NCT01147497

Brief Summary

Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

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

June 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 24, 2014

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

June 15, 2010

Results QC Date

October 30, 2013

Last Update Submit

January 10, 2018

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

    The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).

    assessed immediately post IUD insertion

Secondary Outcomes (6)

  • Patient Perceived Pain on a 100 Point Visual Analogue Scale

    immediately after insertion

  • The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD

    assessed immediately after IUD insertion

  • Time for Insertion Procedure

    assessed immediately after IUD insertion

  • Acceptability of Discomfort Associated With Insertion

    assessed at one week after insertion and at one month after insertion

  • Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women

    assessed immediately following insertion

  • +1 more secondary outcomes

Study Arms (2)

misoprostol

EXPERIMENTAL

Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit

Drug: Misoprostol

placebo

PLACEBO COMPARATOR

Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit

Drug: Placebo

Interventions

MisoprostolDRUG

400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit

misoprostol
PlaceboDRUG

Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

placebo

Eligibility Criteria

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

You may qualify if:

  • years
  • negative pregnancy test
  • no prior pregnancy beyond 19 6/7 weeks
  • no pelvic inflammatory disease in last 3 months
  • no current cervicitis
  • willing to follow up in 1-2 months

You may not qualify if:

  • active cervical infection
  • current pregnancy
  • prior pregnancy beyond 19 6/7 weeks
  • uterine anomaly
  • fibroid uterus distorting uterine cavity
  • copper allergy or wilson's disease for ParaGard
  • undiagnosed abnormal uterine bleeding
  • cervical or uterine cancer
  • sepsis associated with the most recent pregnancy
  • current breast cancer for levonogestrel IUD
  • inflammatory bowel disease
  • allergy to misoprostol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • Lathrop E, Haddad L, McWhorter CP, Goedken P. Self-administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial. Contraception. 2013 Dec;88(6):725-9. doi: 10.1016/j.contraception.2013.07.011. Epub 2013 Aug 6.

    PMID: 24034580DERIVED

  • 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
Eva Lathrop, MD, MPH
Organization
Emory University
elathro@emory.edu
404-778-1379

Study Officials

  • Eva Lathrop, MD, MPH

    Emory University School of Medicine, Department of Gynecology and Obstetrics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
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

June 15, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 12, 2018

Results First Posted

March 24, 2014

Record last verified: 2018-01

Locations

US(1)