Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women (MPIIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah
ClinicalTrials.gov Identifier:
NCT00886834
First received: April 22, 2009
Last updated: December 21, 2011
Last verified: November 2011

April 22, 2009
December 21, 2011
April 2009
March 2011   (final data collection date for primary outcome measure)
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) [ Time Frame: Immediately post IUD insertion ] [ Designated as safety issue: No ]
VAS (anchors: 0 = extremely easy, 100 mm= impossible)
Provider perceived ease of insertion on a 100-point visual analogue scale [ Time Frame: Immediately post IUD insertion ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00886834 on ClinicalTrials.gov Archive Site
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) [ Time Frame: prior to insertion, immediately after insertion, and prior to clinic discharge ] [ Designated as safety issue: No ]
VAS; anchors: 0 =none, 100 mm= worst imaginable
  • Patient perceived pain on a 100-point visual analogue scale [ Time Frame: prior to insertion, immediately after insertion, and prior to clinic discharge ] [ Designated as safety issue: No ]
  • Ability to insert the IUD without the use of adjunctive measures including ultrasound guidance or cervical dilation [ Time Frame: During IUD insertion and immediately after ] [ Designated as safety issue: No ]
  • Time for IUD insertion procedure [ Time Frame: assessed immediately after IUD insertion ] [ Designated as safety issue: No ]
  • Presence of medication side effects [ Time Frame: assessed prior to IUD insertion, prior to leaving clinic and at 1 week follow-up ] [ Designated as safety issue: No ]
  • Procedure complications [ Time Frame: Assessed up to 1 month from time of IUD insertion ] [ Designated as safety issue: Yes ]
  • Need for additional pain medications the week following the procedure [ Time Frame: 1 week after IUD insertion ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women

The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Contraception
  • Drug: Misoprostol
    400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.
    Other Name: Cytotec
  • Drug: Placebo
    Pills which are identical to the study drug in appearance, taste, and smell.
  • Experimental: Misoprostol
    Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
    Intervention: Drug: Misoprostol
  • Placebo Comparator: Placebo
    Pills which are identical to the study drug in appearance, taste, and smell.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years old or older
  • negative pregnancy test
  • no prior pregnancies beyond 14 6/7 weeks
  • no PID in last 3 months
  • no current cervicitis
  • be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria:

  • active cervical infection
  • current pregnancy
  • prior pregnancy beyond 14 weeks gestation
  • known uterine anomaly
  • fibroid uterus distorting uterine cavity
  • copper allergy/Wilson's disease (for Paragard)
  • undiagnosed abnormal uterine bleeding
  • cervical or uterine cancer.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00886834
24403
Yes
David Turok, University of Utah
University of Utah
Not Provided
Principal Investigator: David Turok, MD/MPH University of Utah Department of Obstetrics and Gynecology
University of Utah
November 2011

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