Misoprostol With Intrauterine Device Insertion

NCT00613366 | Completed Results

• 1 other identifier: OHSU RES 3489
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Contraception

Keywords

intrauterine device; cervical dilation; nulliparous women; pain management

Outcome Measures

Primary Outcomes (1)

• The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).

  Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).

  Time of IUD insertion

Secondary Outcomes (1)

• Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).

  At time of IUD insertion

Study Arms (2)

Misoprostol

EXPERIMENTAL

Cervical preparation with misoprostol prior to intrauterine device insertion

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

Cervical preparation with placebo prior to intrauterine device insertion

Dietary Supplement: Magnesium Oxide

Interventions

Misoprostol DRUG

Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Also known as: prostaglandin

Misoprostol

Magnesium Oxide DIETARY_SUPPLEMENT

Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Also known as: Magnesium, Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette

You may not qualify if:

• Pregnancy occurring less than 6 weeks from time of presentation
• History of prior intrauterine device 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 insertion
• Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Planned Parenthood of the Columbia Willamette

Portland, Oregon, 97206, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.

  PMID: 21527040 DERIVED

Related Links

• (Women's Health Research Unit website)

MeSH Terms

Conditions

Agnosia

Interventions

Misoprostol; Prostaglandins; Magnesium Oxide; Magnesium

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals

Results Point of Contact

• Title: Dr. Alison Edelman
• Organization: Oregon Health & Science University

edelmana@ohsu.edu

503.494.5949

Study Officials

• Alison Edelman, M.D., M.P.H

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MPH

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 13, 2008
• Study Start: June 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 15, 2013
• Results First Posted: March 15, 2013

Record last verified: 2013-02

Locations

US (2)