An interventional study of Misoprostol and Placebo in Contraception, sponsored by University of Arizona. Completed at 2 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-14.
Sponsored by University of Arizona · Not applicable, Interventional, and Health services research
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.
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.
University of Arizona is the lead sponsor of 465 studies on the registry; 86 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion
Drug: Misoprostol
Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion
Drug: Placebo
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
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
Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia
Time frame: during IUD insertion
Side effects of medications
Time frame: prior to IUD insertion
Provider perceived ease of insertion on a 100 mm visual analogue scale
Time frame: after IUD insertion
Acceptability of wait time prior to IUD placement
Time frame: 1 week after IUD insertion
Procedure complications
Time frame: Up to 1 month after IUD placement
Acceptability of total IUD placement process, would you recommend this to a friend?
Time frame: 1 week and 1 month after IUD insertion
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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University of Arizona