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

November 23, 2010
September 12, 2012
December 2010
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01248091 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
The Effect of Nitroprusside on the IUD Insertion Experience in Nulliparous Women: a Pilot Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Cervical Pain
  • Pelvic Pain
  • Procedure: Nitroprusside Gel
    10 cc nitroprusside gel
    Other Name: 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.
    Other Name: Placebo gel
  • Placebo Comparator: Placebo gel
    Intervention: Procedure: Placebo Gel
  • Experimental: Nitroprusside Gel
    Intervention: Procedure: Nitroprusside Gel
Bednarek PH, Micks EA, Edelman AB, Li H, Jensen JT. The effect of nitroprusside on IUD insertion experience in nulliparous women: a pilot study. Contraception. 2013 Apr;87(4):421-5. doi: 10.1016/j.contraception.2012.10.030. Epub 2012 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01248091
Version 1.0
Yes
Paula Bednarek, Oregon Health and Science University
Oregon Health and Science University
Society of Family Planning
Principal Investigator: Paula Bednarek, MD MPH Oregon Health and Science University
Oregon Health and Science University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP