Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of New Mexico.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eve Espey, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01307111
First received: March 1, 2011
Last updated: June 26, 2012
Last verified: June 2012

March 1, 2011
June 26, 2012
February 2011
February 2013   (final data collection date for primary outcome measure)
Provider perceived ease of insertion on a 100-point visual analogue scale. [ Time Frame: Immediately post IUD insertion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01307111 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Misoprostol
    400 micrograms inserted buccally or vaginally, per the participants desire.
  • Drug: Misoprostol
    400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
  • Experimental: Misoprostol
    Misoprostol 400 micrograms inserted buccally or vaginally, 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: Misoprostol
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. doi: 10.1186/1745-6215-12-104.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 14 years old or older
  • Negative pregnancy test
  • No prior pregnancies lasting beyond 19 6/7 weeks
  • Minimum 2 weeks after spontaneous or medical abortion
  • Minimum 4 weeks post 2nd trimester or surgical abortion
  • No previous IUD insertions
  • No PID in last 3 months
  • No current cervicitis
  • Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria:

  • Active cervical infection
  • Current pregnancy
  • Prior pregnancy beyond 19 6/7 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
14 Years to 45 Years
Yes
Contact: Eve Espey, MD/MPH 505-272-3942 eespey@salud.unm.edu
United States
 
NCT01307111
HRRC #09-426
Yes
Eve Espey, University of New Mexico
University of New Mexico
Not Provided
Principal Investigator: Eve Espey, MD/MPH University of New Mexico Department of Obstetrics and Gynecology
University of New Mexico
June 2012

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