Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
- Registration Number
- NCT01147497
- Lead Sponsor
- Emory University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 78
- 18 years
- negative pregnancy test
- no prior pregnancy beyond 19 6/7 weeks
- no pelvic inflammatory disease in last 3 months
- no current cervicitis
- willing to follow up in 1-2 months
- active cervical infection
- current pregnancy
- prior pregnancy beyond 19 6/7 weeks
- uterine anomaly
- fibroid uterus distorting uterine cavity
- copper allergy or wilson's disease for ParaGard
- undiagnosed abnormal uterine bleeding
- cervical or uterine cancer
- sepsis associated with the most recent pregnancy
- current breast cancer for levonogestrel IUD
- inflammatory bowel disease
- allergy to misoprostol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit misoprostol Misoprostol Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
- Primary Outcome Measures
Name Time Method Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale assessed immediately post IUD insertion The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
- Secondary Outcome Measures
Name Time Method Patient Perceived Pain on a 100 Point Visual Analogue Scale immediately after insertion The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).
The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD assessed immediately after IUD insertion Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women assessed immediately following insertion Time for Insertion Procedure assessed immediately after IUD insertion Acceptability of Discomfort Associated With Insertion assessed at one week after insertion and at one month after insertion Need for Additional Pain Medications After Insertion of the IUD assessed one week after insertion
Trial Locations
- Locations (1)
The Emory Clinic
🇺🇸Atlanta, Georgia, United States