Short summary

An observational and case-control study to determine the prevalence of human papillomavirus (HPV) in pregnancy, the potential effect HPV has on pregnancy outcomes more particularly spontaneous abortion and spontaneous preterm birth. Analyzes of cervical swaps, blood samples and of placental tissue are performed to test and genotype for HPV. Materials from vaginal swaps are stored in the biobank for future analyzes of the vaginal microbiota.

Rationale

The present study is important to determine the influence of human papillomavirus (HPV) on the risk of miscarriage and spontaneous preterm birth in pregnancy.

Some studies have shown significantly higher prevalence of HPV in tissue from spontaneous abortions (60%) than in tissue from elective abortions (20-30%) (Hermonat et al, Srinivas et al). The same tendency is shown in terms of preterm birth.

Only 4 types of HPV are currently vaccinated against and these 4 types are selected on the basis of their potential of being oncogenic or causing genital warts. In the present study, analyzes are performed to detect the 35 types of HPV, which are known to, potentially, be present in the ano-genital area.

There is some knowledge about the four types of HPV vaccinated against but not much about the remaining 31 types. The potential negative impact these 35 types can have on the outcome of pregnancy is examined here.

The women will be examined by swab from the cervix uteri to detect any HPV-infection and genotype, if present as well as a blood sample is taken to analyze for antibodies against HPV. Furthermore an analysis for detection of HPV in placental tissue from placental sampling and from evacuation of retained products of conception at spontaneous abortion/miscarriage will be made in the relevant groups. Cervical swabs of placental tissue will be analyzed for the 35 types of HPV, which are the most frequently present in the anogenital area.

This study has the potential to elucidate the role of HPV on adverse outcomes of pregnancy and by means of knowledge on this subject to stimulate further research of and extended use of vaccination against HPV. The clinical result is expected to be a reduction of spontaneous abortions and preterm deliveries with the resulting less personal human, psychological, physical and socioeconomic costs.

Description of the cohort

The 546 women are included in 6 different groups of 91 women:

• At the nuchal translucency scan (12-14 weeks of gestation)
• At the chorionic villus sampling (12-15 weeks of gestation)
• Spontaneous abortion (up till 22 weeks of gestation)
• Pretem birth (22 to 34 weeks of gestation)
• Birth at term, vaginally or cesarean section (37 to 42 weeks of gestation)
• Non-pregnant women aged 23 to 45 years

Data and biological material

Biological material:

• Cervical swaps
• Vaginal swaps
• Blood samples
• Questionnaire

Collaborating researchers and departments

Department of Gynaecology and Obstetrics, Odense University Hospital and Institute of Clinical Research, University of Southern Denmark

• PhD Student and Medical Specialist Ulla Bonde van Zwol
• Associate Professer and Chief Obstetrician Jan Stener Jørgensen, MD, PhD
• Professor and Chief Consultant Ole Mogensen, DMSc

Department of Pathology, Hvidovre Hospital

• Molecular Biologist and Senior Researcher Jesper Hansen Bonde

Dept. of Pathology, Odense University Hospital

• Clinical Associate Professor Doris Schledermann, MD

OPEN Odense Patient data Explorative Network, Odense University Hospital