The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
1 other identifier
interventional
24
1 country
1
Brief Summary
Increasing accessibility of long-acting reversible contraceptive methods, like intrauterine devices (IUDs), is an important strategy to reduce the risk of unintended pregnancy. Unfortunately, fear of IUD insertion in women who have not had children is common among health care providers and women alike, and this limits IUD use. To increase acceptance of this highly effective contraceptive, there is need to investigate novel, low cost, easily applied and accessible techniques to improve the insertion experience. This is a pilot study to evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 14, 2012
September 1, 2012
7 months
November 23, 2010
September 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.
over one year
Study Arms (2)
Placebo gel
PLACEBO COMPARATORNitroprusside Gel
EXPERIMENTALInterventions
half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.
Eligibility Criteria
You may qualify if:
- age 18-45,
- Generally Healthy.
- requesting LNG-IUS for contraception as the primary indication
You may not qualify if:
- previous pregnancy beyond 20 weeks,
- previous IUD placement or attempted placement,
- allergy to nitroprusside,
- history of migraines,
- history of heart disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Society of Family Planningcollaborator
Study Sites (1)
Oregon Health and Science University
Portland, Oregon, 97239, United States
Related Publications (1)
Bednarek PH, Micks EA, Edelman AB, Li H, Jensen JT. The effect of nitroprusside on IUD insertion experience in nulliparous women: a pilot study. Contraception. 2013 Apr;87(4):421-5. doi: 10.1016/j.contraception.2012.10.030. Epub 2012 Dec 4.
PMID: 23218853DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paula Bednarek, MD MPH
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 25, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 14, 2012
Record last verified: 2012-09