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临床试验/NCT04922580
NCT04922580已完成不适用

Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2012年1月1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
700
试验地点
1
主要终点
NICU admission

研究概览

简要总结

Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of meconium staining, low Apgar scores, preterm delivery, and stillbirth.Other predictors such as level of transaminases, history of cholelithiasis, and hepatitis virus infection have been studied but the results are inconclusive.A more comprehensive investigation involving multiple neonatal outcomes and a wide variety of outcome predictors is needed in order to establish guidelines for optimal timing of delivery in pregnancies complicated by ICP. The aim of our study was to evaluate wide variety of predictors of adverse neonatal outcomes in a large cohort of women with ICP .

详细描述

We performed a retrospective cohort study of all women diagnosed with ICP. Pregnancy outcomes including delivery gestational age, spontaneous preterm delivery, iatrogenic preterm delivery, birth weight, mode of delivery, oligohydramnios, intrauterine growth restriction (IUGR), placental abruption, preterm premature rupture of membrane (PPROM), concerning fetal heart tracing, chorioamnionitis, endometritis, postpartum hemorrhage, transfusion, stillbirth, neonatal intensive care unit (NICU) admission, hyperbilirubinemia, meconium stained amniotic fluid, respiratory distress syndrome(RDS) or transient tachypnea of newborn(TTN) (transient tachypnea of the newborn), and composite neonatal outcome were ascertained. A composite adverse neonatal outcome was created and defined as any of the following: NICU admission, hypoglycemia, hyperbilirubinemia, RDS, TTN, mechanical ventilation use, oxygen by nasal cannula, pneumonia, and stillbirth. PPROM was defined by rupture of membrane before 37 weeks gestation. Concerning fetal heart tracing was defined as recurrent variable or late decelerations with moderate variability, prolonged decelerations, or category 3 tracing. Providers who were caring for the women reviewed and independently characterized fetal heart tracings. Since fetal heart tracings were not accessible to authors, authors accepted the providers' interpretation. For analysis of concerning fetal heart tracing, women with non-labor cesarean section were excluded. Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy. Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion. Diagnosis of RDS and TTN were made by the managing neonatologist and based on standard clinical guidelines.

研究设计

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

入排标准

年龄范围
1 Minute 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns were born in maternal and child health hospital of Yong Chuan District from January 2012 to December 2020;②all Newborns' mothers diagnosed intrahepatic cholestasis of pregnancy.

排除标准

  • The newborns were born with severe congenital heart disease and deformities

结局指标

主要结局

NICU admission

时间窗: up to 28 days

Newborns required hospitalization in the NICU after birth

stillbirth

时间窗: up to 1 day

newborns died after birth

Hypoglycemia

时间窗: up to 28 days

Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion

Hyperbilirubinemia

时间窗: up to 28 days

Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy

oxygen by nasal cannula

时间窗: up to 28 days

Newborns required oxygen by nasal cannula

RDS

时间窗: up to 28 days

Newborns were diagnosed with respiratory distress syndrome

pneumonia

时间窗: up to 28 days

Newborns were diagnosed with pneumonia

TTN

时间窗: up to 28 days

Newborns were diagnosed with transient tachypnea of the newborn

mechanical ventilation use

时间窗: up to 28 days

Newborns required mechanical ventilation

次要结局

未报告次要终点

研究者

发起方
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Long,MD

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

研究点 (1)

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