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Completed

NCT Number: NCT04933812

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facebook discussions and Virtual group meetings

Behavioral

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

Primary outcomes

  1. Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session

    Time frame: up to 12 weeks after delivery (approximately 1 year)

  2. Number of Sessions Attended by Each Participant

    Time frame: up to 12 weeks after delivery (approximately 1 year)

    As a measure of effectiveness

  3. Implementation as Measured by the Number of Sessions Including Each Topic

    Time frame: up to 12 weeks after delivery (approximately 1 year)

  4. Engagement as Measured by Number of Participants Who Attended More Than One Session

    Time frame: up to 12 weeks after delivery (approximately 1 year)

    Intervention sustainability based on continued engagement from the participants

  5. 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

    Time frame: up to 12 weeks after delivery (approximately 1 year)

    Intervention sustainability based on continued engagement from the participants

Secondary outcomes

  1. IP3 Knowledge Questionnaire

    Time frame: 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

  2. Pregnancy-specific Anxiety (PSA)

    Time frame: 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.

  3. Interpersonal Processes of Care (IPC)

    Time frame: at intake

    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.

  4. Interpersonal Processes of Care (IPC)

    Time frame: Gestational age 20-28 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.

  5. Interpersonal Processes of Care (IPC)

    Time frame: 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.

  6. Maternal Social Support Scale (MSSS)

    Time frame: 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.

  7. Number of Participants Who Were Adherent to the IP3 Plan

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2021
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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