A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women
Overview
- Phase
- Not Applicable
- Intervention
- Misoprostol
- Conditions
- Contraception
- Sponsor
- University of Utah
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
David Turok
Assistant Professor
University of Utah
Eligibility Criteria
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.
Arms & Interventions
Misoprostol
Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
Intervention: Misoprostol
Placebo
Pills which are identical to the study drug in appearance, taste, and smell.
Intervention: Placebo
Outcomes
Primary Outcomes
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)
Time Frame: Immediately post IUD insertion
VAS (anchors: 0 = extremely easy, 100 mm= impossible)
Secondary Outcomes
- Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)(prior to insertion, immediately after insertion, and prior to clinic discharge)