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临床试验/NCT05044143
NCT05044143已完成不适用

Serial Cervical Length Measurements After the 1st Episode of Threatened Preterm Labor to Improve Prediction of Spontaneous Preterm Delivery: Prospective Cohort Study

University of Modena and Reggio Emilia12 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
303
试验地点
12
主要终点
To investigate the association between cervical length measured at different time points and the risk of spontaneous preterm birth < 37 weeks' gestation

研究概览

简要总结

Prospective cohort study on pregnant women discharged from the hospital after the first episode of threatened preterm labor. Cervical length (CL) will be measured with transvaginal US upon initial presentation (i.e at the time of hospital admission), at the time of hospital discharge, and respectively 2, 4, 8 and 12 weeks later. Pregnant women undelivered after the 1st episode of threatened preterm labor will be invited to participate in the study if CL upon discharge is < 25 mm. The study will investigate the potential association between cervical shortening over time and time of delivery, to assess if spontaneous preterm delivery can be predicted by CL.

详细描述

Preterm labor is the result of labor occurring prior to 36 6/7 weeks' gestation (i.e spontaneous preterm labor) leading to delivery. Preterm labor is a clinical diagnosis, defined as the appearance of regular contractions accompanied by a change in cervical dilation, effacement, or both, or initial presentation with regular contractions and cervical dilation of at least 2 cm prior to 36 6/7 weeks' gestation.

The pathogenesis of preterm labor has not yet been fully understood, but it has been hypothesized that it could be caused by early idiopathic activation of the normal process of labor or instead, that it could be the result of pathological insults (Goldenberg 2008, Hamilton 2013, Slattery 2002). In Western countries, spontaneous PTB is responsible for 75% of perinatal mortality and more than half of long-term morbidity (McCormick 1985). Although most preterm newborns survive, they have an increased risk of neuro-behavioral disability, cerebral palsy, mental and developmental retardation. Moreover, spontaneous PTB also represents an important cause of chronic broncho pneumopathies, visual and auditory abnormalities and other chronic diseases of the pediatric age including school failure.

As contractions are the most commonly recognized antecedent of preterm birth, cessation of uterine contractions has been the primary focus of therapeutic intervention to prevent the burden of prematurity.

Preterm labor is currently considered a syndrome with a multifactorial etiology, among which inflammation, uteroplacental ischemia or hemorrhage, uterine overdistension, stress and other immune-mediated processes certainly play a role (Romero 2006): these factors do not necessarily represent a direct cause, but contribute to a transition from uterine quiescence to preterm labor or preterm premature rupture of membranes (pPROM) (Goldenberg 2005).

There are many maternal and fetal conditions that have been associated with PTB, including maternal demographic characteristics (such as low socio-economic status, race), nutritional status, obstetric history (history of prior spontaneous PTB), psychological aspects, risk behaviors (such as drug and tobacco use), infections, short CL, as well as biological and genetic markers (Goldenberg 2008, Andrews 2000).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy at 23+0 - 33+6 weeks' gestation
  • Age > 18 years old
  • Patients should be capable of providing consent to participate in the study

排除标准

  • Previous spontaneous preterm (20+0 - 36+6 weeks' gestation) delivery (including history of pregnancy loss due to cervical incompetence, i.e painless cervical dilatation prior to 24 weeks' gestation)
  • Treatment with 17 hydroxyprogesterone caproate due to a previous spontaneous preterm delivery
  • Detection of a cervical length < 25 mm during routine ultrasound < 24 weeks' gestation in asymptomatic patients (i.e patients that do not complain of uterine contractions or patients with no uterine contractions documented on tocometry)
  • Treatment with vaginal progesterone or micronized progesterone due to a cervical length < 25 mm
  • Cerclace placement in the current or in a previous pregnancy
  • Multiple pregnancy
  • Age < 18 years old
  • Preterm premature rupture of membranes (pPROM) upon initial presentation
  • Müllerian malformations
  • Prior cervical surgery

结局指标

主要结局

To investigate the association between cervical length measured at different time points and the risk of spontaneous preterm birth < 37 weeks' gestation

时间窗: At the time of delivery

The risk of spontaneous preterm birth \< 37 weeks' gestation will be compared among women with at least a cervical length \< 10 mm as opposed to those whose cervix will remain persistently \> 10 mm. A relationship between gestational age at delivery and cervical length will also be investigate considering the two variables as continuous

次要结局

  • To assess a possible association between cervical length and adverse neonatal outcomes(At the time of delivery)
  • To assess a possible association between cervical length and adverse maternal outcomes.(At the time of delivery)

研究者

发起方
University of Modena and Reggio Emilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Chiossi

Attending Physician, Department of Obstetrics and Gynecology

University of Modena and Reggio Emilia

研究点 (12)

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