A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of New Mexico
- Enrollment
- 85
- Primary Endpoint
- Patient Perceived Pain on a 100-point Visual Analogue Scale.
Study Overview
Brief Summary
The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.
Detailed Description
The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •14 years old or older
- •Negative pregnancy test
- •No prior pregnancies lasting beyond 19 6/7 weeks
- •Minimum 2 weeks after spontaneous or medical abortion
- •Minimum 4 weeks post 2nd trimester or surgical abortion
- •No previous IUD insertions
- •No PID in last 3 months
- •No current cervicitis
- •Willing to follow-up in 1-2 months for an IUD string check
Exclusion Criteria
- •Active cervical infection
- •Current pregnancy
- •Prior pregnancy beyond 19 6/7 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 buccally or vaginally, per the participants desire.
Intervention: Misoprostol (Drug)
Placebo
Pills which are identical to the study drug in appearance, taste, and smell.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Patient Perceived Pain on a 100-point Visual Analogue Scale.
Time Frame: Prior to insertion, immediately after insertion, and prior to clinic discharge.
Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.
Secondary Outcomes
- Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.(Immediately post IUD insertion)
Investigators
Eve Espey
Professor, OB-GYN
University of New Mexico