Progesterone for Postpartum Smoking Relapse
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Minnesota
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The investigators aim to address the following specific aims:
* Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors.
* Examine the effects of this maternal smoking intervention on infant health.
* Examine racial and ethnic differences in intervention outcomes.
Is progesterone treatment generally safe for humans?
Depot medroxyprogesterone acetate (DMPA), a form of progesterone, is widely used as a contraceptive, but some users report side effects like menstrual disturbances and weight gain. There are also concerns about its association with depressive symptoms and breast cancer, though the evidence is not conclusive.
12358Will I have to stop taking my current medications?
The trial requires that you do not use nicotine replacement therapy or smoking cessation medications, except for e-cigarettes. Also, you cannot participate if you are taking drugs that may interfere with progesterone treatment.
How is the drug Progesterone for Postpartum Smoking Relapse different from other treatments?
This treatment is unique because it uses depot medroxyprogesterone acetate (DMPA), a long-acting form of progesterone, which is typically used for contraception and may influence hormonal changes postpartum. Unlike other treatments for smoking relapse, it is administered as an injection, which provides a sustained release of the hormone, potentially affecting mood and behavior related to smoking.
14678Eligibility Criteria
This trial is for women in stable health who are 30-35 weeks pregnant, have quit smoking for at least 4 weeks, and are motivated to stay smoke-free postpartum. They must not be planning pregnancy soon after delivery, using illicit drugs or alcohol excessively, or have certain medical conditions like heart disease or a history of blood clots.Inclusion Criteria
I have smoked at least 5 cigarettes daily for 6 months in the past year.
Exclusion Criteria
I am not using aminoglutethimide or planning to get pregnant soon.
I cannot take progesterone due to a health condition or medication I am on.
I am currently using tobacco products or nicotine replacement therapy.
I have been diagnosed with major depression.
Participant Groups
The study tests if Progesterone (a hormone capsule) can help new moms avoid starting smoking again after giving birth compared to a placebo (a dummy pill). It also looks at how this might benefit the baby's health and explores if there are differences in outcomes based on race and ethnicity.
2Treatment groups
Active Control
Group I: Group 2Active Control1 Intervention
Participants in this group will not receive progesterone
Group II: Group 1Active Control1 Intervention
Participants in this group will receive progesterone
Depot-Medroxyprogestereone Acetate is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Depo-Provera for:
- Contraception
- Endometriosis
- Renal carcinoma
- Cervical carcinoma
- Adenocarcinoma of the breast
🇪🇺 Approved in European Union as Depo-Provera for:
- Contraception
- Endometriosis
- Renal carcinoma
- Cervical carcinoma
- Adenocarcinoma of the breast
🇨🇦 Approved in Canada as Depo-Provera for:
- Contraception
- Endometriosis
- Renal carcinoma
- Cervical carcinoma
- Adenocarcinoma of the breast
🇦🇺 Approved in Australia as Depo-Provera for:
- Contraception
- Endometriosis
- Renal carcinoma
- Cervical carcinoma
- Adenocarcinoma of the breast
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of ArizonaTucson, AZ
University of MinnesotaMinneapolis, MN
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
University of ArizonaCollaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Depot medroxyprogesterone acetate and breast cancer. A pooled analysis of the World Health Organization and New Zealand studies. [2022]Although depot medroxyprogesterone acetate (DMPA) (Depo-Provera) has now been approved for marketing as a contraceptive in the United States, there are still unresolved issues about the relation between DMPA and risk of breast cancer. The two substantial case-control studies of this association yielded similar but inconclusive results. Because their designs were compatible, these studies were pooled to obtain more adequate data for analysis.
Depo-Provera use in an Australian metropolitan practice. [2015]To review the characteristics and experience of Australian women treated with depot medroxyprogesterone acetate (DMPA) in one gynaecological practice in Melbourne since 1973.
Depot medroxyprogesterone acetate. Patterns of use and reasons for discontinuation. [2019]Little information is available from outside clinic settings about the acceptability of depot medroxyprogesterone acetate (DMPA, Depo-Provera) as an injectable contraceptive. In this national, population-based study, New Zealand women aged 25 to 54 years were selected at random from voter rolls. The 1864 subjects were interviewed by telephone after an initial approach by letter. More than 1 in 8 women (13.7%) had used DMPA at some time. The proportion was higher among Maori women and among those of lower income and education, but DMPA had been used by a substantial proportion of all socioeconomic groups. A quarter of all users reported receiving only a single injection of DMPA, and only 53% had used this method for a total of 12 months or more. Only 5 (1.6%) of discontinuations were attributed to contraceptive failure; this corresponds to a contraceptive failure rate of 0.9 per 100 woman-years. Side effects were given as the most common reasons for stopping, with menstrual disturbances and weight gain being cited most often. Other reasons for stopping included no further need for contraception or doubts about the appropriateness of DMPA. In this developed country population, DMPA is widely used for short periods but its acceptability is limited by the occurrence of side effects.
Effect of depot medroxyprogesterone acetate on postpartum depression. [2015]Depot medroxyprogesterone acetate (DMPA) is commonly prescribed to women immediately postpartum due to its efficacy, convenience and lack of estrogen. It is unclear whether administering a progestin injection can affect the course of postpartum depression (PPD), which some suspect to be influenced by hormonal changes. In this retrospective study, the objective was to determine whether DMPA administered immediately postpartum influences the development of PPD.
Retrospective review of the relationship between weight change and demographic factors following initial depot medroxyprogesterone acetate injection in adolescents. [2013]Depot medroxyprogesterone acetate (DMPA) is an effective (
The effect of immediate postpartum depot medroxyprogesterone on early breastfeeding cessation. [2021]This study evaluated the effect of immediate postpartum depot medroxyprogesterone (DMPA) on breastfeeding cessation within 6 weeks postpartum.
Patterns of postpartum depot medroxyprogesterone administration among low-income mothers. [2022]Depot medroxyprogesterone acetate (DMPA) is often administered immediately postpartum to reduce the risk of short-interval repeat or unintended pregnancies, but little is known about the actual patterns of postpartum DMPA use. This article examines the patterns of DMPA administered among low-income new mothers in an upstate New York State community.
The Association between Immediate Postpartum Depot Medroxyprogesterone Acetate Use and Postpartum Depressive Symptoms. [2023]While postpartum depot medroxyprogesterone acetate (DMPA) is a highly effective form of contraception, some data suggest an association with depressive symptoms. Our objective was to evaluate the relationship between receipt of DMPA in the immediate postpartum period and postpartum depressive symptoms.