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The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01248091
Enrollment
24
Registered
2010-11-25
Start date
2010-12-31
Completion date
2011-07-31
Last updated
2012-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Pain, Pelvic Pain

Keywords

IUD, Insertion, Decrease, Pain

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.

Interventions

PROCEDURENitroprusside Gel

10 cc nitroprusside gel

PROCEDUREPlacebo Gel

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

Sponsors

Society of Family Planning
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.over one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026