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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah
ClinicalTrials.gov Identifier:
NCT00886834
First received: April 22, 2009
Last updated: December 21, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Contraception
Drug: Misoprostol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) [ Time Frame: Immediately post IUD insertion ] [ Designated as safety issue: No ]
    VAS (anchors: 0 = extremely easy, 100 mm= impossible)


Secondary Outcome Measures:
  • Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) [ Time Frame: prior to insertion, immediately after insertion, and prior to clinic discharge ] [ Designated as safety issue: No ]
    VAS; anchors: 0 =none, 100 mm= worst imaginable


Enrollment: 108
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886834

Locations
United States, Utah
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84111
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: David Turok, MD/MPH University of Utah Department of Obstetrics and Gynecology
  More Information

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Turok, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00886834     History of Changes
Other Study ID Numbers: 24403
Study First Received: April 22, 2009
Results First Received: August 5, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
IUD insertion
Nulliparous women
Contraception
Family Planning
IUD insertion in nulliparous women

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014