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

University of Arizona

Status: Completed

Conditions: Contraception

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01001897

09004201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

misoprostol

Experimental group

Description:

400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Description:

Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion

Treatment:

Drug: Placebo