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

March 9, 2016 updated by: Eve Espey, University of New Mexico

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

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

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately post IUD insertion

Collaborators and Investigators

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

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Eve Espey, MD/MPH, University of New Mexico 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

February 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRRC #09-426

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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