Human Papillomavirus and Pregnancy (HPVandPregn)

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.

Study Overview

• Status: Unknown
• Conditions: HPV-infection in Pregnant Women

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.

• Study Type: Observational
• Enrollment (Anticipated): 546

Contacts and Locations

• Study Contact: Name: Ulla B van Zwol, Doctor; Phone Number: +45 22622676; Email: ulla.zwol@rsyd.dk

Study Locations

• Denmark
  • Funen
    • Odense, Funen, Denmark, 5000
      • Recruiting
      • Department of Gynecology and Obstetrics
      • Contact: Ulla B van Zwol, Doctor; Phone Number: +45022622676; Email: ulla.zwol@rsyd.dk
      • Principal Investigator: Ulla B van Zwol, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in Funen, Denmark

Description

Inclusion Criteria:

• Pregnant women gestational week 10-42

Exclusion Criteria:

• Vaccinated against cervical cancer

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Early pregnancy; Women in early pregnancy at around the time of the nuchal translucency scan. The prevalence of HPV will be determined
Chorionic villous sampling; Women undergoing chorionic villous sampling for the purpose of prenatal diagnostics.
Spontaneous abortion; Women with miscarriage at a gestational age up to 22 weeks
Preterm birth; Women with spontaneous preterm birth/premature primary rupture of membranes at a gestational age week 22-32
Vaginal delivery at term; Women with spontaneous vaginal delivery at term (week 37+0-)
Elective ceaserean section at term; Women undergoing elective cesarean section at term (week 37+0-)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Papillomavirus infection of the uterine cervix in early pregnancy	Description of the prevalence of HPV in Danish pregnant women.	1st of November 2015

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Human Papillomavirus in uteri in the second trimester of pregnancy	Can HPV be found in the placenta during early pregnancy if the woman has HPV-infection on the ectocervix	1st of November 2015
Human Papillomavirus infection in the cervix uteri in pregnant women at term	The prevalence of HPV in Danish pregnant women at term	1st of November 2015

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV infection and preterm birth	Does HPV-infection in the cervix uteri increase the risk of preterm birth?	1st of November 2015
HPV infection and miscarriage	Does HPV infection increase the risk of miscarriage?	1st of November 2015

Collaborators and Investigators

• Sponsor: Ulla Bonde van Zwol
• Collaborators: University of Southern Denmark; Region of Southern Denmark; MCM Vaccines B.V.
• Investigators: Study Chair: Jan S Joergensen, Doctor, Supervisor

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 8, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 8, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: HPV AND PREGNANCY