Human Papillomavirus and Pregnancy (HPVandPregn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01897129
Recruitment Status : Unknown
Verified July 2013 by Ulla Bonde van Zwol, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : July 11, 2013
Last Update Posted : July 11, 2013
MCM Vaccines B.V.
Region of Southern Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Bonde van Zwol, Odense University Hospital

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.

Condition or disease
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
Estimated Enrollment : 546 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Human Papillomavirus and Pregnancy
Study Start Date : November 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

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-)

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

Secondary Outcome Measures :
  1. Presence of Human Papillomavirus in uteri in the second trimester of pregnancy [ Time Frame: 1st of November 2015 ]
    Can HPV be found in the placenta during early pregnancy if the woman has HPV-infection on the ectocervix

  2. Human Papillomavirus infection in the cervix uteri in pregnant women at term [ Time Frame: 1st of November 2015 ]
    The prevalence of HPV in Danish pregnant women at term

Other Outcome Measures:
  1. HPV infection and preterm birth [ Time Frame: 1st of November 2015 ]
    Does HPV-infection in the cervix uteri increase the risk of preterm birth?

  2. HPV infection and miscarriage [ Time Frame: 1st of November 2015 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women in Funen, Denmark

Inclusion Criteria:

  • Pregnant women gestational week 10-42

Exclusion Criteria:

  • Vaccinated against cervical cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01897129

Contact: Ulla B van Zwol, Doctor +45 22622676

Department of Gynecology and Obstetrics Recruiting
Odense, Funen, Denmark, 5000
Contact: Ulla B van Zwol, Doctor    +45022622676   
Principal Investigator: Ulla B van Zwol, Doctor         
Sponsors and Collaborators
Ulla Bonde van Zwol
MCM Vaccines B.V.
Region of Southern Denmark
University of Southern Denmark
Study Chair: Jan S Joergensen, Doctor Supervisor

Responsible Party: Ulla Bonde van Zwol, MD, ph.d.-student, Odense University Hospital Identifier: NCT01897129     History of Changes
Other Study ID Numbers: HPV AND PREGNANCY
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections