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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD100418 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The investigators aim to address the following specific aims:
This Good Clinical Practice clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators to enhance the diversity of the study sample and generalizability of results. We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US) and will participant in an observational arm of the study. Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. All participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Participants in this group will receive progesterone |
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| Group 2 | No Intervention | Participants in this group will not receive progesterone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone 200 MG Oral Capsule | Drug | Progesterone, 200mg, once daily, oral tablet/capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Smoking abstinence at Month 6 | 6 months | |
| Child health assessed as smoke exposure and acute infant health. | 6 months |
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Inclusion Criteria:
Ability to provide informed consent,
Aged 18 to 45 years old
Self-reported stable physical and mental health
History of ≥ 4 cigarettes per month during the six months prior to pregnancy
At enrollment, self-report of motivation to become and/or remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale
Willingness to protect against pregnancy following day 0 to week 12 of the study
Participants must live in the continental US and have a device to fully participate in the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Allen, MD, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39618477 | Derived | Abdelwahab N, Allen A, Harrison K, Petersen A, Allen S. A protocol for modifying progesterone to increase postpartum cigarette smoking abstinence and reduce secondhand smoke exposure in infants. Contemp Clin Trials Commun. 2024 Nov 6;42:101389. doi: 10.1016/j.conctc.2024.101389. eCollection 2024 Dec. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D000074264 | Smoking Reduction |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | 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 |
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