The association between preterm birth, vaginal microbiome, immune defence and HPV among women with cervical precancer

The association between preterm birth, vaginal microbiome, immune defence and HPV among women with cervical precancer: an observational single-center study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17063005

Enrollment

150

Registered

2016-03-22

Start date

2015-09-17

Completion date

Unknown

Last updated

2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV infection Infections and Infestations

Interventions

We will recruit women referred to colposcopy due to an abnormal Pap smear result, age 18 to 45, who are not pregnant and have no previous cervical operation. There are then allocated to one of three

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Healthy volunteers and colposcopy patients.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Vaginal bleeding 3. Previous cervical surgery

Design outcomes

Primary

Measure	Time frame
1. Presence of immunomarkers, using multiplex ELISA 2. HPV-status, using PCR 3. Analysis of microbiota, by measuring hypervariable 16S Results are compared between patients receiving treatment for HPV lesions with those that do not require treatment for lesions. Measurements are taken at baseline and 6 months later.	—

Secondary

Measure	Time frame
1. Presence of immunomarkers 2. HPV-status 3. Analysis of microbiota Results are compared between patients with HPV at a colposcopy clinic to "healthy" controls undergoing Pap screening. Measurements are taken at baseline and 6 months later.	—

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026