Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women - Full Text View

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:

MedlinePlus related topics: Birth Control

Drug Information available for: Misoprostol

U.S. FDA Resources

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

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):

Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104.

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
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on June 18, 2013