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Mastery Lifestyle Intervention for Premature Birth (MLI Trial)

Phase 2

Recruiting

Led By Roberta J Ruiz, PhD

Research Sponsored by Microgen LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 45 years

Ability to read and speak English or Spanish

Must not have

Major systemic infections such as HIV, hepatitis

<18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test an intervention to see if it can help reduce the risk of preterm birth in pregnant Hispanic women.

Who is the study for?

This trial is for pregnant women aged 18-45, of Mexican heritage or African American, with government insurance. They must be at 14-20 weeks gestation with one fetus and show signs of stress or anxiety. Excluded are those under 18, in certain prenatal programs, with severe cognitive issues, unable to read English/Spanish, or have major infections like HIV.

What is being tested?

The Mastery Lifestyle Intervention (MLI) aims to reduce preterm birth risks through a psychoeducational program over six sessions compared to standard care. The study will measure hormone levels and infant outcomes at delivery among the participants.

What are the potential side effects?

Since MLI is a psychoeducational intervention rather than a drug treatment, side effects may include emotional discomfort due to discussions about personal experiences related to pregnancy but no physical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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I can read and speak English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major infections like HIV or hepatitis.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Coping levels

Depression

+1 more

Secondary study objectives

To explore the effect of the MLI, versus a usual care group, on neuroendocrine risk factors (progesterone) on preterm birth from baseline to end-of treatment.

To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.

To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of preterm birth (Corticotropin Releasing Hormone (CRH).from baseline to end-of treatment.

Other study objectives

To explore the effect of the MLI on infant birthweight

To explore the effect of the MLI on infant gestational age at birth

To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit