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Completed

NCT Number: NCT01147497

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

Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Emory Clinic

Atlanta, Georgia, 30322, United States

About this study

There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years
  • negative pregnancy test
  • no prior pregnancy beyond 19 6/7 weeks
  • no pelvic inflammatory disease in last 3 months
  • no current cervicitis
  • willing to follow up in 1-2 months

Exclusion criteria

  • active cervical infection
  • current pregnancy
  • prior pregnancy beyond 19 6/7 weeks
  • uterine anomaly
  • fibroid uterus distorting uterine cavity
  • copper allergy or wilson's disease for ParaGard
  • undiagnosed abnormal uterine bleeding
  • cervical or uterine cancer
  • sepsis associated with the most recent pregnancy
  • current breast cancer for levonogestrel IUD
  • inflammatory bowel disease
  • allergy to misoprostol

Treatment and study plan

Misoprostol

Drug

400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit

Placebo

Drug

Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

Primary outcomes

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

    Time frame: assessed immediately post IUD insertion

    The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).

Secondary outcomes

  1. Patient Perceived Pain on a 100 Point Visual Analogue Scale

    Time frame: immediately after insertion

    The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).

  2. The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD

    Time frame: assessed immediately after IUD insertion

  3. Time for Insertion Procedure

    Time frame: assessed immediately after IUD insertion

  4. Acceptability of Discomfort Associated With Insertion

    Time frame: assessed at one week after insertion and at one month after insertion

  5. Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women

    Time frame: assessed immediately following insertion

  6. Need for Additional Pain Medications After Insertion of the IUD

    Time frame: assessed one week after insertion

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: miso

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Jan 12, 2018

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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