Human Papillomavirus and Pregnancy (HPVandPregn)

Ulla Bonde van Zwol

Status: Unknown

Conditions: HPV-infection in Pregnant Women

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01897129

HPV AND PREGNANCY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 546 estimated patients

Sex: Female

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women gestational week 10-42

Exclusion criteria

• Vaccinated against cervical cancer

Trial design

546 participants in 6 patient groups

Early pregnancy

Description:

Women in early pregnancy at around the time of the nuchal translucency scan. The prevalence of HPV will be determined

Chorionic villous sampling

Description:

Women undergoing chorionic villous sampling for the purpose of prenatal diagnostics.

Spontaneous abortion

Description:

Women with miscarriage at a gestational age up to 22 weeks

Preterm birth

Description:

Women with spontaneous preterm birth/premature primary rupture of membranes at a gestational age week 22-32

Vaginal delivery at term

Description:

Women with spontaneous vaginal delivery at term (week 37+0-)

Elective ceaserean section at term

Description:

Women undergoing elective cesarean section at term (week 37+0-)