The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

Pelvic Pain Clinical Trial

Official title:

The Effect of Nitroprusside on the IUD Insertion Experience in Nulliparous Women: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248091
• Other study ID #: Version 1.0
• Status: Completed
• Phase: N/A
• First received: November 23, 2010
• Last updated: September 12, 2012
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Pain
• Neck Pain
• Pelvic Pain

Intervention

Procedure:
• Nitroprusside Gel
10 cc nitroprusside gel
• Placebo Gel
half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No