Human Papillomavirus and Pregnancy (HPVandPregn)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Odense University Hospital
Sponsor:
Collaborators:
Sanofi Pasteur MSD
Region Southern Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Bonde van Zwol, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01897129
First received: July 8, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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.


Condition
HPV-infection in Pregnant Women

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Human Papillomavirus and Pregnancy

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Human Papillomavirus infection of the uterine cervix in early pregnancy [ Time Frame: 1st of November 2015 ] [ Designated as safety issue: No ]
    Description of the prevalence of HPV in Danish pregnant women.


Secondary Outcome Measures:
  • Presence of Human Papillomavirus in uteri in the second trimester of pregnancy [ Time Frame: 1st of November 2015 ] [ Designated as safety issue: No ]
    Can HPV be found in the placenta during early pregnancy if the woman has HPV-infection on the ectocervix

  • Human Papillomavirus infection in the cervix uteri in pregnant women at term [ Time Frame: 1st of November 2015 ] [ Designated as safety issue: No ]
    The prevalence of HPV in Danish pregnant women at term


Other Outcome Measures:
  • HPV infection and preterm birth [ Time Frame: 1st of November 2015 ] [ Designated as safety issue: No ]
    Does HPV-infection in the cervix uteri increase the risk of preterm birth?

  • HPV infection and miscarriage [ Time Frame: 1st of November 2015 ] [ Designated as safety issue: No ]
    Does HPV infection increase the risk of miscarriage?


Biospecimen Retention:   Samples With DNA

Biospecimen will be kept in a biobank for a period of 10 years after the end of this project. The biospecimens will be blood samples, cells collected from the ectocervix, vaginal microbioma, placental biopsies from prenatal diagnostics or miscarriages.


Estimated Enrollment: 546
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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-)

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

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women in Funen, Denmark

Criteria

Inclusion Criteria:

  • Pregnant women gestational week 10-42

Exclusion Criteria:

  • Vaccinated against cervical cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897129

Contacts
Contact: Ulla B van Zwol, Doctor +45 22622676 ulla.zwol@rsyd.dk

Locations
Denmark
Department of Gynecology and Obstetrics Recruiting
Odense, Funen, Denmark, 5000
Contact: Ulla B van Zwol, Doctor    +45022622676    ulla.zwol@rsyd.dk   
Principal Investigator: Ulla B van Zwol, Doctor         
Sponsors and Collaborators
Ulla Bonde van Zwol
Sanofi Pasteur MSD
Region Southern Denmark
University of Southern Denmark
Investigators
Study Chair: Jan S Joergensen, Doctor Supervisor
  More Information

No publications provided

Responsible Party: Ulla Bonde van Zwol, MD, ph.d.-student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01897129     History of Changes
Other Study ID Numbers: HPV AND PREGNANCY
Study First Received: July 8, 2013
Last Updated: July 8, 2013
Health Authority: Denmark: The Danish Data Protection Agency

ClinicalTrials.gov processed this record on September 18, 2014