NCT02293213

Brief Summary

Investigators propose a randomized controlled trial of women taking category D or X medications seen in family medicine, internal medicine or in the Coumadin Clinic. Women in the intervention group will receive an electronic medical record referral for teratogen counseling and contraceptive counseling with a follow up contraceptive provision appointment. The contraceptive counseling will be adapted from The Contraceptive CHOICE Project script and promote the use of the long acting reversible contraception. The women in the control group will also receive an electronic medical record referral and receive the teratogen counseling but only be told that it is important to avoid becoming pregnant. An initial survey will assess contraceptive knowledge and utilization. In addition, there will be telephone survey at 3 months and 6 months to assess contraceptive utilization and continuation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

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

April 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

November 13, 2014

Last Update Submit

June 6, 2019

Conditions

Chemical Teratogen ExposureContraception BehaviorContraception

Keywords

Category DCategory XElectronic Medical RecordsLong Acting Reversible Contraception

Outcome Measures

Primary Outcomes (1)

  • Utilization of More Effective Contraception

    Change of contraception from baseline questionnaire compared to 3 and 6 month follow up with improved contraception defined as 1) no contraception changed to some form of contraception, 2) barrier methods changed to combined hormonal contraception/ IUD/contraceptive implant/tubal ligation, or 3) combined hormonal method to an IUD/contraceptive implant/tubal ligation.

    1 year

Study Arms (2)

Counseling only

ACTIVE COMPARATOR

All participants who receive EMR referral to CTIS because they are taking class D or X medications AND are randomized to counseling only will receive: CTIS Counseling, Baseline Questionnaire, 3 Month Follow up Questionnaire, and 6 Month Follow up Questionnaire.

Behavioral: EMR ReferralBehavioral: CTIS CounselingBehavioral: Baseline QuestionnaireBehavioral: 3 Month Follow Up QuestionnaireBehavioral: 6 Month Follow Up Questionnaire

Counseling + Contraception Appointment

EXPERIMENTAL

All participants who receive EMR referral to CTIS because they are taking class D or X medications AND are randomized to counseling + Contraception Appointment will receive: CTIS Counseling, Baseline Questionnaire, Contraception Provision Appointment, 3 Month Follow up Questionnaire, and 6 Month Follow up Questionnaire.

Behavioral: EMR ReferralBehavioral: CTIS CounselingBehavioral: Baseline QuestionnaireBehavioral: Contraception Provision AppointmentBehavioral: 3 Month Follow Up QuestionnaireBehavioral: 6 Month Follow Up Questionnaire

Interventions

EMR ReferralBEHAVIORAL

EMR referral to California Teratogen Information Services (CTIS) for use of category D or X medication.

Counseling + Contraception AppointmentCounseling only
CTIS CounselingBEHAVIORAL

Counseling from MotherToBaby teratogen information specialist.

Counseling + Contraception AppointmentCounseling only
Baseline QuestionnaireBEHAVIORAL

Baseline Questionnaire capturing contraceptive use immediately after counseling with MotherToBaby

Counseling + Contraception AppointmentCounseling only
Contraception Provision AppointmentBEHAVIORAL

Appointment with contraception provider to discuss contraception options.

Counseling + Contraception Appointment
3 Month Follow Up QuestionnaireBEHAVIORAL

Questionnaire 3 months after CTIS counseling to assess contraception use and plans

Counseling + Contraception AppointmentCounseling only
6 Month Follow Up QuestionnaireBEHAVIORAL

Questionnaire 6 months after CTIS counseling to assess contraception use and plans

Counseling + Contraception AppointmentCounseling only

Eligibility Criteria

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

You may qualify if:

  • Ethnic Background: No limitation, will include minorities and Spanish speaking participants
  • Health Status: no limitation
  • Sexually active with men
  • Currently taking the Category D or X medication

You may not qualify if:

  • Currently Pregnant
  • Not currently sexually active with men
  • History of hysterectomy, bilateral oophorectomy, history of female sterilization
  • Partner with history of vasectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTIS Pregnancy Health Information Line at the University of California San Diego

San Diego, California, 92123, United States

Location

Related Publications (5)

  • Santucci AK, Gold MA, Akers AY, Borrero S, Schwarz EB. Women's perspectives on counseling about risks for medication-induced birth defects. Birth Defects Res A Clin Mol Teratol. 2010 Jan;88(1):64-9. doi: 10.1002/bdra.20618.

    PMID: 19637252BACKGROUND

  • Eisenberg DL, Stika C, Desai A, Baker D, Yost KJ. Providing contraception for women taking potentially teratogenic medications: a survey of internal medicine physicians' knowledge, attitudes and barriers. J Gen Intern Med. 2010 Apr;25(4):291-7. doi: 10.1007/s11606-009-1215-2. Epub 2010 Jan 20.

    PMID: 20087677BACKGROUND

  • Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. Natl Health Stat Report. 2012 Oct 18;(60):1-25.

    PMID: 24988814BACKGROUND

  • Trussell J. Contraceptive failure in the United States. Contraception. 2011 May;83(5):397-404. doi: 10.1016/j.contraception.2011.01.021. Epub 2011 Mar 12.

    PMID: 21477680BACKGROUND

  • Steinkellner A, Chen W, Denison SE. Adherence to oral contraception in women on Category X medications. Am J Med. 2010 Oct;123(10):929-934.e1. doi: 10.1016/j.amjmed.2010.05.009.

    PMID: 20920695BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sheila Mody, MD MPH

    UCSD Department of Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 18, 2014

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations

US(1)