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NCT05012072 · ClinicalTrials.gov registry record · NA
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
A NA study of Preterm Birth and Mental Health Wellness 1, sponsored by Microgen.
- Recruiting
- Registry status
- NA
- Development phase
- 238
- Enrollment target
- 1
- Study location
NCT05012072 is a NA study of Preterm Birth and Mental Health Wellness 1 that is actively recruiting participants, run by Microgen. The registered enrollment target is 238 participants, below the 4,623-participant average among 37 other Preterm Birth trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05012072, a NA study of Preterm Birth and Mental Health Wellness 1, is actively recruiting participants, sponsored by Microgen.
- RECRUITING
- Registry status
- NA
- Development phase
- 238 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL The Mastery Lifestyle Intervention
Study Locations (1)
Texas
- Women's Specialist of PLLC - Webster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2026-04-13 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05012072
The ClinicalTrials.gov registry entry for NCT05012072 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,623-participant average among 37 other Preterm Birth trials with a reported enrollment target (95% lower). The listed sponsor is Microgen, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which The Mastery Lifestyle Intervention is the first listed.
NCT05012072 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05012072 about?
NCT05012072 is a clinical study titled "Reducing Pregnancy Risks: The Mastery Lifestyle Intervention". 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 gro...
What is the current status of trial NCT05012072?
This trial is currently recruiting. It is a NA study. The enrollment target is 238 participants. The study started on 2021-08-01. Estimated completion is 2026-04-13.
What conditions does trial NCT05012072 study?
This clinical trial studies the following conditions: Preterm Birth, Mental Health Wellness 1.
What interventions are being tested in trial NCT05012072?
The interventions under investigation include: The Mastery Lifestyle Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05012072?
This trial is sponsored by Microgen, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05012072 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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