Clinical trial NCT01897129: Human Papillomavirus and Pregnancy
Official title: Human Papillomavirus and Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV-infection in Pregnant Women
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: MCM Vaccines B.V.
name: Region of Southern Denmark
name: University of Southern Denmark
First posted: 2013-07-11
Enrollment: 546
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in Funen, Denmark

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women gestational week 10-42

Exclusion Criteria:

* Vaccinated against cervical cancer

Primary outcomes:
measure: Human Papillomavirus infection of the uterine cervix in early pregnancy
timeFrame: 1st of November 2015
Secondary outcomes:
measure: Presence of Human Papillomavirus in uteri in the second trimester of pregnancy
timeFrame: 1st of November 2015
measure: Human Papillomavirus infection in the cervix uteri in pregnant women at term
timeFrame: 1st of November 2015
Other outcomes:
measure: HPV infection and preterm birth
timeFrame: 1st of November 2015
measure: HPV infection and miscarriage
timeFrame: 1st of November 2015
Locations:
city: Odense
country: Denmark
facility: Department of Gynecology and Obstetrics
state: Funen
Study officials:
affiliation: Supervisor
name: Jan S Joergensen, Doctor
role: STUDY_CHAIR
References: