The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
Primary Purpose
Cervical Pain, Pelvic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nitroprusside Gel
Placebo Gel
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Pain focused on measuring IUD, Insertion, Decrease, Pain
Eligibility Criteria
Inclusion Criteria:
- age 18-45,
- Generally Healthy.
- requesting LNG-IUS for contraception as the primary indication
Exclusion Criteria:
- previous pregnancy beyond 20 weeks,
- previous IUD placement or attempted placement,
- allergy to nitroprusside,
- history of migraines,
- history of heart disease.
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo gel
Nitroprusside Gel
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.
Secondary Outcome Measures
Full Information
NCT ID
NCT01248091
First Posted
November 23, 2010
Last Updated
September 12, 2012
Sponsor
Oregon Health and Science University
Collaborators
Society of Family Planning
1. Study Identification
Unique Protocol Identification Number
NCT01248091
Brief Title
The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
Official Title
The Effect of Nitroprusside on the IUD Insertion Experience in Nulliparous Women: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Society of Family Planning
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Subjects who are have already scheduled an IUD insertion will be asked to join this study assessing whether or not nitroprusside gel helps with IUD insertion process. Only healthy, nulliparous women between the ages of 18 and 45 will be recruited. Nulliparous women report much more pain associated with IUD insertion than parous women so the possibility of being able to measure the effect of nitroprusside vs placebo is more likely. The primary outcome, pain with IUD insertion, and the secondary outcomes, such as satisfaction and provider ease of IUD insertion, will be compared between the study groups as well.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain, Pelvic Pain
Keywords
IUD, Insertion, Decrease, Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo gel
Arm Type
Placebo Comparator
Arm Title
Nitroprusside Gel
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Nitroprusside Gel
Intervention Description
10 cc nitroprusside gel
Intervention Type
Procedure
Intervention Name(s)
Placebo Gel
Intervention Description
half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.
Primary Outcome Measure Information:
Title
Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.
Time Frame
over one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-45,
Generally Healthy.
requesting LNG-IUS for contraception as the primary indication
Exclusion Criteria:
previous pregnancy beyond 20 weeks,
previous IUD placement or attempted placement,
allergy to nitroprusside,
history of migraines,
history of heart disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Bednarek, MD MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23218853
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
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