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临床试验/NCT05802251
NCT05802251招募中不适用

Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
1
主要终点
maternal bleeding rate

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa.

详细描述

The incidence of placenta previa is 3-5 per 1000 pregnancies worldwide and is still rising because of increased maternal age, parity, cesarean section rates, assisted reproductive technology, maternal smoking with the widespread use of transvaginal ultrasound. antepartum hemorrhage is an important cause of maternal and neonatal morbidity and mortality in pregnant women with placenta previa. However, the epidemiological characteristics are not completely understood. this study aims at evaluating the sonographic findings in asymptomatic women with placenta previa as cervical length, placenta thickness and distance from cervix to placental edge to recommend management for in-patients versus out-patient antenatal care and early planned hospital admission and delivery for women at high risk of antepartum hemorrhage and preterm cesarean section and hysterectomy for life threatening antepartum hemorrhage.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Asymptomatic women diagnosed with placenta previa according to RCOG (GTG No. 27a, 2018): placenta lies directly over the internal os for pregnancies more than 16 weeks' gestation on transabdominal or transvaginal scanning.
  • Gestational age between 28 till 37 weeks' gestation (as delivery should be considered between 36 and 37 weeks of gestation for women presenting with uncomplicated placenta previa)

排除标准

  • Multiple pregnancies.
  • Threatened preterm labor or preterm rupture of membranes.
  • History of bleeding in the current pregnancy.
  • Polyhydraminos (AFI > 25 cm).
  • History of cervical surgery (cone biopsy).
  • Presence of cervical cerclage.
  • Maternal use of vaginla progesterone.
  • History of maternal disease (hypertensive, DM, Cardiac).
  • Fetal malformation or growth restriction

结局指标

主要结局

maternal bleeding rate

时间窗: till delivery

number of attacks of antepartum hemorrhage

次要结局

  • Emergency Cesarean section(till delivery 36 to 37 weeks)
  • Blood transfusion(till delivery 36 to 37 weeks)
  • Premature delivery(37 week's gestation)
  • Postpartum hemorrhage(Within 2 hours of delivery)
  • Need for cesarean hysterectomy(during cesarean section)

研究者

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

Maya Abdelrazek

Lecturer

Ain Shams University

研究点 (1)

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