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临床试验/NCT03451838
NCT03451838Unknown不适用

The Prediction of Fetal Macrosomia by Measurement of Placenta Volume and Thickness in Pregnant Women With Diabetes Mellitus

Aljazeera Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年3月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
试验地点
1
主要终点
the number of paticipants who will have babies with macrosomias

研究概览

简要总结

Fetal macrosomia defined as birth weight above 90th centile ,macrosomia occurs in 42-62%of pregnancy complicated by type 1 diabetes mellitus ,in 30-56% of pregnancy complicated by type 2 diabetes mellitus .

-The delivery of macrosomic infant has potentially severe consequence for both the newborn and mother .Increased birth weight increase the risk in the fetus of shoulder dystocia and premature brachial plexus injury ,and those infant weighing above 4500g are at increased risk for neonatal morbidity ,including the need for assisted ventilation and meconium aspiration .Maternal complication result from operative delivery and include postpartum hemorrhage ,third or fourth degree laceration and postpartum infection .

详细描述

Estimated fetal body weight is needed especially when head measurement is impossible whenever the fetal head is positioned low in pelvic brim .A convenient method for estimating fetal body weight without head measurement was thus required .

-The human placenta develop with the principal function of providing nutrients and oxygen to the fetus ,adequate fetal growth and subsequent normal birth weight depend on normal placenta .

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 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 1.Singleton gestational 2.Gestational age over 16-20 weeks 3.Intact membrane 4.Normal umbilical morphology (two arteries and one vein )

排除标准

  • The presence of fetal congenital anomaly .
  • Multifetal pregnancy.
  • Maternal chronic disease (hypertension, renal disease ,and pulmonary disease ,etc.)
  • Patient with a diagnosis such as oligohydramnios ,preeclampsia and intrauterine growth retardation .
  • Patient who used cigarette or alcohol during pregnancy.

结局指标

主要结局

the number of paticipants who will have babies with macrosomias

时间窗: within a week from delivery

To detect number of fetuses who will develop macrosomia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Alalfy

Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Aljazeera Hospital

研究点 (1)

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