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临床试验/NCT04152278
NCT04152278已完成不适用

Chlamydia Tracomatis and Other Lower Genital Tract Infections Among Women With Unexplained Early Miscarriage

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年9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
600
试验地点
1
主要终点
the association of lower genital tract infection with spontaneous miscarriage

研究概览

简要总结

Although one fourth of pregnant women experience at least 1 abortion, yet only 50% of causes are identified. Pregnancy loss can result from viral, bacterial, and other infections. It can reach the fetoplacental units through blood born or local spread. Lower genital tract infections- a potentially preventable infections- was suggested as a cause of spontaneous miscarriage. It was reported in 15 and 66% of early and late miscarriages respectively. These infections are also commonly encountered among apparently healthy looking pregnant women with an overall prevalence of 40-54%. If left untreated it can lead to premature rupture of the membranes, preterm birth, low birth weight, Fetal loss, neonatal ophthalmic and pulmonary damage.

详细描述

Abortion was defined by the World Health Organization and the National Center for Health Statistics as pregnancy termination before 20 weeks of gestational age or fetal weight smaller than 500 grams. Abortion is termed early or late if it occurs before 12 weeks or between 12 and 24 weeks of gestation respectively.

Spontaneous abortion prevalence is not exactly known as it varies according to the used method of identification. Wilcox and colleagues in 1988 reported a prevalence of 31 % of pregnancy loss after implantation and over 2/3 of them were clinically silent.

Although one fourth of pregnant women experience at least 1 abortion, yet only 50% of causes are identified. Pregnancy loss can result from viral, bacterial, and other infections. It can reach the fetoplacental units through blood born or local spread.

Lower genital tract infections- a potentially preventable infections- was suggested as a cause of spontaneous miscarriage. It was reported in 15 and 66% of early and late miscarriages respectively. These infections are also commonly encountered among apparently healthy looking pregnant women with an overall prevalence of 40-54%. If left untreated it can lead to premature rupture of the membranes, preterm birth, low birth weight, Fetal loss, neonatal ophthalmic and pulmonary damage.

The suggested mechanisms that genital tract infection can cause abortions are encountered are fetal or placental infection with production of toxic metabolites.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with unexplained spontaneous miscarriage or missed abortion during the first and early second trimester of pregnancy (8-16 weeks gestational age).
  • women with normal pregnancy, attending the antenatal clinic of gestational age 8-16 weeks.
  • The included women aged 18 to 45 years old.

排除标准

  • women with miscarriage at a gestational age of more than 18 weeks,
  • those with documented causes of miscarriage as fetal or uterine anomalies, antiphospholipid syndrome or endocrine factors and
  • women who received recent antibiotic, antifungal or antiprotozoal treatment.

结局指标

主要结局

the association of lower genital tract infection with spontaneous miscarriage

时间窗: one year

relation between genital tract infection and miscarriage

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

Sahar MY Elbaradie

associate Professor

Fayoum University Hospital

研究点 (1)

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