A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
Overview
- Phase
- Not Applicable
- Intervention
- Misoprostol
- Conditions
- Contraception
- Sponsor
- University of Arizona
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Pam Lotke
Principal Investigator
University of Arizona
Eligibility Criteria
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
Arms & Interventions
misoprostol
400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion
Intervention: Misoprostol
Placebo
Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion
Intervention: Placebo
Outcomes
Primary Outcomes
The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale
Time Frame: after IUD insertion
Secondary Outcomes
- Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia(during IUD insertion)
- Side effects of medications(prior to IUD insertion)
- Provider perceived ease of insertion on a 100 mm visual analogue scale(after IUD insertion)
- Acceptability of wait time prior to IUD placement(1 week after 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)