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Completed

NCT Number: NCT00613366

Misoprostol With Intrauterine Device Insertion

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University, Portland, Oregon, United States

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About this study

The investigators 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 intrauterine. When the participants return for intrauterine device 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 intrauterine device placement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 intrauterine device (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 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)

Treatment and study plan

Misoprostol

Drug

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

Other names: prostaglandin

Magnesium oxide

Dietary Supplement

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

Other names: Magnesium, Placebo

Primary outcomes

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

    Time frame: Time of IUD insertion

    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).

Secondary outcomes

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

    Time frame: At time of IUD insertion

    Perceived pain 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).

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 13, 2008
Registry last updated
Mar 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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