Cervical Length Measurement Timing for Preterm Birth

Recruiting in Palo Alto (17 mi)

Overseen by Raminder Khangura, MD

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Henry Ford Health System

Disqualifiers: Preterm delivery, Cervical insufficiency, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the optimal timing for measuring cervical length (CL) during fetal anatomy surveys in pregnant individuals. This study focuses on improving the accuracy of cervical length assessments, which are critical for identifying individuals at risk for preterm birth. The main questions it aims to answer are: * Does measuring cervical length at the beginning of the anatomy survey result in a higher proportion of scans meeting the nine CLEAR (Cervical Length Education and Review) criteria compared to measuring at the end of the survey? * Does the use of sepia-filtered ultrasound images improve the proportion of scans meeting the nine CLEAR criteria compared to conventional grayscale images? Researchers will compare two groups of participants randomized to have cervical length measured either at the beginning or at the end of the anatomy survey. Additionally, all participants will undergo cervical length measurements using both grayscale and sepia-filtered ultrasound imaging. Participants will: * Receive a patient information sheet through MyChart explaining the study and standard cervical length screening during anatomy surveys. * Provide verbal consent for a transvaginal ultrasound and study participation. * Be randomized to have their cervical length measured at either the start or end of the fetal survey. * Undergo cervical length measurement using both grayscale and sepia-filtered ultrasound imaging modalities. * This study involves no additional risks beyond those of routine clinical care and aims to enhance clinical practice by identifying optimal methods for cervical length assessment during pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on measuring cervical length during pregnancy and does not mention any medication restrictions.

What data supports the effectiveness of the treatment Cervical Length Measurement for preterm birth?

Research shows that measuring cervical length can help predict preterm birth, especially when using ultrasound. This can be useful in identifying women who might benefit from preventive treatments.

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Is cervical length measurement safe for humans?

Cervical length measurement using ultrasound is generally considered safe and is a well-accepted method for assessing the risk of preterm delivery in pregnancies.

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How is cervical length measurement different from other treatments for preventing preterm birth?

Cervical length measurement is unique because it involves using ultrasound to measure the length of the cervix during pregnancy to predict the risk of preterm birth, rather than using medication or physical interventions. This approach focuses on early detection and monitoring rather than direct treatment.

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Eligibility Criteria

This trial is for pregnant individuals undergoing routine fetal anatomy surveys. It's designed to find the best time to measure cervical length, which helps predict preterm birth risk. Participants must consent to a transvaginal ultrasound and be okay with being randomly assigned when their cervical length will be measured.

Inclusion Criteria

Agreement to participate in the study, including randomization for the timing of cervical length measurement

Presenting for a fetal anatomy survey at Henry Ford Health MFM ultrasound units

Consent to a transvaginal cervical length measurement as part of routine care

Exclusion Criteria

Patients receiving care at non-Henry Ford Health radiology clinics

History of preterm delivery

Declines or unable to consent to a transvaginal cervical length measurement

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Randomization and Intervention

Participants are randomized to have cervical length measured at either the start or end of the anatomy survey using both grayscale and sepia-filtered ultrasound imaging.

1 day

1 visit (in-person)

Data Collection and Analysis

Cervical length measurements are collected and analyzed for adherence to the nine CLEAR criteria.

1-2 weeks

Follow-up

Participants are monitored for any adverse effects and the study outcomes are evaluated.

4 weeks

Participant Groups

The study tests whether measuring cervical length at the start or end of an anatomy survey affects its accuracy, using both grayscale and sepia-filtered ultrasound images. The goal is to determine if timing and imaging method can improve detection of potential preterm births.

Group I: End of Anatomy Survey Experimental Treatment 1 Intervention

Participants in this arm will undergo cervical length measurement via transvaginal ultrasound at the end of the fetal anatomy survey. This timing aims to evaluate whether late measurement improves adherence to the nine CLEAR criteria for accurate cervical length assessment. Measurements will also be conducted using grayscale and sepia-filtered ultrasound imaging.

Group II: Beginning of Anatomy Survey Experimental Treatment 1 Intervention

Participants in this arm will undergo cervical length measurement via transvaginal ultrasound at the start of the fetal anatomy survey. This timing aims to evaluate whether early measurement improves adherence to the nine CLEAR criteria for accurate cervical length assessment. Measurements will also be conducted using grayscale and sepia-filtered ultrasound imaging.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Henry Ford Health New Center One Detroit, MI

Who Is Running the Clinical Trial?

Henry Ford Health System Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Blinded comparison of cervical portio length measurements by digital examination vs Cervilenz. [2019] Cervical length (CL) examinations may identify patients in preterm labor or those who may benefit from prophylactic therapy. We sought to compare the accuracy of clinician digital CL examinations with objective measurements using the Cervilenz device in women presenting with symptoms of preterm labor.

2. England pubmed.ncbi.nlm.nih.gov

Can sonographic measurements and changes in cervical length during pregnancy predict preterm labour in an asymptomatic low-risk population? [2019] This study measured cervical length (CL) at 14-16 and 21-24 weeks of gestation and assessed whether the difference between the measurements is predictive of preterm delivery (PTD).

3. Netherlands pubmed.ncbi.nlm.nih.gov

No. 257-Ultrasonographic Cervical Length Assessment in Predicting Preterm Birth in Singleton Pregnancies. [2019] To review (1) the use of ultrasonographic-derived cervical length measurement in predicting preterm birth and (2) interventions associated with a short cervical length.

4. Netherlands pubmed.ncbi.nlm.nih.gov

SOGC Clinical Practice Guideline. Ultrasonographic cervical length assessment in predicting preterm birth in singleton pregnancies. [2017] To review (1) the use of ultrasonographic-derived cervical length measurement in predicting preterm birth and (2) interventions associated with a short cervical length.

5. Ireland pubmed.ncbi.nlm.nih.gov

The value of serial cervical length measurements for the prediction of threatened preterm labour. [2016] To assess the predictive performance of cervical length measurement at presentation and 24h later in women with symptoms of preterm labour.

6. England pubmed.ncbi.nlm.nih.gov

Cervical length assessment by ultrasound as a predictor of preterm labour--is there a role for routine screening? [2019] Transvaginal ultrasonography has recently been shown to be an objective, reproducible and reliable method to assess the cervix and predict the risk of preterm delivery in high-risk pregnancies. Assessment of the cervix includes cervical length measurement (CLM) and measurement of dilatation of the internal os in a dynamic functional examination. There is an inverse correlation between cervical length and the frequency of preterm delivery. The high negative predictive value avoids unnecessary interventions such as tocolysis or cerclage in high-risk pregnancies. In contrast, a length of 25 mm or less at 28-30 weeks of gestation is associated with a significantly increased incidence of preterm delivery. Studies in women with high risk for preterm delivery, i.e. contractions, premature rupture of the membranes and history of preterm delivery, have shown a high sensitivity and a high positive predictive value, however in low-risk groups they have failed to show a high sensitivity. From large observational studies in low-risk populations we know that the 50th percentile of the cervical length is 35 mm at 24 weeks of gestation. Advantages of CLM as a screening test include the fact that sonographical assessment of the cervix is a widely accepted and well-standardised method, which requires only a relatively short period of training. Disadvantages of screening are two factors, the first being the low sensitivity of the test and the low prevalence of preterm deliveries in a low-risk population, resulting in cut off values being set at a very low level (i.e. 5th percentile) in order to get acceptable specificity. Secondly, screening is only worthwhile if an effective preventive therapy is available. The debate about tocolysis and cerclage is not yet concluded. Therefore we would not currently recommend cervical length measurement as a screening tool-but as a routine method in high risk gravidas with or without symptoms. Further interest should be focused on scoring systems combining ultrasound with biochemical, endocrinological and maybe molecular cell methods such as the measurement of fetal DNA in maternal blood to prevent preterm deliveries in the general population.

7. Germany pubmed.ncbi.nlm.nih.gov

Additional effects of the cervical length measurement in women with preterm contractions: a systematic review. [2021] Transvaginal cervical length measurement in women with symptoms of preterm labor has been used to decide if treatment is necessary. Cervical length measurement may also have additional effects on patients, such as providing reassurance, although the evidence to support this is unclear. We explored and summarized to what extent additional effects of cervical length measurement in women with threatened preterm labor have been reported in the clinical literature and what the magnitude of these effects was.

8. England pubmed.ncbi.nlm.nih.gov

Expected-value bias in mid-trimester preterm birth screening. [2022] Cervical length (CL) measurement ≤ 25 mm on mid-trimester ultrasound scan is a known risk factor for preterm birth, for which vaginal progesterone is recommended. The aims of this study were to evaluate whether CL measurement is affected by observer bias and to assess the impact on short cervix prevalence of masking CL measurement during routine mid-trimester ultrasound scan.

9. United States pubmed.ncbi.nlm.nih.gov

The capacity of mid-pregnancy cervical length to predict preterm birth in low-risk women: a national cohort study. [2016] We investigated the predictive capacity of mid-trimester cervical length (CL) measurement for spontaneous and iatrogenic preterm birth.

10. Switzerland pubmed.ncbi.nlm.nih.gov

Prediction of Preterm Delivery by Late Cervical Length Measurement after 24 Weeks. [2016] To examine the value of the cervical length (CL) measurement at 24-30 gestational weeks in the prediction of spontaneous preterm delivery (SPD) between 30 and 34 weeks (SPD34) and between 34 and 37 weeks (SPD37).

11. England pubmed.ncbi.nlm.nih.gov

The role of cervical length measurement at 11-14 weeks for the prediction of preterm delivery. [2019] To determine whether cervical length (CL) measurement at 11?14 weeks is predictive of preterm delivery (PTD).

12. Netherlands pubmed.ncbi.nlm.nih.gov

Guideline No. 401: Sonographic Cervical Length in Singleton Pregnancies: Techniques and Clinical Applications. [2021] • To assess the association between sonography-derived cervical length measurement and preterm birth. • To describe the various techniques to measure cervical length using sonography. • To review the natural history of the short cervix. • To review the clinical uses, predictive ability, and utility of sonography-measured short cervix.