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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307111
First Posted: March 2, 2011
Last Update Posted: March 28, 2016
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):
Eve Espey, University of New Mexico
  Purpose
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.

Condition Intervention
Pain 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 IUD Insertion for Nulliparous Women

Resource links provided by NLM:


Further study details as provided by Eve Espey, University of New Mexico:

Primary Outcome Measures:
  • Patient Perceived Pain on a 100-point Visual Analogue Scale. [ Time Frame: Prior to insertion, immediately after insertion, and prior to clinic discharge. ]
    Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.


Secondary Outcome Measures:
  • Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale. [ Time Frame: Immediately post IUD insertion ]
    Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).


Enrollment: 85
Study Start Date: February 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Misoprostol
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.
Placebo Comparator: Placebo
Pills which are identical to the study drug in appearance, taste, and smell.
Drug: Placebo
Pills which are identical to the study drug in appearance, taste, and smell.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT01307111


Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Eve Espey, MD/MPH University of New Mexico Department of Obstetrics and Gynecology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eve Espey, Professor, OB-GYN, University of New Mexico
ClinicalTrials.gov Identifier: NCT01307111     History of Changes
Other Study ID Numbers: HRRC #09-426
First Submitted: March 1, 2011
First Posted: March 2, 2011
Results First Submitted: December 16, 2015
Results First Posted: March 28, 2016
Last Update Posted: March 28, 2016
Last Verified: February 2016

Keywords provided by Eve Espey, University of New Mexico:
Misoprostol
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