Contraception
Conditions
Keywords
IUD insertion, nulliparous women, contraception
Brief summary
The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.
Detailed description
IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.
Interventions
DRUGMisoprostol
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
DRUGPlacebo
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous, no prior pregnancy beyond 14 week * Over 18 years of age * Negative pregnancy test
Exclusion criteria
* current pregnancy or pregnancy within 6 weeks * current cervicitis or PID (active or within 3 months) * undiagnosed abnormal uterine bleeding * allergy to copper/ Wilson's disease (for Paragard) * cervical or uterine cancer * uterine anomaly altering uterine cavity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale | after IUD insertion |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of medications | prior to IUD insertion |
| Provider perceived ease of insertion on a 100 mm visual analogue scale | after IUD insertion |
| Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia | during IUD insertion |
| Procedure complications | Up to 1 month after IUD placement |
| Acceptability of total IUD placement process, would you recommend this to a friend? | 1 week and 1 month after IUD insertion |
| Acceptability of wait time prior to IUD placement | 1 week after IUD insertion |
Countries
United States
Outcome results
None listed