Progesterone & Postpartum Relapse to Smoking
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | June 2016 |
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.
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.
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.
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
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