Cervical DilationNCT05038891
Self-Obtained Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor
An observational study of Cervical Dilation, run by Mayo Clinic at 2 sites in United States.
Trial summary
This is a pilot study to test the accuracy and comfort of self-directed ultrasound imaging of cervical dilation and effacement in pregnant women undergoing induction of labor. The study will assess correlation of cervical measurements between self-directed imaging and experienced provider digital cervical examinations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dilation
- What is being tested?
- Digital Cervical Exam, Transperineal Ultrasound and Transvaginal Ultrasound
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2021to 1 Dec 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This pilot study will enroll pregnant women undergoing induction of labor at the Family Birth Center at Mayo Clinic Hospital in Rochester, MN. The target population will include women with a singleton fetus at gestational age greater than 28 weeks 0 days gestation who have intact membrane status at time of induction of labor.
Who may be able to join
- Pregnant females age 18 years or older
- Third trimester of pregnancy with a singleton fetus (gestational age >28 weeks)
- Pre-gestational body mass index <40
- Scheduled for induction of labor
- Eligible for induction of labor based on current birth center guidelines
- Intact membranes when presenting for induction of labor
Who cannot join
- History of prior cervical loop electrosurgical excisional procedure or cold knife conization
- Cerclage placement during current pregnancy
- Positive COVID-19 test within 7 days of admission for induction of labor
- Fever > 38.0 C at time of admission for induction of labor
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic Methodist Hospital
Rochester, Minnesota, 55929
About this study
Official title: Self-Obtained Transperineal and Transvaginal Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor: Implications for Telemedicine and Home Hospital in Obstetrics
This is a pilot study to test the accuracy and comfort of self-directed ultrasound imaging of cervical dilation and effacement in pregnant women undergoing induction of labor. The study will assess correlation of cervical measurements between self-directed imaging and experienced provider digital cervical examinations.
Read the detailed description
The primary objective will assess correlation of cervical measurements with gold standard of provider digital cervical examinations and self-obtained transperineal and transvaginal images. Experienced providers performing digital cervical examinations will be blinded to ultrasound images and measurements. The maternal-fetal medicine subspecialist interpreting the ultrasound images will be blinded to patient details and will document ultrasound measurement of cervical dilation of the internal cervical os as the mean of anterior-posterior and transverse measurements and cervical length. 2-D ultrasound images and cine clips will be obtained at up to five different time points during the induction of labor.
As as secondary objective, participant discomfort and anxiety will be measured following the initial set of cervical measurements using the Visual Analog Scale and Six-Item State-Trait Anxiety Inventory.
- Conditions
- Cervical Dilation
- Being tested
- Digital Cervical Exam, Transperineal Ultrasound, Transvaginal Ultrasound
- Keywords
- Cervical Effacement, Cervical Dilation, Labor, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cervical ExamDiagnostic test
Standard Digital Cervical Exam by an experienced OB provider
Transperineal UltrasoundDiagnostic test
Self-administered transperineal ultrasound after instruction by a health care professional
Transvaginal UltrasoundDiagnostic test
Self-administered transvaginal ultrasound after instruction by a health care professional
| Study group | Role | What they receive |
|---|---|---|
| Digital Cervical Assessment performed first | A digital cervical exam will be performed by an experienced senior obstetrics and gynecology resident, using index finger and middle finger to measure the dilation and thickness of the cervix. This is the gold standard measurement utilized to assess the labor course. In this group, the digital cervical exam is done first, followed by a participant-performed ultrasound imaging assessment of the cervix. Receives: Diagnostic Test: Digital Cervical Exam; Diagnostic Test: Transperineal Ultrasound; Diagnostic Test: Transvaginal Ultrasound | |
| Ultrasound Assessment performed first | Ultrasound imaging will be first taught by an experienced RN, then self-performed by the participant in the presence of junior obstetrics and gynecology resident and the RN. The junior resident will ensure the ultrasound device is functioning properly and the images are saved. In this group, the participant-performed imaging assessment is done first, followed by a digital cervical exam performed by an experienced senior obstetrics and gynecology resident. Receives: Diagnostic Test: Digital Cervical Exam; Diagnostic Test: Transperineal Ultrasound; Diagnostic Test: Transvaginal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.
Data collection will occur at up to five time points along a participant's labor course. Providers will be blinded to ultrasound images. Data includes provider digital exam, transperineal ultrasound cine clip with mean (anterior-posterior and transverse) measurement of internal os and total cervical length and transvaginal ultrasound cine clips with mean (anterior-posterior and transverse) measurement of internal os and total cervical length. Ultrasound images will be read by maternal-fetal medicine subspecialist blinded to patient information, labor stage and provider cervical examination.
Measured: Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months
Secondary outcomes (2)
Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)
The Visual Analog Scale values range from 0 to 10 where higher values indicate more pain and will be assessed once after the first cervical examination.
Measured: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)
The 6 items which are on a 4 point likert scale will be administered to participants post first cervical exam. The 6 items are summed, divided by 6 and hen multiplied by 20 to give a range of 20 to 80. Higher scores indicate more anxiety.
Measured: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start13 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DilationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regan N. Theiler, Mayo Clinic
- Investigators
- Regan N Theiler, M.D., Principal investigator, Mayo ClinicMegan Miller, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038891
- Sponsor's protocol ID
- 21-004735
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Obtained Transperineal and Transvaginal Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor: Implications for Telemedicine and Home Hospital in Obstetrics
- ClinicalTrials.gov ID
- NCT05038891
- Acronym / sponsor ID
- 21-004735
- Conditions
- Cervical Dilation
- Keywords
- Cervical Effacement, Cervical Dilation, Labor, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- 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.
This is a pilot study to test the accuracy and comfort of self-directed ultrasound imaging of cervical dilation and effacement in pregnant women undergoing induction of labor. The study will assess correlation of cervical measurements between self-directed imaging and experienced provider digital cervical examinations.
Detailed description
The primary objective will assess correlation of cervical measurements with gold standard of provider digital cervical examinations and self-obtained transperineal and transvaginal images. Experienced providers performing digital cervical examinations will be blinded to ultrasound images and measurements. The maternal-fetal medicine subspecialist interpreting the ultrasound images will be blinded to patient details and will document ultrasound measurement of cervical dilation of the internal cervical os as the mean of anterior-posterior and transverse measurements and cervical length. 2-D ultrasound images and cine clips will be obtained at up to five different time points during the induction of labor.
As as secondary objective, participant discomfort and anxiety will be measured following the initial set of cervical measurements using the Visual Analog Scale and Six-Item State-Trait Anxiety Inventory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Cervical Assessment performed first | – | Diagnostic Test: Digital Cervical Exam, Diagnostic Test: Transperineal Ultrasound, Diagnostic Test: Transvaginal UltrasoundA digital cervical exam will be performed by an experienced senior obstetrics and gynecology resident, using index finger and middle finger to measure the dilation and thickness of the cervix. This is the gold standard measurement utilized to assess the labor course. In this group, the digital cervical exam is done first, followed by a participant-performed ultrasound imaging assessment of the cervix. |
| Ultrasound Assessment performed first | – | Diagnostic Test: Digital Cervical Exam, Diagnostic Test: Transperineal Ultrasound, Diagnostic Test: Transvaginal UltrasoundUltrasound imaging will be first taught by an experienced RN, then self-performed by the participant in the presence of junior obstetrics and gynecology resident and the RN. The junior resident will ensure the ultrasound device is functioning properly and the images are saved. In this group, the participant-performed imaging assessment is done first, followed by a digital cervical exam performed by an experienced senior obstetrics and gynecology resident. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This pilot study will enroll pregnant women undergoing induction of labor at the Family Birth Center at Mayo Clinic Hospital in Rochester, MN. The target population will include women with a singleton fetus at gestational age greater than 28 weeks 0 days gestation who have intact membrane status at time of induction of labor.
Key inclusion criteria (6 listed)
- Pregnant females age 18 years or older
- Third trimester of pregnancy with a singleton fetus (gestational age >28 weeks)
- Pre-gestational body mass index <40
- Scheduled for induction of labor
- Eligible for induction of labor based on current birth center guidelines
Key exclusion criteria (4 listed)
- History of prior cervical loop electrosurgical excisional procedure or cold knife conization
- Cerclage placement during current pregnancy
- Positive COVID-19 test within 7 days of admission for induction of labor
- Fever > 38.0 C at time of admission for induction of labor
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 |
|---|---|---|
| Digital Cervical ExamStandard Digital Cervical Exam by an experienced OB provider | Diagnostic test | Digital Cervical Assessment performed first, Ultrasound Assessment performed first |
| Transperineal UltrasoundSelf-administered transperineal ultrasound after instruction by a health care professional | Diagnostic test | Digital Cervical Assessment performed first, Ultrasound Assessment performed first |
| Transvaginal UltrasoundSelf-administered transvaginal ultrasound after instruction by a health care professional | Diagnostic test | Digital Cervical Assessment performed first, Ultrasound Assessment performed first |
Primary outcome
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.
Time frame: Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months
Data collection will occur at up to five time points along a participant's labor course. Providers will be blinded to ultrasound images. Data includes provider digital exam, transperineal ultrasound cine clip with mean (anterior-posterior and transverse) measurement of internal os and total cervical length and transvaginal ultrasound cine clips with mean (anterior-posterior and transverse) measurement of internal os and total cervical length. Ultrasound images will be read by maternal-fetal medicine subspecialist blinded to patient information, labor stage and provider cervical examination.
2 secondary outcomes
Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)
Time frame: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)
Time frame: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
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 11 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cervical Dilation
Not yet recruitingObservational study
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RecruitingPhase 2/3
Anticholinergics for Cervical Edema in Labor
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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.
Regan N Theiler, M.D. principal investigator
Mayo Clinic
Megan Miller, M.D. study chair
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dilation, run by Mayo Clinic at 2 sites 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 6 inclusion and 4 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam. (time frame: Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months). 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 11 Apr 2024.