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临床试验/NCT04237142
NCT04237142Unknown不适用

Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
170
试验地点
2
主要终点
PP14 in vaginal secretion at admission

研究概览

简要总结

Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period <48 hours in case of pPROM.

详细描述

Preterm premature rupture of membranes (pPROM) is defined as a spontaneous rupture before the start of labor ("premature" rupture) and before 37 weeks of gestation ("preterm"). pPROM concern 2-3% of pregnancies. It is the main cause of prematurity since it is responsible for 24 to 42% of preterm deliveries. The time between PROM and childbirth is named the latency period. Its total duration can vary from a few hours to several weeks. Childbirth occurs within 48 hours of rupture for 18 to 93% of cases, within 7 days for 56 to 96% and within 28 days for 78 to 100%. The earlier PROM occurs during pregnancy, the longer the latency period is. The factors associated with a shorter latency period are: cervical changes during admission for pPROM, a shortened cervix on ultrasound or a threat of premature delivery prior to PROM, the existence of uterine contractions, oligoamnios, and the occurrence of a materno-fetal complication of pPROM.

In a pPROM situation, a prolonged latency period improves the neonatal prognosis by increasing the gestational age of birth, gives the possibility of administering the corticosteroid treatment of fetal pulmonary maturation and also allows an in utero transfer in an adapted maternity.

Several studies have shown a correlation between the length of the cervix during rupture and the latency period in the context of pPROM.

To date, there are no effective biomarkers used in current practice to predict this latency period.

We want to assess the diagnostic performance of different vaginal (PIBF / PP14 / IGFBP1 native and total) and serum (PIBF / MIF) markers as well as the ultrasound length of the cervix to predict the duration of this latency period in order to better anticipate the risk of prematurity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Results of the biological tests are masked for the clinician and the patient and therefore do not modify the current management. Results will be given after delivery in order to not influence the current medical care of the patient.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week.
  • Capacity to give informed consent.
  • Coverage by a French social security scheme.

排除标准

  • Refusal to participate
  • pPROM formally occurred more than 24 hours ago (free flow or positive breakage test)
  • Cervical dilatation ≥ 4 cm
  • Multiple Pregnancy
  • Known uterine malformation
  • Fetal Malformation
  • Placenta previa
  • Abundant metrorrhagia
  • Patient under guardianship or curatorship

结局指标

主要结局

PP14 in vaginal secretion at admission

时间窗: Day 0

PP14 values in vaginal secretion at admission dosed using the ELISA technique

PIBF in maternal serum at admission

时间窗: Day 0

PIBF values in maternal serum at admission dosed using the ELISA technique

total IGFBP1 in vaginal secretion at admission

时间窗: Day 0

Results of the tests detecting total IGFBP1 (positive/ negative)

PIBF in vaginal secretion at admission

时间窗: Day 0

PIBF values in vaginal secretion at admission dosed using the ELISA technique

native IGFBP1 in vaginal secretion at admission

时间窗: Day 0

Results of the tests detecting native IGFBP1 (positive/ negative)

MIF in maternal serum at admission

时间窗: Day 0

MIF values in maternal serum at admission dosed using the ELISA technique

Ultrasound length of cervix measured at the admission

时间窗: Day 0

Length of cervix was maesured by ultrasound at the admission (millmeters)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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