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NCT04158089 · ClinicalTrials.gov registry record · NA
Holistic Assessment of Tulsa Children's Health
A NA study of Pregnancy, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
- 1
- Study location
NCT04158089 is a NA study of Pregnancy that has completed, run by University of Oklahoma. The registered enrollment target is 129 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04158089, a NA study of Pregnancy, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary goal of this study is to rapidly increase maternal-fetal bonding, a strong predictor of maternal health practices during pregnancy, through an intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy using a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 women (ages 18 or older) who are 12-16 weeks pregnant. Participants will be randomly assigned into one of two groups for the intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment/mindfulness exercises. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. Pre- and post-tests will be used to assess maternal-fetal bonding and smoking before and after the intervention to allow for examination of change across pregnancy. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)
Study Locations (1)
Oklahoma
- OU Women's Health and Specialty Clinic - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2023-07-18 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04158089
The ClinicalTrials.gov registry entry for NCT04158089 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (85% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Babies and Moms connected through Love, Openness, and Opportunity (BLOOM) is the first listed.
NCT04158089 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT04158089 about?
NCT04158089 is a clinical study titled "Holistic Assessment of Tulsa Children's Health". The primary goal of this study is to rapidly increase maternal-fetal bonding, a strong predictor of maternal health practices during pregnancy, through an intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in mater...
What is the current status of trial NCT04158089?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2021-12-20. Estimated completion is 2023-07-18.
What conditions does trial NCT04158089 study?
This clinical trial studies the following conditions: Pregnancy.
What interventions are being tested in trial NCT04158089?
The interventions under investigation include: Babies and Moms connected through Love, Openness, and Opportunity (BLOOM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04158089?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04158089 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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