EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Behavioral: Facebook discussions and Virtual group meetings

• Registration Number: NCT04933812
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Non-Hispanic black (NHB) women are 49% more likely to experience a preterm birth (PTB), delivery before 37 weeks. PTB is associated with increased risk of poor short and long-term neonatal outcomes. PTB can occur in multiple clinical scenarios including spontaneous PTB (e.g. preterm labor, preterm pre-labor rupture of membranes) and medically induced preterm labor (e.g. preeclampsia). Women with a history of PTB are at 1.5 - 2 fold increased risk for future PTB. There are medical therapies than can reduce the risk of recurrent PTB specific to the presumed etiology of the prior PTB. Thus, women with a history of a prior PTB who receive care with Duke Maternal Fetal Medicine (MFM) receive and Individualized Prematurity Prevention Plan (IP3) to reduce their risk of recurrent PTB. The IP3 plans are often labor intensive with requirements ranging from daily medications, weekly clinic visits, painful injections or invasive ultrasounds.

Given the increased rate so of PTB among NHB women and some suggestion of decreased adherence in this population1, we previously conducted qualitative studies with NHB women to uncover patient perceived barriers to IP3 adherence2,3. These studies revealed that NHB women with prior preterm birth felt that stress and lack of support were key barriers to preterm birth prevention adherence. Stress and limited support made women feel isolated from their peers and community. Based on these data we worked with a stakeholder group to develop a patient-centered, community-involved intervention that will increased adherence to an individualized prematurity prevention plan using community-level social supports. The resulting invention titled, EngagINg the COmmunity to Reduce Preterm Birth via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3) includes community doula led group social support.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study Start: 2021-06-21
• Study First Posted: 2021-06-22
• Primary Completion: 2022-10-14
• Study Completion: 2022-10-14
• Results First Submitted: 2023-10-05
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Results First Posted: 2024-11-04
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

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Exclusion Criteria

• women with anomalous fetuses
• age below 18 years
• non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group Social Support Meetings and Facebook Group	Facebook discussions and Virtual group meetings	Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.

Primary Outcome Measures

Name	Time	Method
Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session	up to 12 weeks after delivery (approximately 1 year)
Implementation as Measured by the Number of Sessions Including Each Topic	up to 12 weeks after delivery (approximately 1 year)
Number of Sessions Attended by Each Participant	up to 12 weeks after delivery (approximately 1 year)	As a measure of effectiveness
Engagement as Measured by Number of Participants Who Attended More Than One Session	up to 12 weeks after delivery (approximately 1 year)	Intervention sustainability based on continued engagement from the participants
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	up to 12 weeks after delivery (approximately 1 year)	Intervention sustainability based on continued engagement from the participants

Secondary Outcome Measures

Name	Time	Method
IP3 Knowledge Questionnaire	at intake	Questionnaire includes approximately four questions aimed to evaluate a participants knowledge about the details of their IP3 plan. Participants will only receive questions that pertain to their specific IP3. They will be given the answers immediately following the assessment. Understanding of preterm birth and precautions; higher scores better, each questionnaire ranges from 0 to 5 questions correct
Pregnancy-specific Anxiety (PSA)	At intake and at gestational age 20-28 weeks	The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. On a Likert scale of 1 to 5, higher scores indicate greater anxiety.
Interpersonal Processes of Care (IPC)	Gestational age >= 30 weeks	The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.
Maternal Social Support Scale (MSSS)	At intake, gestational age 20-28 weeks, and gestational age >=30 weeks	The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. On a Likert scale of 1 to 5, higher scores indicate greater social support.
Number of Participants Who Were Adherent to the IP3 Plan	Post delivery (up to approximately 40 weeks)	Adherence to the IP3 based on both participant report and EHR chart review; dichotomized as adherent or not adherent.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States