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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Contraception

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00886834

24403

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 108 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

Misoprostol 400 micrograms inserted vaginally or buccally, 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