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Progesterone & Postpartum Relapse to Smoking

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tobacco Use Cessation; Tobacco Use Disorder

Intervention: Progesterone (Drug); Placebo (Other)

Phase: N/A

Status: Recruiting

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
Sharon S. Allen, M.D., Ph.D., Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota

Overall contact:
Nicole L Tosun, M.S., Phone: 612-624-5350, Email: tosun004@umn.edu

Summary

The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

Clinical Details

Official title: Progesterone & Postpartum Relapse to Smoking

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Relapse Rate

Secondary outcome:

Relapse Rate

Days to Relapse

Protocol Compliance

Compliance Determinants

Detailed description: Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive 4 weeks of active or placebo exogenous progesterone starting on the 4th day postpartum. Participants will be in contact with study staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels and receive behavioral counseling.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pregnant women at 33-36 weeks gestation who have quit smoking during pregnancy

- Confirmed uncomplicated single-gestation pregnancy

- Established prenatal care

- English fluency

- Ability to provide informed consent

Locations and Contacts

Nicole L Tosun, M.S., Phone: 612-624-5350, Email: tosun004@umn.edu

University of Minnesota, 717 Delaware Street SE, Minneapolis, Minnesota 55414, United States; Recruiting
Nicole L. Tosun, M.S., Phone: 612-624-5350, Email: tosun004@umn.edu
Sharon S. Allen, M.D., Ph.D., Principal Investigator
Additional Information

Starting date: November 2013
Last updated: March 26, 2015

Page last updated: August 23, 2015

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