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

October 26, 2009
June 13, 2012
October 2009
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01001897 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women
A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Health Services Research
Contraception
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
April 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01001897
09004201
Yes
Pam Lotke, University of Arizona
University of Arizona
Not Provided
Not Provided
University of Arizona
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP