Clinical trial NCT04933812: EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan
Official title: EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention Arm
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session
timeFrame: up to 12 weeks after delivery (approximately 1 year)
measure: Number of Sessions Attended by Each Participant
timeFrame: up to 12 weeks after delivery (approximately 1 year)
measure: Implementation as Measured by the Number of Sessions Including Each Topic
timeFrame: up to 12 weeks after delivery (approximately 1 year)
measure: Engagement as Measured by Number of Participants Who Attended More Than One Session
timeFrame: up to 12 weeks after delivery (approximately 1 year)
measure: 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
timeFrame: up to 12 weeks after delivery (approximately 1 year)
Secondary outcomes:
measure: IP3 Knowledge Questionnaire
timeFrame: at intake
measure: Pregnancy-specific Anxiety (PSA)
timeFrame: At intake and at gestational age 20-28 weeks
measure: Interpersonal Processes of Care (IPC)
timeFrame: at intake
measure: Interpersonal Processes of Care (IPC)
timeFrame: Gestational age 20-28 weeks
measure: Interpersonal Processes of Care (IPC)
timeFrame: Gestational age >= 30 weeks
measure: Maternal Social Support Scale (MSSS)
timeFrame: At intake, gestational age 20-28 weeks, and gestational age >=30 weeks
measure: Number of Participants Who Were Adherent to the IP3 Plan
timeFrame: Post delivery (up to approximately 40 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarahn Wheeler, MD
role: PRINCIPAL_INVESTIGATOR
References: