An interventional study of Misoprostol and Placebo in Contraception, sponsored by Emory University. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-12.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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.
Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
Drug: Misoprostol
Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
Drug: Placebo
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
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
Enrollment occurred at a faculty practice clinic affiliated with Emory University.
| Milestone | Misoprostol | Placebo |
|---|---|---|
| Started | 37 | 36 |
| Completed | 35 | 36 |
| Not completed | 2 | 0 |
| Withdrew: Failed insertion | 2 | 0 |
The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
| units on a scale | Misoprostol | Placebo |
|---|---|---|
| Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale | 21 (0 to 100) | 21 (0 to 68) |
The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).
| units on a scale | Misoprostol | Placebo |
|---|---|---|
| Patient Perceived Pain on a 100 Point Visual Analogue Scale | 46 (11 to 92) | 34 (0 to 90) |
| participants | Misoprostol | Placebo |
|---|---|---|
| The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD | 7 | 3 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Misoprostol | — | 0/37 (0%) | 0/37 (0%) |
| Placebo | — | 0/36 (0%) | 0/36 (0%) |
| Age, Categorical(Participants) | Misoprostol | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 36 | 73 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Misoprostol | Placebo | Total |
|---|---|---|---|
| Mean | 26.05 ± .554 | 25.5 ± .554 | 25.775 ± .554 |
| Sex: Female, Male(Participants) | Misoprostol | Placebo | Total |
|---|---|---|---|
| Female | 37 | 36 | 73 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Misoprostol | Placebo | Total |
|---|---|---|---|
| United States | 37 | 36 | 73 |
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Emory University