N/A
N=73
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01147497 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale — 21; 21 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Misoprostol (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale |
21; 21 | — |
| SECONDARY Patient Perceived Pain on a 100 Point Visual Analogue Scale |
46; 34 | — |
| SECONDARY The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD |
7; 3 | — |
| SECONDARY Time for Insertion Procedure |
— | — |
| SECONDARY Acceptability of Discomfort Associated With Insertion |
— | — |
| SECONDARY Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women |
— | — |
| SECONDARY Need for Additional Pain Medications After Insertion of the IUD |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01147497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.