- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01248091
The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
September 12, 2012 updated by: Paula Bednarek, Oregon Health and Science University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo gel
|
half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.
|
Experimental: Nitroprusside Gel
|
10 cc nitroprusside gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time 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.
Time Frame: over one year
|
over one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paula Bednarek, MD MPH, Oregon Health and Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 23, 2010
First Submitted That Met QC Criteria
November 24, 2010
First Posted (Estimate)
November 25, 2010
Study Record Updates
Last Update Posted (Estimate)
September 14, 2012
Last Update Submitted That Met QC Criteria
September 12, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version 1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Pain
-
University of DeustoUniversity of the Basque Country (UPV/EHU); Osakidetza; Matia FoundationRecruitingCervical Pain | Cervical Radiculopathy | Cervical Radicular PainSpain
-
Afyonkarahisar Health Sciences UniversityCompletedMusculoskeletal Diseases | Cervical Pain | Radiculopathy | Cervical Disc Disease | Cervical Radicular PainTurkey
-
Palo Alto Veterans Institute for ResearchAllerganCompletedSubacute Cervical Pain | Subacute Upper Back Pain
-
Ahram Canadian UniversityRecruiting
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
University of UtahRecruitingCervical Pain | Cervical Facet Joint PainUnited States
-
Fayoum University HospitalCompletedInjection | Intervention | Epidural | CervicalEgypt
-
Jaseng Hospital of Korean MedicineCompletedLumbar and Cervical PainKorea, Republic of
-
Region SkaneUnknownNeck Pain | Cervical Disc Disease | Radiculopathy, Cervical | Cervical Foraminal Stenosis
-
Istanbul Medipol University HospitalCompletedPain | Cervical Radiculopathy | Cervical Disc Disease | Cervical Disc Herniation | Cervical Radicular Pain | Cervical; HerniaTurkey
Clinical Trials on Placebo Gel
-
Starpharma Pty LtdNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompletedHealthyUnited States, Puerto Rico
-
NutravaliaSlb PharmaCompletedOverweight and ObesityFrance
-
E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Recruiting
-
Topokine Therapeutics, Inc.SuspendedExcess Submental Fat ("Double Chin")
-
Population CouncilCompletedHIV InfectionUnited States
-
Xinnate ABRegion SkaneCompletedBlister | Epidermolysis Bullosa | Wound of Skin | Varicose Ulcer of Lower LimbSweden
-
Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
-
Starpharma Pty LtdCompletedBacterial VaginosisUnited States
-
Suzhou Kintor Pharmaceutical Inc,CompletedAcne Vulgaris | Androgenetic AlopeciaUnited States
-
Kalypsys, Inc.CompletedNeuropathic Pain | Herpes Zoster | Postherpetic Neuralgia | ShinglesUnited States