Related Experiment Video
Updated: Aug 14, 2025
A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High
Sarahn M Wheeler1, Kelley E C Massengale2, Thelma A Fitzgerald1
1Division of Maternal and Fetal Medicine, Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, North Carolina, USA.
Insights
This study found a new intervention to be feasible and acceptable for improving preterm birth prevention adherence in non-Hispanic black birthing individuals. Further research is needed to confirm its effectiveness in reducing preterm birth rates.
Area of Science:
- Obstetrics and Gynecology
- Public Health
- Maternal-Fetal Medicine
Background:
- Preterm birth is a leading cause of neonatal morbidity and mortality.
- Non-Hispanic black individuals experience disproportionately higher rates of preterm birth and lower adherence to preventive measures.
- There is an urgent need for interventions tailored to non-Hispanic black birthing individuals (NHBBIs) to address barriers to preterm birth prevention.
Purpose of the Study:
- To develop and pilot a community-engaged intervention to improve adherence to preterm birth prevention strategies among black pregnant patients with a history of preterm birth.
- To assess the feasibility and acceptability of the intervention.
- To explore preliminary efficacy related to birth outcomes, patient experience, and pregnancy-specific anxiety (PSA).
Main Methods:
- A multidisciplinary stakeholder group co-developed an intervention including education, an employment navigation toolkit, and text message encouragement.
- A pilot study randomized self-identified non-Hispanic black patients with prior preterm birth (≤20 weeks gestation) to the intervention or an active control.
- Feasibility, acceptability, adherence, birth outcomes, patient experience, and PSA were assessed using descriptive statistics and qualitative analysis.
Main Results:
- The study successfully enrolled and retained over 80% of participants (n=30).
- All participants found at least one intervention component helpful, indicating high acceptability.
- No significant differences in adherence to preventive recommendations, preterm birth rates, or other outcomes were detected between the intervention and control groups in this small pilot.
Conclusions:
- The developed intervention is feasible and acceptable for NHBBIs with a history of preterm birth.
- Larger, adequately powered studies are required to determine the intervention's efficacy in reducing preterm birth and pregnancy-specific anxiety.
- This pilot study provides a foundation for future research and intervention refinement.
Introduction:
Preterm birth is a major cause of neonatal morbidity and mortality rate. Non-Hispanic black patients disproportionately experience preterm birth and nonadherence to evidence-based preventive measures. Interventions tailored to non-Hispanic black birthing individuals (NHBBIs) that address barriers to preterm birth preventions are urgently needed.
Methods:
Together with a community-engaged multidisciplinary stakeholder group, we developed an intervention to improve adherence to preterm birth preventions among black pregnant patients with prior preterm birth. The intervention included the following: (1) preterm birth prevention education, (2) an employment navigation toolkit, and (3) encouragement text messages. We piloted the intervention by recruiting self-identified non-Hispanic black patients at or before 20 weeks of gestation with a prior preterm birth and randomizing them to the intervention or an active control. The primary outcomes were feasibility and acceptability. Our secondary outcomes were preliminary efficacy based on birth outcomes, patient experience, and pregnancy-specific anxiety (PSA). Descriptive statistics, analysis of verbatim survey responses, Wilcoxon signed rank, and Fisher's exact were used to describe and compare quantitative and qualitative data.
Results:
We identified 53 individuals who met the inclusion criteria, 35 were reachable remotely and 30 were enrolled and randomized. More than 80% (n=26) were retained throughout the study, and 100% of participants identified at least one intervention component as helpful. In this small pilot, there were no detectable differences in adherence to preterm birth preventive recommendations. No difference in preterm births, other pregnancy, or patient experience outcomes was detected between the intervention and active control participants.
Discussion:
The intervention is feasible and acceptable. Larger, appropriately powered studies are needed to assess whether the intervention will decrease PSA and reduce preterm birth. This trial was registered with ClinicalTrials.gov (NCT04933812).
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