NCT00886834

Brief Summary

The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

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

April 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 22, 2011

Completed
Last Updated

December 22, 2014

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

April 22, 2009

Results QC Date

August 5, 2011

Last Update Submit

December 4, 2014

Conditions

Contraception

Keywords

IUD insertionNulliparous womenContraceptionFamily PlanningIUD insertion in nulliparous women

Outcome Measures

Primary Outcomes (1)

  • Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)

    VAS (anchors: 0 = extremely easy, 100 mm= impossible)

    Immediately post IUD insertion

Secondary Outcomes (1)

  • Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)

    prior to insertion, immediately after insertion, and prior to clinic discharge

Study Arms (2)

Misoprostol

EXPERIMENTAL

Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

Pills which are identical to the study drug in appearance, taste, and smell.

Drug: Placebo

Interventions

MisoprostolDRUG

400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.

Also known as: Cytotec
Misoprostol
PlaceboDRUG

Pills which are identical to the study drug in appearance, taste, and smell.

Placebo

Eligibility Criteria

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

You may qualify if:

  • years old or older
  • negative pregnancy test
  • no prior pregnancies beyond 14 6/7 weeks
  • no PID in last 3 months
  • no current cervicitis
  • be willing to follow-up in 1-2 months for an IUD string check.

You may not qualify if:

  • active cervical infection
  • current pregnancy
  • prior pregnancy beyond 14 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84111, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

  • Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9.

    PMID: 22825094DERIVED

  • 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

Results Point of Contact

Title
Dr. David Turok
Organization
University of Utah, Department of Obstetrics and Gynecology
david.turok@hsc.utah.edu
801-581-7647

Study Officials

  • David Turok, MD/MPH

    University of Utah Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 22, 2014

Results First Posted

December 22, 2011

Record last verified: 2014-12

Locations

US(2)