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临床试验/NCT03208842
NCT03208842Unknown不适用

Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar With Doppler Assessment of Retro Chorionic Blood Flow

Cairo University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Placenta previa

研究概览

简要总结

After gaining verbal consent , Patients included in this study will be subjected to:

  1. history taking :
  • peronal history .
  • obstetric history.
  • past history
  1. general examination including vital signs

  2. abominal and pelvic examination

  3. the patient will be examined son graphically at 3 visits

  4. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):

  5. anterior,

  6. posterior,

  7. Fundal,

  8. low-lying anterior,\

  9. low lying posterior We adopted the definition of implantation site from previous publication (Abdallah et al., 2012). The implantation site is visualized in the sagittal plane as a hyperechoic ring that occupies one side of the implanted gestational sac and protrudes into the endometrial lumen It represents the maternal decidual reaction and the beginning of maternal-fetal circulation. This area is also believed to be responsible for future placental formation and development (Brosens and Gellersen, 2010) Distance between the implantation site and the internal cervical ostium (os). This was taken from the lower end of the hyperechoic trophoblast ring of the gestational sac to the internal cervical os in the sagittal plane.

  • doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
  1. then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery

详细描述

After gaining verbal consent , Patients included in this study will be subjected to:

  1. history taking :
  • peronal history .
  • obstetric history.
  • past history
  1. general examination including vital signs

  2. abominal and pelvic examination

  3. the patient will be examined son graphically at 3 visits

  4. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):

  5. anterior,

  6. posterior,

  7. Fundal,

  8. low-lying anterior,\

  9. low lying posterior

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton intrauterine pregnancy.
  • gestational age less than 10 weeks
  • history of previous cesarean section(one or more)

排除标准

  • negative fetal pole pulsation.
  • any condition distorting uterine cavity i.e uterine myoma,uterine cavity anomalies
  • multifetal pregnancy.
  • any condition necessitate termination of early pregnancy i.e maternal medical disorder ,molar pregnancy.

结局指标

主要结局

Placenta previa

时间窗: at 36 weeks of gestational age

measuring the distance between lower placental edge and internal os of the cervix by ultrasound

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

Ahmed Maged

Professor

Cairo University

研究点 (1)

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