Skip to main content
OpenTrials
Completed

NCT Number: NCT00886834

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

The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood Association of Utah, Salt Lake City, Utah, United States

Loading trial locations.

About this study

Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. 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 use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years old or older
  • negative pregnancy test
  • no prior pregnancies beyond 14 6/7 weeks
  • no PID in last 3 months
  • no current cervicitis
  • be willing to follow-up in 1-2 months for an IUD string check.

Exclusion criteria

  • active cervical infection
  • current pregnancy
  • prior pregnancy beyond 14 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 vaginally or buccally, per the participants desire prior to the IUD insertion.

Other names: Cytotec

Placebo

Drug

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

Primary outcomes

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

    Time frame: Immediately post IUD insertion

    VAS (anchors: 0 = extremely easy, 100 mm= impossible)

Secondary outcomes

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

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

    VAS; anchors: 0 =none, 100 mm= worst imaginable

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women

Acronym: MPIIN

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 23, 2009
Registry last updated
Dec 22, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.