Conditions: Contraception
Keywords: IUD insertion Nulliparous women Contraception Family Planning IUD insertion in nulliparous women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: yes

Brief summary:
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.

Detailed 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.

Arms:
arm 1: Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. arm 2: Pills which are identical to the study drug in appearance, taste, and smell.

Interventions: intervention 1: Misoprostol intervention 2: Placebo
Intervention descriptions: intervention 1: 400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion. intervention 2: Pills which are identical to the study drug in appearance, taste, and smell.

Protocol document: