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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eva Lathrop, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01147497
First received: June 15, 2010
Last updated: February 24, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Emory University:

Primary Outcome Measures:
  • Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale [ Time Frame: assessed immediately post IUD insertion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time for Insertion Procedure [ Time Frame: assessed immediately after IUD insertion ] [ Designated as safety issue: No ]
  • Acceptability of Discomfort Associated With Insertion [ Time Frame: assessed at one week after insertion and at one month after insertion ] [ Designated as safety issue: No ]
  • Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women [ Time Frame: assessed immediately following insertion ] [ Designated as safety issue: No ]
  • Need for Additional Pain Medications After Insertion of the IUD [ Time Frame: assessed one week after insertion ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Emory University

Additional 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
Study First Received: June 15, 2010
Results First Received: October 30, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
IUD insertion
nulliparous women
contraception
family planning
IUD insertion in nulliparous women

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

ClinicalTrials.gov processed this record on November 20, 2014