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

University of New Mexico (UNM)

Status: Completed

Conditions: Pain

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01307111

HRRC #09-426

Details and patient eligibility

About

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Full description

The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Enrollment: 85 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 14 years old or older
• Negative pregnancy test
• No prior pregnancies lasting beyond 19 6/7 weeks
• Minimum 2 weeks after spontaneous or medical abortion
• Minimum 4 weeks post 2nd trimester or surgical abortion
• No previous IUD insertions
• No PID in last 3 months
• No current cervicitis
• Willing to follow-up in 1-2 months for an IUD string check

Exclusion criteria

• Active cervical infection
• Current pregnancy
• Prior pregnancy beyond 19 6/7 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Description:

Pills which are identical to the study drug in appearance, taste, and smell.

Treatment:

Drug: Placebo