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

• Patient perceived pain on a 100-point visual analogue scale [ Time Frame: prior to insertion, immediately after insertion, and prior to clinic discharge ] [ Designated as safety issue: No ]
• Ability to insert the IUD without the use of adjunctive measures including ultrasound guidance or cervical dilation [ Time Frame: During IUD insertion and immediately after ] [ Designated as safety issue: No ]
• Time for IUD insertion procedure [ Time Frame: assessed immediately after IUD insertion ] [ Designated as safety issue: No ]
• Presence of medication side effects [ Time Frame: assessed prior to IUD insertion, prior to leaving clinic and at 1 week follow-up ] [ Designated as safety issue: No ]
• Procedure complications [ Time Frame: Assessed up to 1 month from time of IUD insertion ] [ Designated as safety issue: Yes ]
• Need for additional pain medications the week following the procedure [ Time Frame: 1 week after IUD insertion ] [ Designated as safety issue: No ]

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.

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.

• Drug: Misoprostol
  400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.
  Other Name: Cytotec
• Drug: Placebo
  Pills which are identical to the study drug in appearance, taste, and smell.

• Experimental: Misoprostol
  Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
  Intervention: Drug: Misoprostol
• Placebo Comparator: Placebo
  Pills which are identical to the study drug in appearance, taste, and smell.
  Intervention: Drug: Placebo

• Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7.
• 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.

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.