HPV-infection in Pregnant WomenHPVandPregnNCT01897129
Human Papillomavirus and Pregnancy
An observational study of HPV-infection in Pregnant Women, run by Ulla Bonde van Zwol at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV-infection in Pregnant Women
- How many people
- 546 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women in Funen, Denmark
Who may be able to join
- Pregnant women gestational week 10-42
Who cannot join
- Vaccinated against cervical cancer
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics
Odense, Funen, 5000
Ulla B van Zwol, Doctor, +45022622676, ulla.zwol@rsyd.dk
Ulla B van Zwol, Doctor
About this study
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.
Read the 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.
- Conditions
- HPV-infection in Pregnant Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Human Papillomavirus infection of the uterine cervix in early pregnancy
Description of the prevalence of HPV in Danish pregnant women.
Measured: 1st of November 2015
Secondary outcomes (2)
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
Measured: 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
Measured: 1st of November 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionNov 2014 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-infection in Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulla Bonde van Zwol
- Sponsor type
- University, hospital or other
- Collaborators
- MCM Vaccines B.V., Region of Southern Denmark, University of Southern Denmark
- Responsible party
- Sponsor-investigator, Ulla Bonde van Zwol, Odense University Hospital
- Investigators
- Jan S Joergensen, Doctor, Study chair, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897129
- Sponsor's protocol ID
- HPV AND PREGNANCY
- Acronym
- HPVandPregn
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus and Pregnancy
- ClinicalTrials.gov ID
- NCT01897129
- Acronym / sponsor ID
- HPVandPregn / HPV AND PREGNANCY
- Conditions
- HPV-infection in Pregnant Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Ulla Bonde van ZwolUniversity, hospital or other
- Collaborators
- MCM Vaccines B.V., Region of Southern Denmark, University of Southern Denmark
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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-) |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women in Funen, Denmark
Key inclusion criteria (1 listed)
- Pregnant women gestational week 10-42
Key exclusion criteria (1 listed)
- Vaccinated against cervical cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Presence of Human Papillomavirus in uteri in the second trimester of pregnancy
Time frame: 1st of November 2015
Human Papillomavirus infection in the cervix uteri in pregnant women at term
Time frame: 1st of November 2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan S Joergensen, Doctor study chair
Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV-infection in Pregnant Women, run by Ulla Bonde van Zwol at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulla B van Zwol, Doctor (+45 22622676, ulla.zwol@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Papillomavirus infection of the uterine cervix in early pregnancy (time frame: 1st of November 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013; AzTrials last refreshed its copy on 30 Oct 2026.