N/A
N=108
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00886834 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) — 25.1; 27.4 units on a scale — p=0.64
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Misoprostol (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Utah
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) |
25.1; 27.4 | 0.64 |
| SECONDARY Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) |
17.1; 4.8; 58.4; 56.9; 35.1; 27.5 | — |
Summary
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
Eligibility Criteria
Inclusion Criteria
- 18 years old or older
- negative pregnancy test
- no prior pregnancies beyond 14 6/7 weeks
- no PID in last 3 months
- no current cervicitis
- be willing to follow-up in 1-2 months for an IUD string check.
Exclusion Criteria
- active cervical infection
- current pregnancy
- prior pregnancy beyond 14 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.
Data sourced from ClinicalTrials.gov (NCT00886834). 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.