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

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Misoprostol; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85713
      • UPH-Kino multispecialty clinic
    • Tucson, Arizona, United States, 85724
      • University Medical Center Ob/Gyn clinic 8OPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: misoprostol; 400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion	Drug: Misoprostol; 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
Placebo Comparator: Placebo; Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion	Drug: Placebo; 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale	after IUD insertion

Secondary Outcome Measures

Outcome Measure	Time Frame
Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia	during IUD insertion
Side effects of medications	prior to IUD insertion
Provider perceived ease of insertion on a 100 mm visual analogue scale	after IUD insertion
Acceptability of wait time prior to IUD placement	1 week after IUD insertion
Procedure complications	Up to 1 month after IUD placement
Acceptability of total IUD placement process, would you recommend this to a friend?	1 week and 1 month after IUD insertion

Collaborators and Investigators

• Sponsor: University of Arizona

Publications and helpful links

General Publications

• Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.
• Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial. Am J Obstet Gynecol. 2014 Mar;210(3):208.e1-5. doi: 10.1016/j.ajog.2013.11.018. Epub 2013 Nov 8.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 13, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: contraception; nulliparous women; IUD insertion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 09004201