The Emory Clinic
Atlanta, Georgia, 30322, United States
NCT Number: NCT01147497
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Atlanta, Georgia, 30322, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: assessed immediately post IUD insertion
The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
Time frame: immediately after insertion
The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).
Time frame: assessed immediately after IUD insertion
Time frame: assessed immediately after IUD insertion
Time frame: assessed at one week after insertion and at one month after insertion
Time frame: assessed immediately following insertion
Time frame: assessed one week after insertion
Emory University
Other
A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women
Acronym: miso
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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