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Search / Trial NCT07129590

Trauma-Informed Care for Smoking Cessation for Pregnancy

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 11, 2025

Trial Information

Current as of August 24, 2025

Not yet recruiting

Keywords

Pregnancy

ClinConnect Summary

This clinical trial is studying a new way to help pregnant women stop smoking, especially those who have experienced trauma, such as distressing or difficult life events. The approach combines understanding trauma with proven methods for quitting smoking. Health care providers will use special techniques that recognize how trauma can affect a person and provide support that avoids making those feelings worse. This method, developed with community partners in San Francisco, is designed to better support pregnant women from diverse backgrounds who want to quit smoking.

Women who are eligible to join the study are pregnant, at least 18 years old, currently smoking, and have a history of trauma. They also need to speak English or Spanish and be able to safely participate. During the study, participants will work with trained health care professionals who will offer personalized help to quit smoking, following a step-by-step plan. The goal is to make quitting easier and safer by addressing both smoking and trauma together. If you fit these criteria and are interested, this study might offer extra support during your pregnancy to help you and your baby stay healthier.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Clinician Eligibility Criteria (Aims 1 - 3):
  • In Aim 1-3, will be recruiting clinicians working in the Obstetrics, Midwifery, and Gynecology Clinic (5M) safety-net clinic.
  • 1. Nurse practitioner, physician assistant, nurse-midwife, or medical doctor caring for pregnant patient-participants.
  • 2. Age ≥ 18 years old.
  • Patient-participant Eligibility Criteria (Aims 1 \& 3):
  • 1. Currently smoking (ever smoked 100 cigarettes in their lifetime, smoked in the past 7 days and at least 1 cigarette per day, verified by CO≥6ppm)
  • 2. Age ≥18 years old.
  • 3. Currently Pregnant.
  • 4. Identifies as a cisgender woman, or female at birth.
  • 5. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ).
  • 6. Proficient in English or Spanish languages.
  • Patient-Participant Eligibility Criteria (Aims 2):
  • Patient-participants from the 5M advisory boards will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.
  • Inclusion criteria:
  • 1. Participant in a 5M Clinic Patient Advisory Board.
  • 2. Age ≥18 years old.
  • 3. Proficient in English or Spanish languages.
  • Exclusion Criteria:
  • Clinician- and Patient-participant Exclusion criteria (Aims 1 - 3):
  • 1. Any condition, including active mental health crises or cognitive impairment, that would interfere with the ability to provide informed consent or safely complete the study.

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Anita Hargrave-Bouagnon, MD, MAS

Principal Investigator

University of California, San Francisco

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported