NCT01248091

The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Pain
• Pelvic Pain

Interventions

Type	Name	Description
PROCEDURE	Nitroprusside Gel	10 cc nitroprusside gel
PROCEDURE	Placebo Gel	half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-11-25
• Last updated: 2012-09-14

Locations

1 site across 1 country: United States