Stress Management for Pregnancy

Recruiting in Palo Alto (17 mi)

Overseen by Gesulla Cavanaugh, PhD, MPH, MS

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nova Southeastern University

Disqualifiers: Less than 24 weeks, high risk

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Simulated stimuli, Stress Management, Stress Reduction, Anxiety Management, Prenatal Stress Intervention for managing stress during pregnancy?

Research suggests that relaxation techniques can help reduce stress and anxiety in pregnant women, which is important because stress during pregnancy can negatively affect both the mother and the baby's health. ^{1 2 3 4 5}

Is stress management safe for pregnant women?

The research articles provided do not contain specific safety data on stress management techniques for pregnant women. However, they highlight the general lack of safety data for various treatments during pregnancy, emphasizing the need for more research in this area. ^{6 7 8 9 10}

How is the Stress Management treatment for pregnancy different from other treatments?

Stress Management for pregnancy is unique because it focuses on non-drug approaches like mind-body interventions, which are designed to reduce anxiety and stress without medication. This is particularly important during pregnancy, as it avoids potential side effects of drugs and addresses emotional well-being, which is often overlooked in prenatal care. ^{1 2 3 11 12}

Research Team

Gesulla Cavanaugh, PhD, MPH, MS

Principal Investigator

Nova Southeastern University

Eligibility Criteria

This trial is for pregnant women who are at least 24 weeks into their pregnancy and aged between 21 to 37 years. It's not suitable for those less than 24 weeks pregnant or with high-risk pregnancies.

Inclusion Criteria

In 24 weeks gestation or more

I am between 21 and 37 years old.

Exclusion Criteria

In less than 24 weeks gestation

High risk pregnancies

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stress Exposure and Management

Participants are exposed to a mild stressful stimulus and a relaxant to record physiological responses, followed by practicing stress management techniques at home for one week.

1 week

1 visit (in-person) for initial data collection

Follow-up

Participants are monitored for changes in stress levels as assessed by salivary cortisol levels.

4-8 weeks

Treatment Details

Interventions

• Simulated stimuli (Behavioral Intervention)
• Stress Management (Behavioral Intervention)

Trial Overview The study investigates how stress management techniques and simulated stimuli can help mitigate the effects of chronic stress in pregnant women, aiming to improve prenatal care and reduce complications.

Participant Groups

Group I: Stress Exposure and Management Experimental Treatment 2 Interventions

All pregnant participants will be exposed to a 50 second-mild stressful stimulus and a 50 second- relaxant to record physiological responses. The participants will then independently practice easy stress management techniques at home, such as breathing and listening to music. They will do so for one week after the initial data collection.

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Dr. George L. Hanbury II

Nova Southeastern University

Chief Executive Officer since 2011

PhD in Higher Education Administration from Nova Southeastern University

Dr. Gary S. Margules

Nova Southeastern University

Chief Medical Officer since 2010

MD from University of Miami

Findings from Research

Provider-based stress-reducing interventions during pregnancy, such as skills-building, mindfulness, behavioral therapy, and group support, can improve mood and reduce stress among pregnant individuals, particularly those from marginalized communities.

The review analyzed 23 studies and found that while the overall effectiveness of these interventions varies, group-based therapies that combine multiple approaches tend to be more beneficial in addressing maternal stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. Moore, N., Abouhala, S., Maleki, P., et al.[2023]

The study involving 33 fetuses found that maternal relaxation techniques, particularly guided imagery (GI), positively influenced fetal behavior, with increased long-term heart rate variation compared to a control group.

Women practicing progressive muscle relaxation (PMR) exhibited more uterine activity than those using GI or the control group, suggesting that different relaxation methods may have varying effects on maternal and fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal response to abbreviated relaxation techniques. A randomized controlled study. Fink, NS., Urech, C., Isabel, F., et al.[2011]

Maternal emotional health during pregnancy, including depression and anxiety, significantly impacts child development, contributing to 10-15% of emotional and behavioral issues in children.

The Nurse Family Partnership is the only proven intervention that begins during pregnancy and offers long-term benefits for child behavior, highlighting the need for better detection and treatment of maternal mental health issues in obstetric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal depression, anxiety and stress during pregnancy and child outcome; what needs to be done. Glover, V.[2022]

A study involving 60 pregnant women in their second trimester showed that a 6-week relaxation program significantly reduced perceived stress and increased their sense of control over their situation.

The relaxation techniques, including breathing exercises and progressive muscle relaxation, provide a promising non-drug intervention to improve mental well-being during pregnancy, although further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of a stress management programme during pregnancy. Tragea, C., Chrousos, GP., Alexopoulos, EC., et al.[2022]

This systematic review aimed to evaluate the effectiveness of non-medical interventions, like counseling, to reduce stress in pregnant women with a history of miscarriage, but ultimately found no randomized controlled trials (RCTs) that met the inclusion criteria.

While previous studies suggest that support and psychological interventions may benefit the mental health of pregnant women after miscarriage, the lack of suitable RCTs highlights a significant gap in research, indicating a need for targeted studies to identify effective strategies for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological and support interventions to reduce levels of stress, anxiety or depression on women's subsequent pregnancy with a history of miscarriage: an empty systematic review. San Lazaro Campillo, I., Meaney, S., McNamara, K., et al.[2022]

Nearly 90% of pregnant women in the U.S. take medications, but there is a significant lack of comprehensive safety data regarding these medications, which complicates informed discussions between healthcare providers and patients.

Current resources, like package inserts, often rely on incomplete data and animal studies, highlighting the need for better access to up-to-date information and the importance of pregnancy registries to gather more safety data on medication use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Safety During Pregnancy: Improving Evidence-Based Practice. Sinclair, SM., Miller, RK., Chambers, C., et al.[2022]

Medication use during pregnancy is common, but there is limited safety data for most medications, making observational studies crucial for understanding their risks and benefits.

The article emphasizes the importance of using diverse data sources, such as pregnancy registries and electronic health records, to improve the quality of evidence on medication safety in pregnancy and suggests strategies for enhancing study designs to better communicate risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Expectations: Current State and Future Directions for Medication Safety in Pregnancy Research. Wood, ME., Andrade, SE., Toh, S.[2023]

Even low levels of alcohol exposure during pregnancy can harm fetal development, highlighting the need to identify pregnant women who consume alcohol.

Researchers have created effective and simple screening tools that can quickly assess alcohol use in pregnant women, making them valuable preventive measures when used with proper follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol-screening instruments for pregnant women. Chang, G.[2023]

A comprehensive analysis identified 80 prescription medications of greatest concern during pregnancy, primarily including antineoplastic agents, ACE inhibitors, angiotensin II receptor antagonists, and anticonvulsants, based on data from 1,186 medications.

The study utilized advanced prediction models to categorize medications as 'high' risk, providing healthcare providers with an evidence-based tool to better counsel pregnant women on medication safety and the importance of weighing risks and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Supervised Learning Methods to Develop a List of Prescription Medications of Greatest Concern during Pregnancy. Ailes, EC., Zimmerman, J., Lind, JN., et al.[2021]

In a study involving 25 bereaved mothers, most reported that consenting to an autopsy for their stillborn baby provided them with peace of mind and helped reduce feelings of blame.

The results of the autopsy were generally seen as beneficial for coping with the loss, although some participants who struggled to understand the results had negative reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bereaved mothers' attitudes regarding autopsy of their stillborn baby. Human, M., Goldstein, RD., Groenewald, CA., et al.[2022]

Mind-body interventions, such as imagery and autogenic training, may help reduce anxiety in pregnant women, with some studies showing positive effects during labor and in the postpartum period.

While there is some evidence supporting the effectiveness of these interventions for managing anxiety during pregnancy, the studies had limitations, including lack of blinding and insufficient randomization details, indicating that more rigorous research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions during pregnancy for preventing or treating women's anxiety. Marc, I., Toureche, N., Ernst, E., et al.[2022]

Recent research highlights the significant impact of prenatal stress and anxiety on maternal, fetal, and neonatal health outcomes, indicating a need for better understanding and management of these stressors during pregnancy.

The review discusses limited but available treatment measures for addressing prenatal stress and anxiety, along with recommendations for policy development and future research directions to improve reproductive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of anxiety, stress, and psychosocial development to reproductive health. Lederman, RP.[2005]

References

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

The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Fetal response to abbreviated relaxation techniques. A randomized controlled study. [2011]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Maternal depression, anxiety and stress during pregnancy and child outcome; what needs to be done. [2022]

4. Scotland pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of a stress management programme during pregnancy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Psychological and support interventions to reduce levels of stress, anxiety or depression on women's subsequent pregnancy with a history of miscarriage: an empty systematic review. [2022]

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

Medication Safety During Pregnancy: Improving Evidence-Based Practice. [2022]

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

Safe Expectations: Current State and Future Directions for Medication Safety in Pregnancy Research. [2023]

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

Alcohol-screening instruments for pregnant women. [2023]

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

Using Supervised Learning Methods to Develop a List of Prescription Medications of Greatest Concern during Pregnancy. [2021]

10. South Africa pubmed.ncbi.nlm.nih.gov

Bereaved mothers' attitudes regarding autopsy of their stillborn baby. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Mind-body interventions during pregnancy for preventing or treating women's anxiety. [2022]

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

Relationship of anxiety, stress, and psychosocial development to reproductive health. [2005]