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Progesterone & Postpartum Relapse to Smoking


N/A
18 Years
35 Years
Not Enrolling
Female
Tobacco Use Cessation, Tobacco Use Disorder

Thank you

Trial Information

Progesterone & Postpartum Relapse to Smoking


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Relapse Rate

Outcome Description:

Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.

Outcome Time Frame:

Week 4 Postpartum

Safety Issue:

No

Principal Investigator

Sharon S. Allen, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2012NTLS059

NCT ID:

NCT01798394

Start Date:

March 2013

Completion Date:

June 2014

Related Keywords:

  • Tobacco Use Cessation
  • Tobacco Use Disorder
  • pregnant
  • smoker
  • cigarette
  • tobacco
  • Tobacco Use Disorder

Name

Location
University of Minnesota, 717 Delaware Street SE Minneapolis, Minnesota  55414