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Completed

NCT Number: NCT01248091

The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

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.

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Key information

Conditions

Cervical Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitroprusside Gel

Procedure

10 cc nitroprusside gel

Placebo Gel

Procedure

half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2010
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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