NCT02292056

Brief Summary

There is currently limited research that addresses the unique medication safety and family planning needs among women of reproductive age with psychiatric conditions. The study will research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford Clinic in the Department of Psychiatry at UCSD that will help women in this population better understand: 1) which of their medications are safe to use in pregnancy, 2) provide education regarding the importance of using contraception and which contraceptive choices are available to them, and 3) raise awareness of any drug-drug interactions that may exist between their medications and their chosen method of contraception. Patients will be given questionnaire to assess their contraceptive utilization. They will also be given a before and after quiz to allow for an objective measure of the patient's increase in knowledge regarding medication safety and contraceptive choices as a result of the investigators intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

2.1 years

First QC Date

November 12, 2014

Last Update Submit

November 14, 2014

Conditions

Mental DisordersContraceptionChemical Teratogen Exposure

Outcome Measures

Primary Outcomes (1)

  • Increase in Patient Knowledge

    Assessed with score delta between Pre-counseling and Post-counseling Quizzes

    1 year

Secondary Outcomes (3)

  • Contraceptive Plans

    1 year

  • Utilization of Contraception

    1 year

  • Baseline Medication Safety Knowledge

    1 year

Study Arms (1)

Counseling Group

EXPERIMENTAL

Participation in the study will be completed in a single session and will involve a pre-counseling questionnaire, followed by a pre-counseling quiz, individualized counseling session, post-counseling quiz and post-counseling questionnaire.

Behavioral: 1-on-1 counseling

Interventions

1-on-1 counselingBEHAVIORAL

1. Precounseling questionnaire collecting demographic information, contraception information, and reasons for choosing contraceptive method 2. Precounseling quiz: assess baseline level of knowledge regarding medication safety and contraceptive option. 3. Counseling: completed by MotherToBaby counselor about the safety of their medications for use in pregnancy. 4. 10 minute video entitled "The Contraceptive Choice Project: Which Birth Control Method is Right for You?" by Washington University in St. Louis. 5. Post-Counseling Quiz to assess whether specialized training impacted their understanding of medication safety and contraceptive options. 6. Post-Counseling Questionnaire: assess contraceptive plans and satisfaction with counseling

Counseling Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presenting for follow up psychiatric visit
  • Ethnic Background: will include only english speaking participants (MotherToBaby counselors are only able to speak English)
  • Level of Education: No limitation
  • Health Status: at least one psychiatric condition for which they are taking medication
  • Sexually active with Men

You may not qualify if:

  • Planning to become pregnant
  • Not sexually active with men
  • History of hysterectomy, bilateral oophorectomy, or surgical sterilization
  • Decisionally impaired - using post-consent instrument to assess decisional capacity. If a potential participant does not score 100% on post-consent instrument, then she will be excluded from participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gifford Clinic at UCSD Outpatient Psychiatry

San Diego, California, 92103, United States

RECRUITING

Related Publications (7)

  • Trussell J, Wynn LL. Reducing unintended pregnancy in the United States. Contraception. 2008 Jan;77(1):1-5. doi: 10.1016/j.contraception.2007.09.001. Epub 2007 Dec 3. No abstract available.

    PMID: 18082659BACKGROUND

  • Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat 23. 2005 Dec;(25):1-160.

    PMID: 16532609BACKGROUND

  • Curtis V. Women are not the same as men: specific clinical issues for female patients with bipolar disorder. Bipolar Disord. 2005;7 Suppl 1:16-24. doi: 10.1111/j.1399-5618.2005.00190.x.

    PMID: 15762865BACKGROUND

  • Guedes TG, Moura ER, Almeida PC. Particularities of family planning in women with mental disorders. Rev Lat Am Enfermagem. 2009 Sep-Oct;17(5):639-44. doi: 10.1590/s0104-11692009000500007.

    PMID: 19967211BACKGROUND

  • CDC. U.S. medical eligibility criteria for contraceptive use, 2010: adapted from the World Health Organization medical eligibility criteria for contraceptive use, 4th edition. MMWR 2010;59 (No. RR-4)

    BACKGROUND

  • Crawford P. Interactions between antiepileptic drugs and hormonal contraception. CNS Drugs. 2002;16(4):263-72. doi: 10.2165/00023210-200216040-00005.

    PMID: 11945109BACKGROUND

  • Committee opinion no. 505: understanding and using the U.S. Medical Eligibility Criteria For Contraceptive Use, 2010. Obstet Gynecol. 2011 Sep;118(3):754-760. doi: 10.1097/AOG.0b013e3182310cd3.

    PMID: 21860318BACKGROUND

Related Links

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Sheila Mody, MD MPH

    UCSD Department of Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Mody, MD MPH

CONTACT

619-543-6777smody@ucsd.edu

Study Design

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

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

September 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

US(1)