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The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Pain; Pelvic Pain

Intervention: Nitroprusside Gel (Procedure); Placebo Gel (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Paula Bednarek, MD MPH, Principal Investigator, Affiliation: Oregon Health and Science University

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.

Clinical Details

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

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

Primary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Locations and Contacts

Oregon Health and Science University, Portland, Oregon 97239, United States
Additional Information

Starting date: December 2010
Last updated: September 12, 2012

Page last updated: August 23, 2015

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