- Ability to refrain from urination for at least 15 minutes
- Age 18 years or greater
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Diana Rodriguez, MD, MPH contact
United States1 site, 1 recruiting
- Recruiting
BIDMC - Dept. of Obstetrics and Gynecology
Boston, Massachusetts, 02215
William T Schnettler, MD, 513-290-0900, wschnett@bidmc.harvard.edu
About this study
Official title: Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding. A Randomized Trial
Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound examinations and can impede accurate cervical length measurement and placental location determination. The timing of bladder voiding is associated with the prevalence of focal myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for cervical assessment compared with no bladder voiding immediately before vaginal ultrasound in order to determine the prevalence of focal myometrial contractions during vaginal ultrasound cervical assessment and test whether timing of bladder voiding is associated with their incidence.
Read the detailed description
This blinded randomized-controlled trial will be performed through the Division of Maternal Fetal Medicine at Beth Israel Deaconess Medical Center. We will offer enrollment to any pregnant woman at gestational weeks 14+0/7 through 31+6/7 presenting for obstetric ultrasound where cervical assessment and/or placental location determination is indicated. Patient positioning and image acquisition will follow a standard protocol and will be performed by the co-investigators. Outcome ascertainment will be performed by two co-investigators blinded to participant allocation upon completion of data collection. Demographic and obstetrical outcome data will be collected via review of the medical record. Analysis of primary and secondary outcomes will yield incidence data, and comparisons will be made between groups.
- Conditions
- Cervical Assessment, Focal Myometrial Contractions
- Being tested
- Interval bladder emptying
- Keywords
- Cervical assessment, Focal myometrial contractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval bladder emptyingBehavioural
Participants randomized to the "Interval" arm (cervical assessment 15 minutes or more after voiding) will be notified of their allocation and asked to immediately use the rest room and attempt to void completely. A synchronized clock will be located in this restroom, and each participant will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. The participant will return to the waiting room or ultrasound room. Any indicated trans-abdominal ultrasound imaging will be performed, and preparations will be made for the vaginal ultrasound. The participant will be asked not to void prior to the vaginal ultrasound. Cervical assessment will take place at a minimum of 15 minutes from voiding time.
| Study group | Role | What they receive |
|---|---|---|
| Immediate | No intervention | Participants randomized to the "Immediate" or control arm (voiding within five minutes of cervical assessment), will undergo any indicated trans-abdominal ultrasound imaging and preparations for vaginal ultrasound (including readying the probe and preparing the exam table for lithotomy position) prior to using the restroom. The participant will be instructed to proceed to the restroom to empty her bladder completely. A synchronized clock will be placed in the restroom, and the patient will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. Vaginal ultrasound and cervical assessment will then be performed immediately upon return to the ultrasound room (within a maximum of 5 minutes from voiding time). |
| Interval | Experimental | Participants randomized to the "Interval" or experimental arm (cervical assessment 15 minutes or more after voiding) will be notified of their allocation and asked to immediately use the rest room and attempt to void completely. A synchronized clock will be located in this restroom, and each participant will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. The participant will return to the waiting room or ultrasound room. Any indicated trans-abdominal ultrasound imaging will be performed, and preparations will be made for the vaginal ultrasound. The participant will be asked not to void prior to the vaginal ultrasound. Cervical assessment will take place at a minimum of 15 minutes from voiding time Receives: Behavioral: Interval bladder emptying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of focal myometrial contraction
Focal myometrial contraction as defined by transvaginal ultrasound findings:
- Thickening of the myometrial portion of the uterine wall visualized as two distinctly different areas of echogenicity
- An unusually long-appearing cervix (possibly more than 50 mm) with an S-shaped endocervical canal and apparent internal os located appreciably cephalad
- Asymmetric anterior and posterior lower uterine segment widths cephalad to apparent internal os
- The thickening is transient.
Measured: Throughout the duration of that ultrasound examination (minutes)
Secondary outcomes (1)
Location of focal myometrial contractions
The location of focal myometrial contractions in relation to the internal cervical os is defined by:
- Distance from internal os to caudal-most portion of focal myometrial contraction (measured with a curved line)..
- Proportion that lie immediately adjacent to the internal cervical os.
Measured: Throughout the duration of that ultrasound examination (minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical AssessmentStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Schnettler, Beth Israel Deaconess Medical Center
- Investigators
- Diana Rodriguez, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513395
- Sponsor's protocol ID
- 2011-P-000425/2 BIDMC
- Status last verified
- Jan 2012
- First submitted
- 17 Jan 2012
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schnettler W, March M, Hacker MR, Modest AM, Rodriguez D. Impaired ultrasonographic cervical assessment after voiding: a randomized controlled trial. Obstet Gynecol. 2013 Apr;121(4):798-804. doi: 10.1097/AOG.0b013e3182860b8d.
PubMed 23635680
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding. A Randomized Trial
- ClinicalTrials.gov ID
- NCT01513395
- Acronym / sponsor ID
- 2011-P-000425/2 BIDMC
- Conditions
- Cervical Assessment, Focal Myometrial Contractions
- Keywords
- Cervical assessment, Focal myometrial contractions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 20 Jan 2012 (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.
Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound examinations and can impede accurate cervical length measurement and placental location determination. The timing of bladder voiding is associated with the prevalence of focal myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for cervical assessment compared with no bladder voiding immediately before vaginal ultrasound in order to determine the prevalence of focal myometrial contractions during vaginal ultrasound cervical assessment and test whether timing of bladder voiding is associated with their incidence.
Detailed description
This blinded randomized-controlled trial will be performed through the Division of Maternal Fetal Medicine at Beth Israel Deaconess Medical Center. We will offer enrollment to any pregnant woman at gestational weeks 14+0/7 through 31+6/7 presenting for obstetric ultrasound where cervical assessment and/or placental location determination is indicated. Patient positioning and image acquisition will follow a standard protocol and will be performed by the co-investigators. Outcome ascertainment will be performed by two co-investigators blinded to participant allocation upon completion of data collection. Demographic and obstetrical outcome data will be collected via review of the medical record. Analysis of primary and secondary outcomes will yield incidence data, and comparisons will be made between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | No intervention | –Participants randomized to the "Immediate" or control arm (voiding within five minutes of cervical assessment), will undergo any indicated trans-abdominal ultrasound imaging and preparations for vaginal ultrasound (including readying the probe and preparing the exam table for lithotomy position) prior to using the restroom. The participant will be instructed to proceed to the restroom to empty her bladder completely. A synchronized clock will be placed in the restroom, and the patient will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. Vaginal ultrasound and cervical assessment will then be performed immediately upon return to the ultrasound room (within a maximum of 5 minutes from voiding time). |
| Interval | Experimental | Behavioral: Interval bladder emptyingParticipants randomized to the "Interval" or experimental arm (cervical assessment 15 minutes or more after voiding) will be notified of their allocation and asked to immediately use the rest room and attempt to void completely. A synchronized clock will be located in this restroom, and each participant will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. The participant will return to the waiting room or ultrasound room. Any indicated trans-abdominal ultrasound imaging will be performed, and preparations will be made for the vaginal ultrasound. The participant will be asked not to void prior to the vaginal ultrasound. Cervical assessment will take place at a minimum of 15 minutes from voiding time |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational age of 14+0/7 through 31+6/7 weeks
- Presenting for obstetric ultrasound in the MFMU for cervical assessment and/or placental location determination
- Verbal consent
- Ability to refrain from urination for at least 15 minutes
- Age 18 years or greater
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Interval bladder emptyingParticipants randomized to the "Interval" arm (cervical assessment 15 minutes or more after voiding) will be notified of their allocation and asked to immediately use the rest room and attempt to void completely. A synchronized clock will be located in this restroom, and each participant will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. The participant will return to the waiting room or ultrasound room. Any indicated trans-abdominal ultrasound imaging will be performed, and preparations will be made for the vaginal ultrasound. The participant will be asked not to void prior to the vaginal ultrasound. Cervical assessment will take place at a minimum of 15 minutes from voiding time. | Behavioural | Interval |
Primary outcome
Presence of focal myometrial contraction
Time frame: Throughout the duration of that ultrasound examination (minutes)
Focal myometrial contraction as defined by transvaginal ultrasound findings: * Thickening of the myometrial portion of the uterine wall visualized as two distinctly different areas of echogenicity * An unusually long-appearing cervix (possibly more than 50 mm) with an S-shaped endocervical canal and apparent internal os located appreciably cephalad * Asymmetric anterior and posterior lower uterine segment widths cephalad to apparent internal os * The thickening is transient.
1 secondary outcome
Location of focal myometrial contractions
Time frame: Throughout the duration of that ultrasound examination (minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
- Derived from this study: PubMed 23635680Schnettler W, March M, Hacker MR, Modest AM, Rodriguez D. Impaired ultrasonographic cervical assessment after voiding: a randomized controlled trial. Obstet Gynecol. 2013 Apr;121(4):798-804. doi: 10.1097/AOG.0b013e3182860b8d.
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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.
Diana Rodriguez, MD, MPH contact
Diana Rodriguez, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval bladder emptying in people with Cervical Assessment and Focal Myometrial Contractions, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 5 inclusion and 1 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 23 Jan 2012. 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 United States. 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 William T Schnettler, MD (513-290-0900, wschnett@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of focal myometrial contraction (time frame: Throughout the duration of that ultrasound examination (minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01513395, which also lists 1 linked publication.
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 23 Jan 2012.