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临床试验/NCT03321435
NCT03321435已完成不适用

The Effect of Placenta Previa on Fetal Weight and Feto-maternal Blood Flow

Assiut University0 个研究点目标入组 200 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
Estimated fetal wight (gram)

研究概览

简要总结

Placenta previa is a placenta that implants at lower uterine segment, it occurs in about 0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this abnormal placenta has a negative concern about fetal well being due to prematurity and perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to the lower uterine segment is less than at the upper segment apparently resulting in less feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa may affect fetal oxygenation and fetal growth.

In spite of above evidences; many studies in literature denied the relation between placenta previa and fetal growth and concluded that the association between low birth weight and placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth restriction. However; the major drawback of all these studies is lacking of reporting the effect of placenta previa of feto-maternal blood flow representing in studying of Doppler blood flow in both uterine and umbilical artery in those patients. The uterine artery blood flow is usually affected by the presence of placenta previa and placenta accreta which reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful tool for predicting placenta accreta .

So in the light of above evidences; we aimed, in the current study, not only to investigate the effect on placenta previa on fetal weight but also to walk around the effect of placenta previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting issue. To our knowledge, no previous trial had studied this interesting subject before.

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
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are sure of her pregnancy.
  • Women aged 20-35 years.
  • Women with BMI 18-22 kg/m
  • Estimated gestational age is ranging between 30- 32 weeks gestation.
  • Singleton pregnancy.
  • Placenta previa; either major or minor degrees as regard the cases.
  • Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
  • Women with normal Doppler indices in uterine and umbilical arteries at time of recruitment.
  • Women should be living in a nearby area to make follow-up and early transportation are reasonably possible.

排除标准

  • Women aged < 20 and >35 years.
  • Smoker ≥ 11 cigarettes/day.
  • Severe attack of bleeding requiring an immediate intervention.
  • Fetal heart rates instability or non reassuring.
  • Multiple gestations.
  • Previous Intrauterine growth restricted fetus.
  • Intrauterine fetal death or major fetal anomalies.
  • If associated with abruptio placentae.
  • Patients with known bleeding disorders or on anticoagulant therapy

结局指标

主要结局

Estimated fetal wight (gram)

时间窗: 4 weeks

次要结局

  • The value of Doppler indices in uterine artery(4 weeks)

研究者

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

Mohammed Khairy Ali

Lecturer

Assiut University

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