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临床试验/NCT03130504
NCT03130504已完成2 期

The Use Of Intramuscular Hydroxyprogesterone Caproate For Management Of Placenta Previa Before 34 Weeks Of Gestation

Assiut University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
130
试验地点
1
主要终点
number of women delivered before 37 weeks

研究概览

简要总结

Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide.

Placenta previa is a placenta inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal mortality of 8.1% in the developed world and much more in developing countries.

Many studies in literature proved the positive correlation between the Placenta previa and preterm uterine contractility and also reported that large proportion of women who have Placenta previa associated with vaginal bleeding will have subclinical uterine contractions before the onset of evident vaginal bleeding.

There are many tocolytic agents may have a role in conservative management of Placenta previa such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized placebo-controlled trial found a significant reduction in recurrent preterm birth before 37 weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus 54.9%).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Estimated gestational age is ranging between 24 weeks and 26 week's gestation
  • Singleton pregnancy.
  • Placenta previa; either major or minor degrees.
  • Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
  • For outpatient follow ups, women should be living in a nearby area to make follow-up and early transportation are reasonably possible.
  • Accepting to participate in the study.

排除标准

  • Definite rupture of membranes.
  • Established preterm labor.
  • Severe attack of bleeding requiring an immediate intervention.
  • Fetal heart rates instability or non reassuring
  • Intrauterine fetal death or major fetal anomalies.
  • If associated with abruptio placentae
  • Patients with known bleeding disorders or on anticoagulant therapy
  • Patents with severe medical disorders as preeclamptic toxemia, diabetes mellitus, hepato-renal impediment ...etc
  • The presence of reported side effects in the mother from 17α hydroxy progesterone caproate like hypersensitivity reactions, cough, dyspnea, and diabetes.

研究组 & 干预措施

17α hydroxy progesterone caproate group

Active Comparator

干预措施: 17α hydroxy progesterone caproate (Drug)

结局指标

主要结局

number of women delivered before 37 weeks

时间窗: 13 weeks

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

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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