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

NCT ID: NCT01001897

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-04-30

Brief Summary

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.

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

misoprostol

400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Placebo

Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Interventions

Misoprostol

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Intervention Type: DRUG

Placebo

400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Pam Lotke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UPH-Kino multispecialty clinic

Tucson, Arizona, United States

University Medical Center Ob/Gyn clinic 8OPC

Tucson, Arizona, United States

Countries

United States

References

Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial. Am J Obstet Gynecol. 2014 Mar;210(3):208.e1-5. doi: 10.1016/j.ajog.2013.11.018. Epub 2013 Nov 8.

Reference Type: DERIVED

PMID: 24215850 (View on PubMed)

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. doi: 10.1186/1745-6215-12-104.

Reference Type: DERIVED

PMID: 21527040 (View on PubMed)

Other Identifiers

09004201

Identifier Type: -

Identifier Source: org_study_id