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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
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Pain focused on measuring IUD, Insertion, Decrease, Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
November 23, 2010
Last Updated
September 12, 2012
Sponsor
Oregon Health and Science University
Collaborators
Society of Family Planning
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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

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The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

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