NCT01307111

Brief Summary

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable pain

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

February 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 28, 2016

Completed
Last Updated

March 28, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

March 1, 2011

Results QC Date

December 16, 2015

Last Update Submit

March 9, 2016

Conditions

Pain

Keywords

MisoprostolIUD insertionNulliparous WomenContraceptionFamily PlanningIUD insertion in nulliparous women

Outcome Measures

Primary Outcomes (1)

  • Patient Perceived Pain on a 100-point Visual Analogue Scale.

    Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.

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

Secondary Outcomes (1)

  • Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.

    Immediately post IUD insertion

Study Arms (2)

Misoprostol

EXPERIMENTAL

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

Misoprostol
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old or older
  • Negative pregnancy test
  • No prior pregnancies lasting beyond 19 6/7 weeks
  • Minimum 2 weeks after spontaneous or medical abortion
  • Minimum 4 weeks post 2nd trimester or surgical abortion
  • No previous IUD insertions
  • No PID in last 3 months
  • No current cervicitis
  • 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 19 6/7 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

Related Publications (1)

  • 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

Conditions

Pain

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Eve Espey, MD, MPH, Principle Investigator
Organization
University of New Mexico
eespey@salud.unm.edu
505-272-6372

Study Officials

  • Eve Espey, MD/MPH

    University of New Mexico 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
Professor, OB-GYN

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 28, 2016

Results First Posted

March 28, 2016

Record last verified: 2016-02