Human Papillomavirus and Pregnancy

HPV-infection in Pregnant Women Clinical Trial

— HPVandPregn  

Official title:

Human Papillomavirus and Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01897129
• Other study ID #: HPV AND PREGNANCY
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2013
• Last updated: July 8, 2013
• Start date: November 2011
• Est. completion date: November 2015

Study information

• Verified date: July 2013
• Source: Odense University Hospital
• Contact: Ulla B van Zwol, Doctor
• Phone: +45 22622676
• Email: ulla.zwol[@]rsyd.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish Data Protection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 546
• Est. completion date: November 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Pregnant women gestational week 10-42

Exclusion Criteria:

• Vaccinated against cervical cancer

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HPV-infection in Pregnant Women

Locations

Country	Name	City	State
Denmark	Department of Gynecology and Obstetrics	Odense	Funen

Sponsors (4)

Lead Sponsor	Collaborator
Ulla Bonde van Zwol	Region of Southern Denmark, Sanofi Pasteur MSD, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HPV infection and preterm birth	Does HPV-infection in the cervix uteri increase the risk of preterm birth?	1st of November 2015	No
Other	HPV infection and miscarriage	Does HPV infection increase the risk of miscarriage?	1st of November 2015	No
Primary	Human Papillomavirus infection of the uterine cervix in early pregnancy	Description of the prevalence of HPV in Danish pregnant women.	1st of November 2015	No
Secondary	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	No
Secondary	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	No