NCT01001897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

October 26, 2009

Last Update Submit

June 13, 2012

Conditions

Contraception

Keywords

IUD insertionnulliparous womencontraception

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale

    after IUD insertion

Secondary Outcomes (6)

  • Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia

    during IUD insertion

  • Side effects of medications

    prior to IUD insertion

  • Provider perceived ease of insertion on a 100 mm visual analogue scale

    after IUD insertion

  • Acceptability of wait time prior to IUD placement

    1 week after IUD insertion

  • Procedure complications

    Up to 1 month after IUD placement

  • +1 more secondary outcomes

Study Arms (2)

misoprostol

EXPERIMENTAL

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

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MisoprostolDRUG

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

misoprostol
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UPH-Kino multispecialty clinic

Tucson, Arizona, 85713, United States

Location

University Medical Center Ob/Gyn clinic 8OPC

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

  • 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.

    PMID: 24215850DERIVED

  • 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.

    PMID: 21527040DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2011

Study Completion

April 1, 2011

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(2)