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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: Completed NA study of Pregnancy, sponsored by University of Oklahoma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maternal-Fetal Attachment Scale (MFAS) is a 24-item, Likert type, self-rated scale with five subscales (Cranley, 1981)
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 |
What the finished NCT04158089 record still lists
NCT04158089 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04158089's enrollment target sits among peer trials
129 108th of 191 higher than 83 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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