Clinical trial NCT01496898: Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
Official title: Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Microbiome
Metagenome
Contraception
Cytokine
Keywords: Microflora
Vaginal
Cervical
Uterine
Inflammation
Cytokine
Intrauterine Device
Levonorgestrel
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2011-12-21
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion criteria.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement
timeFrame: 1 week prior to IUD insertion to 2 months after IUD insertion
Secondary outcomes:
measure: Inflammatory cytokine changes with levonorgestrel intrauterine device placement
timeFrame: 1 day prior to IUD insertion to 3 weeks after IUD insertion
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Janet C Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacobson JC, Turok DK, Dermish AI, Nygaard IE, Settles ML. Vaginal microbiome changes with levonorgestrel intrauterine system placement. Contraception. 2014 Aug;90(2):130-5. doi: 10.1016/j.contraception.2014.04.006. Epub 2014 Apr 21.