N/A N=82 Randomized Triple-blind Treatment

Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01307111 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Patient Perceived Pain on a 100-point Visual Analogue Scale. — 0.5; 0.8; 5.8; 5.9 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Misoprostol (Drug); Placebo (Drug)
Age: Pediatric, Adult · 14+ yrs
Sex: Female
Sponsor: University of New Mexico
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Perceived Pain on a 100-point Visual Analogue Scale.	0.5; 0.8; 5.8; 5.9; 3.2; 3.8	—
SECONDARY Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.	2.2; 2.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01307111). 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.