Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Proportion of Cervical Length Measurements Meeting CLEAR Criteria at time of anatomy scan, between 18-24 weeks gestation, measured by transvaginal ultrasound
研究概览
简要总结
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.
详细描述
Study Title: Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey
Study Aim and Background: This randomized controlled trial investigates whether the timing of cervical length measurements during fetal anatomy surveys impacts the accuracy of assessments. Current guidelines recommend transvaginal cervical length screening during anatomy surveys to identify individuals at risk for preterm birth. However, the guidelines do not specify whether measurements should be taken at the beginning or end of the ultrasound exam, a lengthy procedure (60-90 minutes) that may introduce uterine contractions and distort results. Additionally, the study evaluates whether using sepia-filtered ultrasound images can enhance measurement accuracy compared to conventional grayscale imaging.
Primary Hypothesis: Cervical lengths measured at the beginning of the fetal survey will result in a higher proportion of scans meeting the nine CLEAR criteria than those measured at the end.
Secondary Hypothesis: Sepia-filtered ultrasound imaging will yield a greater proportion of scans meeting the CLEAR criteria compared to grayscale imaging.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No additional masking is used as this is an open-label study.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant individuals between 16 weeks and 23 weeks + 6 days of gestation.
- •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.
- •Agreement to participate in the study, including randomization for the timing of cervical length measurement.
排除标准
- •History of preterm delivery.
- •Diagnosis of cervical insufficiency.
- •Declines or unable to consent to a transvaginal cervical length measurement.
- •Patients receiving care at non-Henry Ford Health radiology clinics.
研究组 & 干预措施
Beginning of Anatomy Survey
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.
干预措施: Cervical Length Measurement at the Beginning of the Anatomy Survey (Procedure)
End of Anatomy Survey
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.
干预措施: Cervical Length Measurement at the End of the Anatomy Survey (Procedure)
结局指标
主要结局
Proportion of Cervical Length Measurements Meeting CLEAR Criteria at time of anatomy scan, between 18-24 weeks gestation, measured by transvaginal ultrasound
时间窗: At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).
The primary outcome is the proportion of transvaginal cervical length measurements that meet all nine CLEAR (Cervical Length Education and Review) criteria for accuracy. This will assess whether timing (beginning vs. end of anatomy survey) impacts measurement reliability.
次要结局
- Proportion of Scans Meeting CLEAR Criteria Using Sepia-Filtered Imaging(At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).)
研究者
Raminder Khangura
Principal Investigator
Henry Ford Health System