Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pam Lotke, University of Arizona
ClinicalTrials.gov Identifier:
NCT01001897
First received: October 26, 2009
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.


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)
Primary Purpose: Health Services Research
Official Title: A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale [ Time Frame: after IUD insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia [ Time Frame: during IUD insertion ] [ Designated as safety issue: No ]
  • Side effects of medications [ Time Frame: prior to IUD insertion ] [ Designated as safety issue: No ]
  • Provider perceived ease of insertion on a 100 mm visual analogue scale [ Time Frame: after IUD insertion ] [ Designated as safety issue: No ]
  • Acceptability of wait time prior to IUD placement [ Time Frame: 1 week after IUD insertion ] [ Designated as safety issue: No ]
  • Procedure complications [ Time Frame: Up to 1 month after IUD placement ] [ Designated as safety issue: Yes ]
  • Acceptability of total IUD placement process, would you recommend this to a friend? [ Time Frame: 1 week and 1 month after IUD insertion ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: misoprostol
400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion
Drug: Misoprostol
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
Placebo Comparator: Placebo
Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion
Drug: Placebo
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Detailed Description:

IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nulliparous, no prior pregnancy beyond 14 week
  • Over 18 years of age
  • Negative pregnancy test

Exclusion Criteria:

  • current pregnancy or pregnancy within 6 weeks
  • current cervicitis or PID (active or within 3 months)
  • undiagnosed abnormal uterine bleeding
  • allergy to copper/ Wilson's disease (for Paragard)
  • cervical or uterine cancer
  • uterine anomaly altering uterine cavity
  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: NCT01001897

Locations
United States, Arizona
University Medical Center Ob/Gyn clinic 8OPC
Tucson, Arizona, United States, 85724
UPH-Kino multispecialty clinic
Tucson, Arizona, United States, 85713
Sponsors and Collaborators
University of Arizona
  More Information

No publications provided by University of Arizona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pam Lotke, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT01001897     History of Changes
Other Study ID Numbers: 09004201
Study First Received: October 26, 2009
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
IUD insertion
nulliparous women
contraception

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 October 22, 2014