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临床试验/NCT01897129
NCT01897129Unknown不适用

Human Papillomavirus and Pregnancy

Ulla Bonde van Zwol1 个研究点 分布在 1 个国家目标入组 546 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
546
试验地点
1
主要终点
Human Papillomavirus infection of the uterine cervix in early pregnancy

研究概览

简要总结

Purpose Our study involves two hypotheses. One is that genital infection with HPV is associated with increased risk of miscarriage and preterm birth. The second hypothesis is that human papillomavirus can ascend from the vagina to the uterus through the cervix and cross the placental barrier. We wish to verify these hypotheses in our studies.

This study will determine the prevalence of HPV in Danish pregnant women and examine HPV's role in the aetiology of spontaneous abortion and preterm birth.

详细描述

Background Studies have shown significantly higher prevalence of HPV in tissue from miscarriages (60%) than from induced abortions (20%). HPV-infection in the extravillous trophoblasts in the placenta has furthermore been shown to induce cell death and cause dysfunction of the placenta, which can lead to adverse outcome of the pregnancy, e.g. preterm birth and hereby related neonatal mortality and morbidity. Spontaneous abortion and preterm birth are adverse events of the pregnancy, with for the biggest part unknown aetilogy, an area worth trying to elucidate by means of research.

Method 6 groups of each 91 women will be included:

  • A group of early pregnant women at the nuchal translucency scan around gestational week 12 and a similar group undergoing chorion villous sampling in relation to prenatal diagnostics of the fetus
  • A group of women with spontaneous abortion before gestational week 22 and a group with preterm birth gestational week 22-32
  • A group delivering spontaneously at term and a group undergoing elective cesarean at term

The women will be examined by cervical swab to analyze for and do a genotyping of HPV if present. A vaginal swab will be done for the purpose of vaginal microbiome examination later. Furthermore analysis for HPV in placental tissue from chorion villous sampling or evacuation of the uterus after miscarriage. Cervical swabs and placental tissue will be analyzed by means of PCR (polymerase chain reaction) for the 35 types of HPV most frequently found in the anogenital area. Blood samples will be collected from all the patients and analyzed for HPV-antibodies.

研究设计

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

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women gestational week 10-42

排除标准

  • Vaccinated against cervical cancer

结局指标

主要结局

Human Papillomavirus infection of the uterine cervix in early pregnancy

时间窗: 1st of November 2015

Description of the prevalence of HPV in Danish pregnant women.

次要结局

  • Presence of Human Papillomavirus in uteri in the second trimester of pregnancy(1st of November 2015)
  • Human Papillomavirus infection in the cervix uteri in pregnant women at term(1st of November 2015)

研究者

发起方
Ulla Bonde van Zwol
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ulla Bonde van Zwol

MD, ph.d.-student

Odense University Hospital

研究点 (1)

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