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

A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women

Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

Study Overview

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

Detailed Description

There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic

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:

• 18 years
• negative pregnancy test
• no prior pregnancy beyond 19 6/7 weeks
• no pelvic inflammatory disease in last 3 months
• no current cervicitis
• willing to follow up in 1-2 months

Exclusion Criteria:

• active cervical infection
• current pregnancy
• prior pregnancy beyond 19 6/7 weeks
• uterine anomaly
• fibroid uterus distorting uterine cavity
• copper allergy or wilson's disease for ParaGard
• undiagnosed abnormal uterine bleeding
• cervical or uterine cancer
• sepsis associated with the most recent pregnancy
• current breast cancer for levonogestrel IUD
• inflammatory bowel disease
• allergy to misoprostol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: misoprostol; Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit	Drug: Misoprostol; 400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
Placebo Comparator: placebo; Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit	Drug: Placebo; Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

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	The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).	assessed immediately post IUD insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Perceived Pain on a 100 Point Visual Analogue Scale	The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).	immediately after insertion
The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD		assessed immediately after IUD insertion
Time for Insertion Procedure		assessed immediately after IUD insertion
Acceptability of Discomfort Associated With Insertion		assessed at one week after insertion and at one month after insertion
Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women		assessed immediately following insertion
Need for Additional Pain Medications After Insertion of the IUD		assessed one week after insertion

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Eva Lathrop, MD, MPH, Emory University School of Medicine, Department of Gynecology and Obstetrics

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.
• Lathrop E, Haddad L, McWhorter CP, Goedken P. Self-administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial. Contraception. 2013 Dec;88(6):725-9. doi: 10.1016/j.contraception.2013.07.011. Epub 2013 Aug 6.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 15, 2010
• First Submitted That Met QC Criteria: June 18, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: contraception; family planning; nulliparous women; IUD insertion; IUD insertion in nulliparous women
• 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: IRB00021303; MISO Emory (Other Identifier: Other)