N/A
Completed N=31
EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan
Source: ClinicalTrials.gov NCT04933812 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Nov 2024
Primary outcomePrimary: Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session — 20 Participants
Summary
The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger trial focused on determining efficacy. Feasibility will be measured using the RE-AIM framework4: Reach or Participation (Primary Outcome): (a) percent of eligible participants who are successfully recruited and attend at least one group session; Effectiveness: retention rate in the intervention; Implementation: fidelity to the intervention protocol; Maintenance: intervention sustainability based on continued engagement from the participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session |
20 | — |
| PRIMARY Number of Sessions Attended by Each Participant |
5.7 | — |
| PRIMARY Implementation as Measured by the Number of Sessions Including Each Topic |
14; 31; 14; 7; 13; 5 | — |
| PRIMARY Engagement as Measured by Number of Participants Who Attended More Than One Session |
17 | — |
| PRIMARY Engagement as Measured by Number of Participants Who Completed PSA (Pregnancy-specific Anxiety), IPC-18 (Interpersonal Processes of Care), MSSS (Maternal Social Support Scale), and CSQ-9 (Client Satisfaction Questionnaire) at All Time Points |
22 | — |
| SECONDARY IP3 Knowledge Questionnaire |
2.6; 2.3; 3.0; 3.1 | — |
| SECONDARY Pregnancy-specific Anxiety (PSA) |
2.7; 2.2 | — |
| SECONDARY Interpersonal Processes of Care (IPC) |
1.8; 4.5; 4.6; 4.5; 4.6; 1.4 | — |
| SECONDARY Maternal Social Support Scale (MSSS) |
27.3; 28.2; 27.7 | — |
| SECONDARY Number of Participants Who Were Adherent to the IP3 Plan |
8; 2; 6; 0; 7; 6 | — |
Eligibility Criteria
Inclusion Criteria
- self describe race as Non-hispanic black
- history of prior singleton preterm delivery (before 37 weeks gestation
- current singleton gestation, with Individualized Prematurity Prevention (IP3) plan.
Exclusion Criteria
- women with anomalous fetuses
- age below 18 years
- non-English speaking
Data sourced from ClinicalTrials.gov (NCT04933812). 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.