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The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion

NCT ID: NCT01248091

Last Updated: 2012-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Cervical Pain Pelvic Pain

Keywords

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IUD, Insertion, Decrease, Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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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

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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

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Society of Family Planning

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Paula Bednarek

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula Bednarek, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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

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Version 1.0

Identifier Type: -

Identifier Source: org_study_id