Increasing Contraception Utilization Among Women Prescribed Teratogenic Medications

NCT01624155 | Completed

• 1 other identifier: 111808
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Typically, the CTIS Pregnancy Health Information Line in the Department of Pediatrics, School of Medicine at the University of California educates pregnant women who call the Information Line after an exposure to a medication that might be harmful to the developing baby has already taken place, and therefore the opportunity for prevention of that exposure no longer exists. Frequently these pregnancies are unintended and occur due to the lack of effective contraceptive use. This study facilitates patient access at UCSD to specialized and individualized contraceptive counseling for women of reproductive age who are currently taking a medication that might be risky in a future pregnancy. This study also measures the impact of individualized contraceptive counseling in changing contraceptive behavior. Primary Hypothesis: EPIC (EMR)/physician-facilitated referral of female patients of reproductive age to an existing specialized counseling service at UCSD will improve the utilization of more effective contraception among women of reproductive age who are prescribed medications that might be harmful to the developing fetus.

Conditions

Teratogenesis

Keywords

teratogens; contraception; electronic medical record

Outcome Measures

Primary Outcomes (1)

• Change in Contraception Utilization

  Does specialized counseling improve (change) the utilization of more effective contraception among women in this population. We will measure the change in contraception utilization via a survey that participant will complete at each time frame.

  one week, one month, three months

Secondary Outcomes (1)

• Proportion of women identified through Electronic Medical Record who are able to be contacted of Electronic Medical Record Referral

  one week

Study Arms (1)

Women taking teratogens

EXPERIMENTAL

Women taking teratogens

Behavioral: Education

Interventions

Education BEHAVIORAL

EMR referral to teratogen and contraception counseling

Women taking teratogens

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age of participants: 18-45 years old
• Gender of participants: Female
• Ethnic Background: No limitation, will include minorities and Spanish speaking participants
• Health Status: no limitation
• Sexually active with men

You may not qualify if:

• Currently Pregnant
• Not sexually active with men
• History of hysterectomy
• Removal of both ovaries

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

Related Publications (1)

• Mody SK, Wu J, Ornelas M, Kernahan C, Salas E, Kao K, Felix R, Chambers C. Using the electronic medical record to refer women taking category D or X medications for teratogen and contraceptive counseling. Birth Defects Res A Clin Mol Teratol. 2015 Jul;103(7):644-7. doi: 10.1002/bdra.23396. Epub 2015 Jun 23.

  PMID: 26100297 DERIVED

MeSH Terms

Conditions

Teratogenesis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Sheila Mody, MD MPH

  University of California, San Diego

  STUDY DIRECTOR

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: Professor

Model Details: The patient is contacted by a specialist in the CTIS Pregnancy Health Information in the Department of Pediatrics at UCSD, and a brief patient interview is conducted with a risk assessment and counseling regarding her medication and the potential effects if she were to become pregnant. The patient is also given information about contraceptive methods, efficacy rates, and the safety of each method based on the USMEC guidance for the patient's medical condition. After the counseling is completed, the patient is asked if she is interested in participating in the research study. If the patient consents to participation, she is contacted one week, one month, and three months after the initial telephone interaction and asked several questions regarding her current contraceptive utilization and any changes from the time of the last interview. Upon completion of the three-month follow-up, participants are asked to complete a satisfaction survey.

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 20, 2012
• Study Start: January 5, 2012
• Primary Completion: October 30, 2013
• Study Completion: September 22, 2015
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

US (1)