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

Preterm Birth Clinical Trial

Official title:

EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933812
• Other study ID #: Pro00107668
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: October 14, 2022

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Facebook discussions and Virtual group meetings
Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach or Participation Rate	Percent of eligible participants who are successfully recruited and attend at least one group session	1 year
Primary	Effectiveness	Retention rate in the intervention measured by the number of sessions each participant	1 year
Primary	Implementation	Fidelity to the intervention protocol by observer at each group session recording the topics	1 year
Primary	Maintenance	Intervention sustainability based on continued engagement from the participants	1 year
Secondary	IP3 knowledge questionnaire	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	monthly until delivery
Secondary	Pregnancy-specific anxiety (PSA)	The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. higher scores are negative, four questions answered on a 1 to 5 Likert scare	monthly until delivery
Secondary	Interpersonal Processes of Care (IPC)	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). All domains are measured 1 to 5 on a Likert scale	monthly until delivery
Secondary	Maternal Social Support Scale (MSSS)	The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. Higher scores better - 1 to 5 Likert scale	monthly until delivery
Secondary	IP3 Adherence Data	We will gather data on adherence to the IP3 based on both participant report and EHR chart review. Higher is better, dichotomized as adherent or not adherent	monthly until delivery
Secondary	Tobacco Use PRAMS Questionnaire	A single question regarding tobacco use	monthly until delivery