Progesterone for Postpartum Smoking Relapse

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sharon Allen, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Minnesota

Must not be taking: Nicotine replacement, Smoking cessation

Disqualifiers: Depression, Drug use, Heart disease, others

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.

Will 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.

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. ^{1 2 3 4 5}

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. ^{3 5 6 7 8}

Research Team

Sharon Allen, MD

Principal Investigator

University of Minnesota

Eligibility 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

established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider

I agree to use non-hormonal birth control after giving birth until 12 weeks later.

I am 30-35 weeks pregnant and both my mental and physical health are stable.

Exclusion Criteria

any condition that, in the opinion of the clinical team, precludes participation in the trial.

You have received treatment for drug or alcohol addiction within the last three months.

I am not using aminoglutethimide or planning to get pregnant soon.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants living in Minnesota will receive a 12-week course of exogenous progesterone

12 weeks

Remote visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including self-administered surveys and self-collection of dried blood spots

6 months

Remote visits

Treatment Details

Interventions

• Depot-Medroxyprogestereone Acetate (Progestin)
• Placebo Injection (Other)
• Placebo Oral Tablet (Other)
• Progesterone 200 MG Oral Capsule (Progestin)

Trial Overview 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.

Participant Groups

Group I: Group 2 Active Control 1 Intervention

Participants in this group will not receive progesterone

Group II: Group 1 Active Control 1 Intervention

Participants in this group will receive progesterone

Depot-Medroxyprogestereone Acetate is already approved in Canada for the following indications:

Approved in Canada as Depo-Provera for:

• Contraception
• Endometriosis
• Renal carcinoma
• Cervical carcinoma
• Adenocarcinoma of the breast

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

Depot medroxyprogesterone acetate (DMPA) is a highly effective contraceptive method, with no pregnancies reported within three months of injection among 363 women treated over 20 years, and a high acceptability rate with an average of 6.3 injections per subject.

While some women experienced menstrual disturbances, only 7.3% discontinued due to these issues, and the median delay in return to fertility for those wishing to conceive was 9.2 months, indicating that DMPA is generally safe and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depo-Provera use in an Australian metropolitan practice. Fraser, IS., Dennerstein, GJ.[2015]

In a study of 5,073 women, the use of postpartum depot medroxyprogesterone acetate (DMPA) was not linked to an increase in postpartum depressive symptoms, as indicated by the Patient Health Questionnaire 9 (PHQ-9) screening results.

Despite previous concerns about DMPA potentially causing depression, this research suggests that its use in the immediate postpartum period is safe and should not deter women from using it as a contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between Immediate Postpartum Depot Medroxyprogesterone Acetate Use and Postpartum Depressive Symptoms. Ross, CM., Shim, JY., Stark, EL., et al.[2023]

In a study of 1864 New Zealand women aged 25 to 54, 13.7% reported using depot medroxyprogesterone acetate (DMPA) as a contraceptive, with higher usage among Maori women and those with lower income and education levels.

While DMPA has a low contraceptive failure rate of 0.9 per 100 woman-years, many users discontinue due to side effects like menstrual disturbances and weight gain, indicating that its acceptability is limited despite its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depot medroxyprogesterone acetate. Patterns of use and reasons for discontinuation. Paul, C., Skegg, DC., Williams, S.[2019]

A pooled analysis of two case-control studies involving 1,768 women with breast cancer and 13,905 controls found that the overall relative risk (RR) of breast cancer for women who had ever used depot medroxyprogesterone acetate (DMPA) was 1.1, indicating no significant increase in risk.

However, recent or current users of DMPA (within the last 5 years) had a higher estimated RR of 2.0, suggesting that the increased risk may be related to enhanced detection of tumors or accelerated growth of existing tumors, while women who used DMPA more than 5 years ago showed no increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depot medroxyprogesterone acetate and breast cancer. A pooled analysis of the World Health Organization and New Zealand studies. Skegg, DC., Noonan, EA., Paul, C., et al.[2022]

The study involving 183 mothers assessed the impact of immediate postpartum depot medroxyprogesterone (DMPA) on breastfeeding duration, suggesting a potential negative effect, although it was not statistically significant (p=0.24).

After adjusting for confounding factors, the hazard ratio indicated a 22% higher risk of breastfeeding cessation associated with DMPA use, but the evidence remains inconclusive, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of immediate postpartum depot medroxyprogesterone on early breastfeeding cessation. Brownell, EA., Fernandez, ID., Fisher, SG., et al.[2021]

Among low-income new mothers in upstate New York, 31.3% received postpartum DMPA, with 62.6% of those receiving it before hospital discharge, highlighting the importance of timely administration to prevent unintended pregnancies.

The study found significant variability in DMPA administration patterns across different hospitals, suggesting a need for further research to improve access and ensure appropriate candidates receive this contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of postpartum depot medroxyprogesterone administration among low-income mothers. Dozier, AM., Nelson, A., Brownell, EA., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Depo-Provera use in an Australian metropolitan practice. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Retrospective review of the relationship between weight change and demographic factors following initial depot medroxyprogesterone acetate injection in adolescents. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

The Association between Immediate Postpartum Depot Medroxyprogesterone Acetate Use and Postpartum Depressive Symptoms. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Depot medroxyprogesterone acetate. Patterns of use and reasons for discontinuation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Depot medroxyprogesterone acetate and breast cancer. A pooled analysis of the World Health Organization and New Zealand studies. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of depot medroxyprogesterone acetate on postpartum depression. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

The effect of immediate postpartum depot medroxyprogesterone on early breastfeeding cessation. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Patterns of postpartum depot medroxyprogesterone administration among low-income mothers. [2022]