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The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Paula Bednarek, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01248091
First received: November 23, 2010
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Cervical Pain
Pelvic Pain
 Procedure: Nitroprusside Gel
Procedure: Placebo Gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Nitroprusside on the IUD Insertion Experience in Nulliparous Women: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider. [ Time Frame: over one year ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo gel Procedure: Placebo Gel
half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.
Other Name: Placebo gel
Experimental: Nitroprusside Gel Procedure: Nitroprusside Gel
10 cc nitroprusside gel
Other Name: Nitroprusside Gel

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248091

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
Principal Investigator: Paula Bednarek, MD MPH Oregon Health and Science University
  More Information

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paula Bednarek, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01248091     History of Changes
Other Study ID Numbers: Version 1.0
Study First Received: November 23, 2010
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
IUD, Insertion, Decrease, Pain

Additional relevant MeSH terms:
Neck Pain
Pelvic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nitroprusside
 Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 19, 2013