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

NCT04933812 | Completed Results

• 1 other identifier: Pro00107668
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (5)

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

  up to 12 weeks after delivery (approximately 1 year)

• Number of Sessions Attended by Each Participant

  As a measure of effectiveness

  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)

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

  Intervention sustainability based on continued engagement from the participants

  up to 12 weeks after delivery (approximately 1 year)

• 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

  Intervention sustainability based on continued engagement from the participants

  up to 12 weeks after delivery (approximately 1 year)

Secondary Outcomes (7)

• IP3 Knowledge Questionnaire

  at intake

• Pregnancy-specific Anxiety (PSA)

  At intake and at gestational age 20-28 weeks

• Interpersonal Processes of Care (IPC)

  at intake

• Interpersonal Processes of Care (IPC)

  Gestational age 20-28 weeks

• Interpersonal Processes of Care (IPC)

  Gestational age >= 30 weeks

Study Arms (1)

Group Social Support Meetings and Facebook Group

OTHER

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.

Behavioral: Facebook discussions and Virtual group meetings

Interventions

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

Group Social Support Meetings and Facebook Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Wheeler SM, Massengale KEC, Fitzgerald TA, Truong T, Ostbye T, Corneli A, Swamy GK. IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk. Health Equity. 2022 Dec 19;6(1):922-932. doi: 10.1089/heq.2022.0089. eCollection 2022.

  PMID: 36636112 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Sarahn Wheeler
• Organization: Duke University

sarahn.wheeler@duke.edu

919-668-5462

Study Officials

• Sarahn Wheeler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Arm

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: June 21, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)