Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization\[1\], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit
The Emory Clinic
Atlanta, Georgia, United States
Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale
The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
Time frame: assessed immediately post IUD insertion
Patient Perceived Pain on a 100 Point Visual Analogue Scale
The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).
Time frame: immediately after insertion
The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD
Time frame: assessed immediately after IUD insertion
Time for Insertion Procedure
Time frame: assessed immediately after IUD insertion
Acceptability of Discomfort Associated With Insertion
Time frame: assessed at one week after insertion and at one month after insertion
Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women
Time frame: assessed immediately following insertion
Need for Additional Pain Medications After Insertion of the IUD
Time frame: assessed one week after insertion
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