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

December 4, 2014 updated by: David Turok, University of Utah

A Randomized Control Trial of Misoprostol vs. Placebo Prior to 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
      • Salt Lake City, Utah, United States, 84111
        • Planned Parenthood Association of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
Drug: Misoprostol
400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.
Other Names:
  • Cytotec
Placebo Comparator: Placebo
Pills which are identical to the study drug in appearance, taste, and smell.
Drug: Placebo
Pills which are identical to the study drug in appearance, taste, and smell.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediately post IUD insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
prior to insertion, immediately after insertion, and prior to clinic discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: David Turok, MD/MPH, University of Utah Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 22, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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