Cervical InsufficiencyTVUSNCT01482039
Patient Attitudes Toward Ultrasound Measurement of Cervical Length
A study testing Sequential ultrasound and Transvaginal ultrasound in people with Cervical Insufficiency, run by Intermountain Women and Children's Research at 1 site in United States.
Trial summary
The investigators propose a prospective evaluation of methods to assess cervical length for uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for routine mid pregnancy ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Insufficiency
- What is being tested?
- Sequential ultrasound and Transvaginal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2012
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- singleton gestation
- between 18-28 weeks
Who cannot join
- presence of cerclage
- known short cervix
- prior preterm birth
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Salt Lake City, Utah, 84177
Stephanie T Romero, MD, 828-301-2711, stephanie.romero@hsc.utah.edu
Stephanie T Romero, MD
About this study
Official title: Patient Attitudes Regarding Abdominal Versus Transvaginal Ultrasonography for Assessment of the Cervical Length in Low Risk Patients: a Randomized Trial
The investigators propose a prospective evaluation of methods to assess cervical length for uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for routine mid pregnancy ultrasound. The investigators hypothesize that a sequential approach to screening of the cervix (which consists of initial transabdominal evaluation first with transvaginal ultrasound reserved only for those patients in whom the cervix appears short on transabdominal exam or when adequate views cannot be obtained with the transabdominal approach alone) will take less time, will result in the same number of adequate views of the cervix and will have higher patient satisfaction that a universal transvaginal screening approach.
OBJECTIVE
Read more
To determine the best strategy for cervical length screening in uncomplicated singleton gestations between the gestational ages of 18-28 weeks.
Primary outcome:
- Time required to obtain adequate views of the cervical length.
Secondary outcomes:
- Patient satisfaction with ultrasound experience as measured by patient questionnaire
- Number of adequate views of the cervix obtained with each approach
STUDY DESIGN
This is a prospective study to compare strategies for cervical length measurements in uncomplicated singleton gestations seen in the MFM office for routine mid pregnancy fetal well being ultrasound between 18-28 weeks gestation. The different strategies include 1) Transabdominal assessment of the cervix (current standard), 2) Sequential evaluation of the cervical length (transabdominal followed by transvaginal if necessary due to short cervix or inadequate transabdominal views), and 3) Transvaginal cervical length assessment. Patients with an uncomplicated singleton gestation presenting for a routine mid pregnancy ultrasound between 18-28 weeks will be randomized into one of the three groups noted above after consent is obtained. Ultrasound examination will then take place and data collected. The various strategies listed above will be compared for the following:
- Time required to obtain views of the cervix
- Time from initiation of exam to completion of cervical assessment
- Time for completion of entire exam
- Patient satisfaction
- Comfort/Discomfort of exam procedure
- Overall impression of exam process
- Number of adequate views of the cervix obtained
Maternal demographics including age, parity, weight, height and due date/gestational age will also be obtained for all consenting patients.
Read the detailed description
BACKGROUND AND SIGNIFICANCE
Preterm birth is a significant problem in the United States and worldwide. Approximately twelve percent of births in the US occur before 37 weeks and are considered preterm. Of these, 80% are considered "spontaneous preterm deliveries" (as opposed to iatrogenic) and are related to preterm labor or preterm rupture of membranes (Arias, 2003). Certain pregnancy characteristics have been identified to determine those patients at risk for preterm delivery. These include a history of preterm birth (Esplin, 2008), uterine anomalies, multiple gestation, among other things, both modifiable and not (Gardosi, 2000; Ananth, 2006). However, an important risk factor that can be identified is the presence of specific changes in the cervix, such as cervical shortening, and in fact, studies indicate that the risk of spontaneous preterm birth increases as cervical length decreases (Iams, 1996; Hibbard, 2000).
Some authors now advocate the universal screening of all pregnant women for cervical shortening at the time of the ultrasound that is performed at 18-28 weeks in most women. However, the best approach to evaluate the cervix in low risk patients (those without an identifiable risk factor) remains controversial.
PROTOCOL
- Patients will be identified in the Maternal Fetal Medicine office and consented for randomization at the time of presentation for previously scheduled mid-trimester ultrasound
- Patients will be given randomly generated treatment allocations within sealed opaque envelopes. Once a patient has consented to enter the trial, the envelope will be opened by the ultrasonographer to determine the assigned treatment regimen.
- Patients will be randomized into one of three groups:
- Standard US evaluation
- Sequential US evaluation
- Transvaginal cervical length screening
- Maternal demographics including maternal age, height, weight, parity, and gestational age will be collected from the patient as part of the patient questionnaire. Ultrasound exam data including measurements of the fetal biometry, presence of fetal anomalies, placental location and amniotic fluid volume will be collected from the official ultrasound report.
- Patients will be assigned a unique study ID number at the time of enrollment and all information including time of ultrasound procedures, clinical data and adequacy of cervical measurement will be linked by the ID number
- All data will be entered into an electronic data base in a de-identified fashion and kept in a secure, encrypted web-based database management program (RedCap).
- Conditions
- Cervical Insufficiency
- Being tested
- Sequential ultrasound, Transvaginal ultrasound
- Keywords
- short cervix, cervical shortening, preterm birth
- Medical subject headings
- Uterine Cervical Incompetence, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential ultrasoundProcedure or surgery
Abdominal ultrasound first; obtain 3 adequate measurements. If 3 adequate views not obtained or if measurement less than 3 cm, perform transvaginal ultrasound for measurement.
Transvaginal ultrasoundProcedure or surgery
Obtain 3 transvaginal ultrasound cervical length measurements
| Study group | Role | What they receive |
|---|---|---|
| Standard Ultrasound | No intervention | Current standard of care - one abdominal view of the cervix to rule out placenta previa |
| Sequential Screen | Experimental | Start with 3 abdominal views of the cervix with measurement. If 3 adequate views cannot be obtained, or if measurement is less than 3cm, then will perform transvaginal scan for measurement. Receives: Procedure: Sequential ultrasound |
| Screening Transvaginal Ultrasound | Experimental | Obtain 3 adequate cervical length measurements using transvaginal ultrasound Receives: Procedure: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
The time it takes to perform the assessment of the cervix will be recorded, as well as the time it takes to perform the entire exam.
Measured: Assessed on the day of ultrasound (one single visit)
Secondary outcomes (2)
Patient satisfaction
Participants will complete a survey indicating their opinions about the ultrasound experience.
Measured: Assessed the day of the ultrasound (one single visit)
Ultrasound adequacy
Assess the frequency with which adequate views of the cervix can be obtained using transabdominal vs transvaginal ultrasonography
Measured: Assessed on the day of the ultrasound (one single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cervical InsufficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Women and Children's Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie T. Romero, Intermountain Women and Children's Research
- Investigators
- Stephanie T Romero, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482039
- Sponsor's protocol ID
- Sonographic Cervical Length
- Acronym
- TVUS
- Status last verified
- Nov 2011
- First submitted
- 25 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Esplin MS, O'Brien E, Fraser A, Kerber RA, Clark E, Simonsen SE, Holmgren C, Mineau GP, Varner MW. Estimating recurrence of spontaneous preterm delivery. Obstet Gynecol. 2008 Sep;112(3):516-23. doi: 10.1097/AOG.0b013e318184181a.
PubMed 18757647Adams MM, Elam-Evans LD, Wilson HG, Gilbertz DA. Rates of and factors associated with recurrence of preterm delivery. JAMA. 2000 Mar 22-29;283(12):1591-6. doi: 10.1001/jama.283.12.1591.
PubMed 10735396Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.
PubMed 8569824Hibbard JU, Tart M, Moawad AH. Cervical length at 16-22 weeks' gestation and risk for preterm delivery. Obstet Gynecol. 2000 Dec;96(6):972-8. doi: 10.1016/s0029-7844(00)01074-7.
PubMed 11084188Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
PubMed 21472815Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815.
PubMed 17671254Stone PR, Chan EH, McCowan LM, Taylor RS, Mitchell JM; SCOPE Consortium. Transabdominal scanning of the cervix at the 20-week morphology scan: comparison with transvaginal cervical measurements in a healthy nulliparous population. Aust N Z J Obstet Gynaecol. 2010 Dec;50(6):523-7. doi: 10.1111/j.1479-828X.2010.01225.x. Epub 2010 Sep 16.
PubMed 21133862
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Attitudes Regarding Abdominal Versus Transvaginal Ultrasonography for Assessment of the Cervical Length in Low Risk Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01482039
- Acronym / sponsor ID
- TVUS / Sonographic Cervical Length
- Conditions
- Cervical Insufficiency
- Keywords
- short cervix, cervical shortening, preterm birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Intermountain Women and Children's ResearchUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 30 Nov 2011 (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 investigators propose a prospective evaluation of methods to assess cervical length for uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for routine mid pregnancy ultrasound. The investigators hypothesize that a sequential approach to screening of the cervix (which consists of initial transabdominal evaluation first with transvaginal ultrasound reserved only for those patients in whom the cervix appears short on transabdominal exam or when adequate views cannot be obtained with the transabdominal approach alone) will take less time, will result in the same number of adequate views of the cervix and will have higher patient satisfaction that a universal transvaginal screening approach.
OBJECTIVE
To determine the best strategy for cervical length screening in uncomplicated singleton gestations between the gestational ages of 18-28 weeks.
Primary outcome:
- Time required to obtain adequate views of the cervical length.
Secondary outcomes:
- Patient satisfaction with ultrasound experience as measured by patient questionnaire
- Number of adequate views of the cervix obtained with each approach
STUDY DESIGN
This is a prospective study to compare strategies for cervical length measurements in uncomplicated singleton gestations seen in the MFM office for routine mid pregnancy fetal well being ultrasound between 18-28 weeks gestation. The different strategies include 1) Transabdominal assessment of the cervix (current standard), 2) Sequential evaluation of the cervical length (transabdominal followed by transvaginal if necessary due to short cervix or inadequate transabdominal views), and 3) Transvaginal cervical length assessment. Patients with an uncomplicated singleton gestation presenting for a routine mid pregnancy ultrasound between 18-28 weeks will be randomized into one of the three groups noted above after consent is obtained. Ultrasound examination will then take place and data collected. The various strategies listed above will be compared for the following:
- Time required to obtain views of the cervix
- Time from initiation of exam to completion of cervical assessment
- Time for completion of entire exam
- Patient satisfaction
- Comfort/Discomfort of exam procedure
- Overall impression of exam process
- Number of adequate views of the cervix obtained
Maternal demographics including age, parity, weight, height and due date/gestational age will also be obtained for all consenting patients.
Detailed description
BACKGROUND AND SIGNIFICANCE
Preterm birth is a significant problem in the United States and worldwide. Approximately twelve percent of births in the US occur before 37 weeks and are considered preterm. Of these, 80% are considered "spontaneous preterm deliveries" (as opposed to iatrogenic) and are related to preterm labor or preterm rupture of membranes (Arias, 2003). Certain pregnancy characteristics have been identified to determine those patients at risk for preterm delivery. These include a history of preterm birth (Esplin, 2008), uterine anomalies, multiple gestation, among other things, both modifiable and not (Gardosi, 2000; Ananth, 2006). However, an important risk factor that can be identified is the presence of specific changes in the cervix, such as cervical shortening, and in fact, studies indicate that the risk of spontaneous preterm birth increases as cervical length decreases (Iams, 1996; Hibbard, 2000).
Some authors now advocate the universal screening of all pregnant women for cervical shortening at the time of the ultrasound that is performed at 18-28 weeks in most women. However, the best approach to evaluate the cervix in low risk patients (those without an identifiable risk factor) remains controversial.
PROTOCOL
- Patients will be identified in the Maternal Fetal Medicine office and consented for randomization at the time of presentation for previously scheduled mid-trimester ultrasound
- Patients will be given randomly generated treatment allocations within sealed opaque envelopes. Once a patient has consented to enter the trial, the envelope will be opened by the ultrasonographer to determine the assigned treatment regimen.
- Patients will be randomized into one of three groups:
- Standard US evaluation
- Sequential US evaluation
- Transvaginal cervical length screening
- Maternal demographics including maternal age, height, weight, parity, and gestational age will be collected from the patient as part of the patient questionnaire. Ultrasound exam data including measurements of the fetal biometry, presence of fetal anomalies, placental location and amniotic fluid volume will be collected from the official ultrasound report.
- Patients will be assigned a unique study ID number at the time of enrollment and all information including time of ultrasound procedures, clinical data and adequacy of cervical measurement will be linked by the ID number
- All data will be entered into an electronic data base in a de-identified fashion and kept in a secure, encrypted web-based database management program (RedCap).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Ultrasound | No intervention | –Current standard of care - one abdominal view of the cervix to rule out placenta previa |
| Sequential Screen | Experimental | Procedure: Sequential ultrasoundStart with 3 abdominal views of the cervix with measurement. If 3 adequate views cannot be obtained, or if measurement is less than 3cm, then will perform transvaginal scan for measurement. |
| Screening Transvaginal Ultrasound | Experimental | Procedure: Transvaginal ultrasoundObtain 3 adequate cervical length measurements using transvaginal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- singleton gestation
- between 18-28 weeks
Key exclusion criteria (3 listed)
- presence of cerclage
- known short cervix
- prior preterm birth
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 |
|---|---|---|
| Sequential ultrasoundAbdominal ultrasound first; obtain 3 adequate measurements. If 3 adequate views not obtained or if measurement less than 3 cm, perform transvaginal ultrasound for measurement. | Procedure or surgery | Sequential Screen |
| Transvaginal ultrasoundObtain 3 transvaginal ultrasound cervical length measurements | Procedure or surgery | Screening Transvaginal Ultrasound |
Primary outcome
Time
Time frame: Assessed on the day of ultrasound (one single visit)
The time it takes to perform the assessment of the cervix will be recorded, as well as the time it takes to perform the entire exam.
2 secondary outcomes
Patient satisfaction
Time frame: Assessed the day of the ultrasound (one single visit)
Ultrasound adequacy
Time frame: Assessed on the day of the ultrasound (one single visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
- Background: PubMed 18757647Esplin MS, O'Brien E, Fraser A, Kerber RA, Clark E, Simonsen SE, Holmgren C, Mineau GP, Varner MW. Estimating recurrence of spontaneous preterm delivery. Obstet Gynecol. 2008 Sep;112(3):516-23. doi: 10.1097/AOG.0b013e318184181a.
- Background: PubMed 10735396Adams MM, Elam-Evans LD, Wilson HG, Gilbertz DA. Rates of and factors associated with recurrence of preterm delivery. JAMA. 2000 Mar 22-29;283(12):1591-6. doi: 10.1001/jama.283.12.1591.
- Background: PubMed 8569824Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.
- Background: PubMed 11084188Hibbard JU, Tart M, Moawad AH. Cervical length at 16-22 weeks' gestation and risk for preterm delivery. Obstet Gynecol. 2000 Dec;96(6):972-8. doi: 10.1016/s0029-7844(00)01074-7.
- Background: PubMed 21472815Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
- Background: PubMed 17671254Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815.
- Background: PubMed 21133862Stone PR, Chan EH, McCowan LM, Taylor RS, Mitchell JM; SCOPE Consortium. Transabdominal scanning of the cervix at the 20-week morphology scan: comparison with transvaginal cervical measurements in a healthy nulliparous population. Aust N Z J Obstet Gynaecol. 2010 Dec;50(6):523-7. doi: 10.1111/j.1479-828X.2010.01225.x. Epub 2010 Sep 16.
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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.
Stephanie T Romero, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential ultrasound and Transvaginal ultrasound in people with Cervical Insufficiency, run by Intermountain Women and Children's Research 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 2 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 30 Nov 2011. 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 Stephanie T Romero, MD (828-301-2711, stephanie.romero@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: Assessed on the day of ultrasound (one single visit)). 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 NCT01482039, which also lists 7 linked publications.
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 30 Nov 2011.