The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

NCT ID: NCT01248091

Last Updated: 2012-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-07-31

Brief 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.

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.

Conditions

Cervical Pain; Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo gel

Group Type: PLACEBO_COMPARATOR

Placebo Gel

Intervention Type: PROCEDURE

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

Nitroprusside Gel

Group Type: EXPERIMENTAL

Nitroprusside Gel

Intervention Type: PROCEDURE

10 cc nitroprusside gel

Interventions

Nitroprusside Gel

10 cc nitroprusside gel

Intervention Type: PROCEDURE

Placebo Gel

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Paula Bednarek

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula Bednarek, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23218853 (View on PubMed)

Other Identifiers

Version 1.0

Identifier Type: -

Identifier Source: org_study_id