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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01147497
First Posted: June 22, 2010
Last Update Posted: March 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eva Lathrop, MD, Emory University
  Purpose
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

Condition Intervention
Contraception Drug: Misoprostol Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women

Resource links provided by NLM:


Further study details as provided by Eva Lathrop, MD, Emory University:

Primary Outcome Measures:
  • Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale [ Time Frame: assessed immediately post IUD insertion ]
    The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).


Secondary Outcome Measures:
  • Patient Perceived Pain on a 100 Point Visual Analogue Scale [ Time Frame: immediately after insertion ]
    The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).

  • The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD [ Time Frame: assessed immediately after IUD insertion ]
  • Time for Insertion Procedure [ Time Frame: assessed immediately after IUD insertion ]
  • Acceptability of Discomfort Associated With Insertion [ Time Frame: assessed at one week after insertion and at one month after insertion ]
  • Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women [ Time Frame: assessed immediately following insertion ]
  • Need for Additional Pain Medications After Insertion of the IUD [ Time Frame: assessed one week after insertion ]

Enrollment: 78
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: misoprostol
Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
Drug: Misoprostol
400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
Placebo Comparator: placebo
Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
Drug: Placebo
Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

Detailed Description:
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years
  • negative pregnancy test
  • no prior pregnancy beyond 19 6/7 weeks
  • no pelvic inflammatory disease in last 3 months
  • no current cervicitis
  • willing to follow up in 1-2 months

Exclusion Criteria:

  • active cervical infection
  • current pregnancy
  • prior pregnancy beyond 19 6/7 weeks
  • uterine anomaly
  • fibroid uterus distorting uterine cavity
  • copper allergy or wilson's disease for ParaGard
  • undiagnosed abnormal uterine bleeding
  • cervical or uterine cancer
  • sepsis associated with the most recent pregnancy
  • current breast cancer for levonogestrel IUD
  • inflammatory bowel disease
  • allergy to misoprostol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147497


Locations
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Eva Lathrop, MD, MPH Emory University School of Medicine, Department of Gynecology and Obstetrics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Lathrop, MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01147497     History of Changes
Other Study ID Numbers: IRB00021303
MISO Emory ( Other Identifier: Other )
First Submitted: June 15, 2010
First Posted: June 22, 2010
Results First Submitted: October 30, 2013
Results First Posted: March 24, 2014
Last Update Posted: March 24, 2014
Last Verified: February 2014

Keywords provided by Eva Lathrop, MD, Emory University:
IUD insertion
nulliparous women
contraception
family planning
IUD insertion in nulliparous women

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics