Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement

Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01496898

Enrollment

Registered

2011-12-21

Start date

2011-01-31

Completion date

2013-07-31

Last updated

2016-01-13

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

Conditions

Contraception, Cytokine, Human Microbiome, Metagenome

Keywords

Microflora, Vaginal, Cervical, Uterine, Inflammation, Cytokine, Intrauterine Device, Levonorgestrel

Brief summary

The goal of this study is to examine changes in the bacterial ecology and inflammatory markers of the female genital tract with levonorgestrel intrauterine device placement. The specific research objectives of this project include: 1. Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples will be collected up to 1 week before and 2 months after IUD insertion. 2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis. Samples will be analyzed from up to one day before and three weeks after IUD insertion. 3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Not currently pregnant * No use of hormonal birth control for at least three months prior to enrollment * Desiring levonorgestrel IUD for birth control * Greater than 6 months postpartum * Greater than 6 weeks after miscarriage * No antibiotic use in the past 6 weeks

Exclusion criteria

* Uterine Abnormalities * Current use of hormonal contraceptives or use less than 3 months ago * Unexplained vaginal bleeding * Irregular menses * Cervical dysplasia * Cervical or vaginal infection in the last 6 weeks * Douching within the week prior to sample collection * Use of vaginal lubricants within the week prior to sample collection

Design outcomes

Primary

Measure	Time frame	Description
Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement	1 week prior to IUD insertion to 2 months after IUD insertion	Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis

Secondary

Measure	Time frame	Description
Inflammatory cytokine changes with levonorgestrel intrauterine device placement	1 day prior to IUD insertion to 3 weeks after IUD insertion	Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis.

Countries

United States

Outcome results