The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Pain, Pelvic Pain

Intervention / Treatment
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* Procedure: Nitroprusside Gel
* Procedure: Placebo Gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo gel<br> | Procedure: Placebo Gel<br>* half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.<br>|
| Experimental: Nitroprusside Gel<br> | Procedure: Nitroprusside Gel<br>* 10 cc nitroprusside gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUD, Insertion, Decrease, Pain