N/A
Completed N=30
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
Source: ClinicalTrials.gov NCT04149002 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Feasibility as Measured by Number of Recruited Eligible Patients Enrolled — 30 Participants
Summary
The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to other racial and ethnic groups. Building on qualitative data from NHB women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an IP3 in NHB women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Measured by Number of Recruited Eligible Patients Enrolled |
30 | — |
| PRIMARY Acceptability as Measured by Number of Participants Who Completed the Study |
12; 16 | — |
| SECONDARY IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance |
1; 3 | — |
| SECONDARY Pregnancy Specific Anxiety (PSA) |
2.6; 2.4; 2.3; 2.3 | — |
| SECONDARY Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain |
1.6; 1.6; 4.6; 4.7; 4.5; 4.6 | — |
| SECONDARY Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain |
4.4; 4.8 | — |
| SECONDARY Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain |
4.7; 4.8; 1.5; 1.3; 1.2; 1.1 | — |
| SECONDARY Change in Maternal Social Support Scale (MSSS) |
0.1; -1.4 | — |
| SECONDARY Gestational Age at Delivery in Weeks |
34.0; 35.7 | — |
| SECONDARY Birth Weight in Grams |
2442.5; 2607.9 | — |
| SECONDARY Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) |
5; 4 | — |
| SECONDARY Length of Delivery Hospital Admission in Days |
2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- self described race as Non-Hispanic Black
- history of prior singleton preterm delivery (before 37 weeks gestation)
- current singleton gestation
Exclusion Criteria
- women with anomalous fetuses
- age below 18]
- non-English speaking
Data sourced from ClinicalTrials.gov (NCT04149002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.