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Trial record 13 of 26 for:    Open Studies | "Intrauterine Devices"

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
  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

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 IUD Insertion for Nulliparous Women

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Provider perceived ease of insertion on a 100-point visual analogue scale. [ Time Frame: Immediately post IUD insertion ] [ Designated as safety issue: No ]

Secondary 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. ] [ 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 ]

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: March 2013
Estimated 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.
Placebo Comparator: Placebo
Pills which are identical to the study drug in appearance, taste, and smell.
Drug: Misoprostol
400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.

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

Ages Eligible for Study:   14 Years to 45 Years
Genders 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
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: NCT01307111

Contacts
Contact: Eve Espey, MD/MPH 505-272-3942 eespey@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Center for Reproductive Health Recruiting
Albuquerque, New Mexico, United States, 87112
Principal Investigator: Eve Espey, MD/MPH         
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

No publications provided by University of New Mexico

Additional 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
Study First Received: March 1, 2011
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of New Mexico:
Misoprostol
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