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

Emory University

Status: Completed

Conditions: Contraception

Treatments: Drug: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01147497

IRB00021303

MISO Emory (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

misoprostol

Experimental group

Description:

Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit

Treatment:

Drug: Misoprostol

placebo

Placebo Comparator group

Description:

Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit

Treatment:

Drug: Placebo