Treatment for Prenatal Stress

Phase-Based Estimates
1
Effectiveness
1
Safety
Saint Joseph Hospital, Denver, CO
+1 More
Eligibility
18 - 65
Female
Eligible conditions
Prenatal Stress

Study Summary

This study is evaluating whether a nutritional supplement may help improve early brain development.

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Eligible Conditions

  • Prenatal Stress
  • Development, Child

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Prenatal Stress. Measurement will happen over the course of 4 Years of age.

4 Years of age
Behavior rated on the Child Behavior Checklist.

Trial Safety

Trial Design

2 Treatment Groups

Participants will take placebo
Placebo group

This trial requires 600 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Participants will take placebo
DietarySupplement
Participants will take placebo. Corn oil every day in place of choline
Drug: Choline
Drug
Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years of age
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years of age for reporting.

Closest Location

Saint Joseph Hospital - Denver, CO

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
ages 18-45 years
prepregnancy BMI>18 and <45

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can prenatal stress be cured?

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[Prenatal maternal stress in a rodent model that resembles human pregnancy] may affect the function of the neonatal brain. Given the limited data regarding the effects of maternal prenatal stress on subsequent neonatal development of rodent model systems, future investigations in other species will be of high utility to further our understanding of these effects.

Unverified Answer

How many people get prenatal stress a year in the United States?

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Recent findings, only a mere 2.7% of US adults reported receiving prenatal stress during pregnancy. However, when taking into account the actual number of stress episodes experienced during a person's lifetime, up to 20% of US adults could be considered to have had some level of prenatal stress in their lives. These percentages may be underestimated, given the paucity of prenatal stress research and the subjective nature of the stress response. Future research assessing the association between prenatal stress exposure and pregnancy outcomes should make more effort in collecting more precise measurement of prenatal stress, and more stringent controls for potential confounding variables.

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What are common treatments for prenatal stress?

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Prenatal stress is a global phenomenon with different underlying causes, consequences, and treatments within different geographic areas. The challenge to developing a international guideline is the heterogeneity of the underlying causes, consequences, and treatments among and between geographic regions.

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What is prenatal stress?

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Although a significant association of maternal stress with the developing fetus was not found, an adverse effect of stress on developing fetal heart rate was.

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What causes prenatal stress?

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Prenatal stress may be a risk factor for subsequent mood disorders. Prenatal stress and depressive symptoms have strong negative associations in pregnancy and in the puerperium indicating prenatal stress-prenatal depression interactions.

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What are the signs of prenatal stress?

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Maternal stress hormones (sympathetic and hormonal) rise during gestation. These changes affect the fetus and may be harmful to the infant. Stress does not result in detectable changes in prenatal neurobiology and the fetal environment does not change or have long-term consequences in the infant as originally described.\n

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Have there been any new discoveries for treating prenatal stress?

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Few studies assessed PNS in pregnancy, and they did not observe a direct correlation to birth defects. Additional epidemiologic, experimental, and clinical studies are needed to confirm PNS's role.

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What is the average age someone gets prenatal stress?

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This is a contentious issue as [a pregnant woman's health can be damaged due to prenatal stress] and many studies are done proving that pregnancy is better. However, from this study, it can be concluded that [a pregnant woman's health may be deteriorating due to prenatal stress] that it is approximately 1/3 of pregnancy from a woman over 30, and it is nearly equal between a woman in their 30s and 40s. [Note: A pregnant woman whose age is 1/3 over the average of the age of a pregnant woman will have approximately 1/2 of their pregnancies when pregnant at age 24].

Unverified Answer

Does prenatal stress run in families?

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Prenatal stress appears to be associated with increased risk for ADHD and antisocial behavior through effects on the HPA axis and monoamine oxidase activity. A significant association was also demonstrated between postnatal maternal stress and ADHD and antisocial behavior in the toddler group.

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What does treatment usually treat?

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[While most treatments have a defined goal, it is unclear what we can measure in treatments to ensure that different therapies result in similar outcomes. Treatment effectiveness must be measured in more than a few outcomes to provide effective evidence of their efficacy] post-surgical outcomes are very poorly measured in trials examining treatments for most conditions, and outcome data are seldom as easily accessible as in some medical conditions, such as in ALS. In the long-term, some treatments may provide more durable remission for patients with certain conditions. Many trials, even those with high outcomes, may omit one or more aspects of outcomes.

Unverified Answer

What is treatment?

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Women are advised to consult a gynaecologist or midwife about all their worries or worries. They will also be encouraged to attend appointments with their General Practitioner. All these measures help to create a supportive community where women can be monitored and reassured. If there is a significant need for specific counselling, [in addition to being able to speak to a counsellor, women could also contact Power for support.

Unverified Answer

What is the latest research for prenatal stress?

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The majority of the studies that have looked into prenatal stress and subsequent effects were conducted on rodent models. It will likely be impossible to extrapolate directly to humans since they are more susceptible to stress during pregnancy and after birth. However, we can infer that prenatal stress may be a factor in development of chronic diseases such as asthma and type 2 diabetes in adulthood. Research on non-human primates has been conducted extensively, but as a result of ethical concerns, more research is needed on the effects that prenatal stress has in more sensitive species such as humans. In addition, more research is needed to determine the potential long-term effects and potential protective and/or protective factors that occur during pregnancy.

Unverified Answer
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