Patient Attitudes Regarding Abdominal Versus Transvaginal Ultrasonography for Assessment of the Cervical Length in Low Risk Patients: a Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Time
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton gestation
- •between 18-28 weeks
排除标准
- •presence of cerclage
- •known short cervix
- •prior preterm birth
结局指标
主要结局
Time
时间窗: 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.
次要结局
- Patient satisfaction(Assessed the day of the ultrasound (one single visit))
- Ultrasound adequacy(Assessed on the day of the ultrasound (one single visit))
研究者
Stephanie T. Romero
Principal Investigator
Intermountain Women and Children's Research