The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

Not Applicable

Completed

• Conditions: Cervical Pain; Pelvic Pain
• Interventions: Procedure: Placebo Gel; Procedure: Nitroprusside Gel

• Registration Number: NCT01248091
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Start: 2010-12
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo gel	Placebo Gel	-
Nitroprusside Gel	Nitroprusside Gel	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States