Condition: Mental Health Wellness 1 · Preterm Birth · Sponsor: Microgen LLC
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.
This description comes directly from the study's public registry record.
Roberta J. Ruiz, PhD · 2813005265 · raruiz20@central.uh.edu
Kathryn Tart, EdD, MSN, RN · kmtart@Central.UH.EDU
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| Women's Specialist of PLLC | Webster, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05012072