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Completed

NCT Number: NCT01307111

Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 14 years old or older
  • Negative pregnancy test
  • No prior pregnancies lasting beyond 19 6/7 weeks
  • Minimum 2 weeks after spontaneous or medical abortion
  • Minimum 4 weeks post 2nd trimester or surgical abortion
  • No previous IUD insertions
  • No PID in last 3 months
  • No current cervicitis
  • Willing to follow-up in 1-2 months for an IUD string check

Exclusion criteria

  • Active cervical infection
  • Current pregnancy
  • Prior pregnancy beyond 19 6/7 weeks gestation
  • Known uterine anomaly
  • Fibroid uterus distorting uterine cavity
  • Copper allergy/Wilson's Disease (for Paragard)
  • Undiagnosed abnormal uterine bleeding
  • Cervical or uterine cancer

Treatment and study plan

Misoprostol

Drug

400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.

Placebo

Drug

Pills which are identical to the study drug in appearance, taste, and smell.

Primary outcomes

  1. Patient Perceived Pain on a 100-point Visual Analogue Scale.

    Time frame: Prior to insertion, immediately after insertion, and prior to clinic discharge.

    Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.

Secondary outcomes

  1. Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.

    Time frame: Immediately post IUD insertion

    Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 2, 2011
Registry last updated
Mar 28, 2016

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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