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OpenTrials
Completed

NCT Number: NCT01001897

Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women

The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPH-Kino multispecialty clinic, Tucson, Arizona, United States

Loading trial locations.

About this study

IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Nulliparous, no prior pregnancy beyond 14 week
  • Over 18 years of age
  • Negative pregnancy test

Exclusion criteria

  • current pregnancy or pregnancy within 6 weeks
  • current cervicitis or PID (active or within 3 months)
  • undiagnosed abnormal uterine bleeding
  • allergy to copper/ Wilson's disease (for Paragard)
  • cervical or uterine cancer
  • uterine anomaly altering uterine cavity

Treatment and study plan

Misoprostol

Drug

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Placebo

Drug

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Primary outcomes

  1. The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale

    Time frame: after IUD insertion

Secondary outcomes

  1. Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia

    Time frame: during IUD insertion

  2. Side effects of medications

    Time frame: prior to IUD insertion

  3. Provider perceived ease of insertion on a 100 mm visual analogue scale

    Time frame: after IUD insertion

  4. Acceptability of wait time prior to IUD placement

    Time frame: 1 week after IUD insertion

  5. Procedure complications

    Time frame: Up to 1 month after IUD placement

  6. Acceptability of total IUD placement process, would you recommend this to a friend?

    Time frame: 1 week and 1 month after IUD insertion

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2009
Registry last updated
Jun 14, 2012

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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