Cervical Length Measurement Timing for Preterm Birth

Recruiting in Detroit (>99 mi)

Overseen By Raminder Khangura, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Preterm delivery, Cervical insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

550 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 10 11 12}

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.

Research Team

Raminder Khangura, MD

Principal Investigator

Henry Ford Health

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

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

Treatment Details

Interventions

• Cervical Length Measurement

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Findings from Research

In a study of 42 women with singleton pregnancies between 24 to 34 weeks gestation, clinician digital examinations significantly underestimated cervical length (CL) compared to objective measurements using the Cervilenz device, with an average difference of 0.52 cm.

The discrepancy in CL measurements was notable, as 36% of subjects had differences exceeding 1 cm, indicating that the Cervilenz device provides a more accurate assessment for women presenting with symptoms of preterm labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinded comparison of cervical portio length measurements by digital examination vs Cervilenz. Burwick, RM., Lee, GT., Benedict, JL., et al.[2019]

In a study of 216 pregnant women, cervical length measured at 21-24 weeks of gestation was found to be a significant predictor of preterm delivery, while measurements taken at 14-16 weeks were not effective in predicting this outcome.

The change in cervical length between the two measurements did not correlate with the risk of preterm delivery, indicating that monitoring cervical length later in pregnancy is more crucial for assessing the risk of preterm birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can sonographic measurements and changes in cervical length during pregnancy predict preterm labour in an asymptomatic low-risk population? Weitzner, O., Biron-Shental, T., Daykan, Y., et al.[2019]

Ultrasonographic measurement of cervical length is a valuable tool for predicting preterm birth, helping to identify women at risk and potentially reducing rates of prematurity.

The review suggests that appropriate interventions based on cervical length measurements may prevent unnecessary medical procedures and improve outcomes for at-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No. 257-Ultrasonographic Cervical Length Assessment in Predicting Preterm Birth in Singleton Pregnancies. Lim, K., Butt, K., Crane, JM.[2019]

Ultrasonographic measurement of cervical length can effectively predict the risk of preterm birth, helping to identify women who may need closer monitoring or intervention.

Implementing this technique may lead to a reduction in preterm birth rates and prevent unnecessary medical interventions, ultimately improving maternal and fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOGC Clinical Practice Guideline. Ultrasonographic cervical length assessment in predicting preterm birth in singleton pregnancies. Lim, K., Butt, K., Crane, JM.[2017]

In a study of 122 women with threatened preterm labor, a cervical length measurement of less than 15 mm at presentation was found to have high sensitivity (83.3%) and specificity (95.8%) for predicting delivery within one week.

A significant reduction of more than 20% in cervical length within 24 hours also indicated a risk for preterm delivery, but did not enhance prediction accuracy when combined with initial measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of serial cervical length measurements for the prediction of threatened preterm labour. Sotiriadis, A., Kavvadias, A., Papatheodorou, S., et al.[2016]

Transvaginal ultrasonography is a reliable method for assessing cervical length and predicting preterm delivery risk in high-risk pregnancies, with a cervical length of 25 mm or less at 28-30 weeks significantly increasing the risk of preterm delivery.

While cervical length measurement (CLM) is effective in high-risk groups, it has low sensitivity in low-risk populations, and current recommendations suggest using it as a routine method for high-risk pregnancies rather than a general screening tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical length assessment by ultrasound as a predictor of preterm labour--is there a role for routine screening? Hoesli, I., Tercanli, S., Holzgreve, W.[2019]

A systematic review identified 12 articles discussing the effects of transvaginal cervical length measurement in women with symptoms of preterm labor, highlighting potential benefits like patient reassurance, but none quantified these effects.

There is a notable gap in the literature regarding the assessment of additional patient outcomes from cervical length measurements, suggesting that future studies should include comprehensive evaluations of these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional effects of the cervical length measurement in women with preterm contractions: a systematic review. Vis, JY., Kuin, RA., Grobman, WA., et al.[2021]

In a study analyzing 983 cervical length measurements, blinding the operator during mid-trimester scans resulted in a higher prevalence of short cervix (5.5%) compared to non-blinded measurements (2.7%), indicating that observer bias can significantly affect results.

Blinding also led to a more normal distribution of cervical length values, suggesting that it is an effective strategy to enhance the accuracy of cervical length screening for preterm birth risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expected-value bias in mid-trimester preterm birth screening. Aiartzaguena, A., Del Campo, A., Melchor, I., et al.[2022]

In a study of 11,943 women, mid-trimester cervical length (CL) measurements were found to be predictive of spontaneous preterm birth, with likelihood ratios indicating a strong association for very short cervixes (≤ 20 mm) in nulliparous women.

Despite its predictive capacity, the isolated use of CL as a screening tool has limited value due to low sensitivity, with a high number needed to screen (618 for nulliparous and 1417 for low-risk multiparous women) to prevent one case of preterm birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The capacity of mid-pregnancy cervical length to predict preterm birth in low-risk women: a national cohort study. van der Ven, J., van Os, MA., Kazemier, BM., et al.[2016]

In a study of 1,180 low-risk singleton pregnancies, cervical length (CL) measurements taken between 24 and 30 weeks gestation were found to be significantly shorter in women who experienced spontaneous preterm delivery (SPD) between 30-34 weeks and 34-37 weeks, indicating that shorter CL is a strong predictor of early delivery.

The study demonstrated that CL is highly effective in predicting SPD34 with an area under the curve (AUC) of 0.9406, and adequately predicts SPD37 with an AUC of 0.7584, suggesting that monitoring CL can help identify pregnancies at risk for preterm delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of Preterm Delivery by Late Cervical Length Measurement after 24 Weeks. Papastefanou, I., Pilalis, A., Eleftheriades, M., et al.[2016]

In a study of 1113 low-risk women, cervical length (CL) measured at 11-14 weeks showed a small predictive value for preterm delivery (PTD) before 37 weeks, with a sensitivity of only 63.3% and specificity of 51.1%.

However, CL measurements did not predict PTD for deliveries before 35 weeks or 32 weeks, indicating that while there may be some correlation with PTD <37 weeks, it is not a reliable indicator for earlier preterm deliveries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of cervical length measurement at 11-14 weeks for the prediction of preterm delivery. Antsaklis, P., Daskalakis, G., Pilalis, A., et al.[2019]

Sonography-derived cervical length measurements can effectively identify women at increased risk of preterm birth, potentially leading to interventions that may reduce the rates of prematurity.

The review highlights various techniques for measuring cervical length using sonography, emphasizing their clinical utility in managing patients at risk for a short cervix and preterm birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guideline No. 401: Sonographic Cervical Length in Singleton Pregnancies: Techniques and Clinical Applications. Lim, KI., Butt, K., Nevo, O., et al.[2021]

References

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

Blinded comparison of cervical portio length measurements by digital examination vs Cervilenz. [2019]

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]

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

No. 257-Ultrasonographic Cervical Length Assessment in Predicting Preterm Birth in Singleton Pregnancies. [2019]

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

SOGC Clinical Practice Guideline. Ultrasonographic cervical length assessment in predicting preterm birth in singleton pregnancies. [2017]

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

The value of serial cervical length measurements for the prediction of threatened preterm labour. [2016]

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]

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

Additional effects of the cervical length measurement in women with preterm contractions: a systematic review. [2021]

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

Expected-value bias in mid-trimester preterm birth screening. [2022]

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]

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

Prediction of Preterm Delivery by Late Cervical Length Measurement after 24 Weeks. [2016]

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

The role of cervical length measurement at 11-14 weeks for the prediction of preterm delivery. [2019]

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

Guideline No. 401: Sonographic Cervical Length in Singleton Pregnancies: Techniques and Clinical Applications. [2021]