Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pam Lotke, University of Arizona

ClinicalTrials.gov Identifier:

NCT01001897

First received: October 26, 2009

Last updated: June 13, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 26, 2009
Last Updated Date	June 13, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2009)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01001897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2009)	Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia [ Time Frame: during IUD insertion ] [ Designated as safety issue: No ] Side effects of medications [ Time Frame: prior to IUD insertion ] [ Designated as safety issue: No ] Provider perceived ease of insertion on a 100 mm visual analogue scale [ Time Frame: after IUD insertion ] [ Designated as safety issue: No ] Acceptability of wait time prior to IUD placement [ Time Frame: 1 week after IUD insertion ] [ Designated as safety issue: No ] Procedure complications [ Time Frame: Up to 1 month after IUD placement ] [ Designated as safety issue: Yes ] Acceptability of total IUD placement process, would you recommend this to a friend? [ Time Frame: 1 week and 1 month after IUD insertion ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women
Official Title ^ICMJE	A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Health Services Research
Condition ^ICMJE	Contraception
Intervention ^ICMJE	Drug: Misoprostol 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion Drug: Placebo 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
Study Arm (s)	Experimental: misoprostol 400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion Intervention: Drug: Misoprostol Placebo Comparator: Placebo Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion Intervention: Drug: Placebo
Publications *	Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	61
Completion Date	April 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01001897
Other Study ID Numbers ^ICMJE	09004201
Has Data Monitoring Committee	Yes
Responsible Party	Pam Lotke, University of Arizona
Study Sponsor ^ICMJE	University of Arizona
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Arizona
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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