Improving family counseling for extremely preterm deliveries
Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
This study is trying to improve how doctors talk to families about extremely preterm deliveries to make sure they feel understood and supported during a tough time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT03819933 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance antenatal counseling for families facing extremely preterm deliveries through innovative, interdisciplinary simulation-based education for maternal-fetal medicine specialists and neonatologists. The focus is on using language preferred by families and developing advanced communication skills to build trust and elicit family values. By addressing the challenges in prenatal counseling, the study seeks to improve understanding, shared decision-making, and overall satisfaction for families during this critical time.
Who should consider this trial
Good fit: Ideal candidates include English-proficient pregnant women between 22 to 25 weeks' gestation anticipating extremely preterm delivery, along with their partners.
Not a fit: Patients who are non-English proficient, under 18 years old, or have fetal congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better-informed families and improved outcomes for infants born extremely preterm.
How similar studies have performed: While there is a need for improved counseling approaches, this specific interdisciplinary simulation-based education method is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
1. Pregnant women and their partners Inclusion Criteria: * English-proficient adult pregnant woman admitted between 22 0/7-25 6/7 weeks' estimated gestation for anticipated extremely preterm delivery and her adult partner (if available) for whom an antenatal neonatal intensive care unit (NICU) consultation was requested and performed Exclusion Criteria: * Non-English proficient * Fetal congenital malformation(s) * \<18y old * \<22 0/7 or \> 25 6/7 weeks' estimated gestation * Repeat consultation 2. Counseling MFM and Neonatology providers Inclusion Criteria: * Practicing MFM or Neonatology provider (attending, fellow, resident, practitioner or RN) from the 3 participating sites: Brigham \& Women's Hospital (BWH), Beth Israel Deaconess Medical Center (BIDMC), South Shore Hospital (SSH) Exclusion Criteria: * None
Where this trial is running
Boston, Massachusetts and 2 other locations
- Boston Children's Hosptial — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- South Shore Hospital — Weymouth, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christy Cummings — Boston Children's Hospital
- Study coordinator: Christy L Cummings, MD
- Email: christy.cummings@childrens.harvard.edu
- Phone: 617-355-2539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.