HPV-infection in Pregnant Women Clinical Trial
Official title:
Human Papillomavirus and Pregnancy
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.
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.
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Observational Model: Case Control, Time Perspective: Cross-Sectional