Misoprostol With Intrauterine Device (IUD) Insertion - Full Text View

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00613366

Purpose

The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an IUD (intrauterine device) for contraception reduces pain in women who have never delivered a baby.

Condition	Intervention
Contraception	Drug: Misoprostol Dietary Supplement: Magnesium Oxide

MedlinePlus related topics: Birth Control

Drug Information available for: Misoprostol Magnesium oxide Magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Effect of Prophylactic Misoprostol Prior to IUD Insertion

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

The affect of misoprostol on the ease of IUD placement in nulliparous women. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The affect of misoprostol on the risk of IUD expulsion in nulliparous women. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2007
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Misoprostol Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
2: Placebo Comparator	Dietary Supplement: Magnesium Oxide Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Detailed Description:

We intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.

Subjects will be approached only after deciding to get an IUD. When the participants return for IUD placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion.

Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of IUD placement.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)
Ages 18-45
Seeking long-term reversible contraception with an IUD (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette

Exclusion Criteria:

Pregnancy occurring less than 6 weeks from time of presentation
History of prior IUD placement
History of Mullerian tract anomalies
History of uterine surgery
Allergy or intolerance to misoprostol or other prostaglandin
Pelvic inflammatory disease (current or within the past 3 months)
Sexually transmitted diseases (current)
Puerperal or postabortion sepsis (current or within the past 3 months)
Purulent cervicitis (current)
Undiagnosed abnormal vaginal bleeding
Malignancy of the genital tract
Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device (IUD) insertion
Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613366

Contacts

Contact: Women's Health Research Unit Confidential Recruitment Line	(503) 494-3666	whru@ohsu.edu
Contact: Laura Van Houten, M.D.	(503) 494-8311	vanhoute@ohsu.edu

Locations

United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Sub-Investigator: Paula Bednarek, M.D., M.P.H.
Sub-Investigator: Michelle Isley, M.D.
Sub-Investigator: Jeffrey Jensen, M.D., M.P.H.
Sub-Investigator: Mark Nichols, M.D.
Sub-Investigator: Laura Van Houten, M.D., MPH
Sub-Investigator: Marci Messerle Forbes, FNP
Sub-Investigator: Andrea O'Donnell, FNP
Principal Investigator: Alison Edelman, M.D., M.P.H.
Planned Parenthood of the Columbia Willamette	Recruiting
Portland, Oregon, United States, 97206
Principal Investigator: Alison Edelman, M.D., M.P.H.

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

Alison Edelman, M.D., M.P.H

Oregon Health and Science University

More Information

Additional Information:

(Women's Health Research Unit website) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	OHSU ( Alison Edelman, MD, MPH )
Study ID Numbers:	OHSU RES 3489
Study First Received:	January 29, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00613366 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

intrauterine device
cervical dilation
nulliparous women
pain management

Study placed in the following topic categories:

Magnesium Oxide
Dilatation, Pathologic
Misoprostol
Antacids
Pain

Additional relevant MeSH terms:

Magnesium Oxide
Molecular Mechanisms of Pharmacological Action
Oxytocics
Misoprostol
Physiological Effects of Drugs
Gastrointestinal Agents
Reproductive Control Agents

Abortifacient Agents, Nonsteroidal
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Anti-Ulcer Agents
Antacids

ClinicalTrials.gov processed this record on May 07, 2009