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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA034840 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone | Active Comparator | Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. |
|
| Placebo | Placebo Comparator | Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Relapsed by Week 4 Postpartum | 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. | Week 4 Postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Relapsed by Week 12 Postpartum | 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. | Week 12 Postpartum |
| Number of Participants Who Relapsed at All During Postpartum (up to Day 84) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon S. Allen, M.D., Ph.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, 717 Delaware Street SE | Minneapolis | Minnesota | 55414 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Progesterone | Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. |
| FG001 | Placebo | Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Progesterone | Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Relapsed by Week 4 Postpartum | 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. | Posted | Number | participants | Week 4 Postpartum |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progesterone | Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for post-cesarean section infection | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Tosun | University of Minnesota | 612-624-5439 | tosun004@umn.edu |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Placebo | Other | Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. |
|
Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse. |
| Postpartum Day 0 to 84 |
| Protocol Compliance - Number of Visits Attended | Compliance was measured as the number of visits attended (maximum of 5). | Gestational Week 36 - Postpartum Week 12 |
| Compliance Determinants | This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10. | Postpartum Week 12 |
| Protocol Compliance - Doses of Medication Taken | Compliance was measured by doses of medication taken (maximum of 56). | Postpartum Week 0 - Week 12 |
| Protocol Compliance - EDC's Completed | Compliance was measured as the number by number of EDCs completed (maximum of 84). | Gestational Week 36 - Postpartum Week 12 |
| Placebo |
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants Who Relapsed by Week 12 Postpartum | 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. | Posted | Number | participants | Week 12 Postpartum |
|
|
|
| Secondary | Number of Participants Who Relapsed at All During Postpartum (up to Day 84) | Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse. | Posted | Number | participants | Postpartum Day 0 to 84 |
|
|
|
| Secondary | Protocol Compliance - Number of Visits Attended | Compliance was measured as the number of visits attended (maximum of 5). | Posted | Mean | Standard Deviation | Number of visits attended | Gestational Week 36 - Postpartum Week 12 |
|
|
|
| Secondary | Compliance Determinants | This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10. | Posted | Mean | Standard Deviation | units on a scale | Postpartum Week 12 |
|
|
|
| Secondary | Protocol Compliance - Doses of Medication Taken | Compliance was measured by doses of medication taken (maximum of 56). | Posted | Mean | Standard Deviation | Doses of medication taken | Postpartum Week 0 - Week 12 |
|
|
|
| Secondary | Protocol Compliance - EDC's Completed | Compliance was measured as the number by number of EDCs completed (maximum of 84). | Posted | Mean | Standard Deviation | EDC's completed | Gestational Week 36 - Postpartum Week 12 |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Placebo | Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. | 1 | 22 | 0 | 22 |
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| D001523 |
| Mental Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |