Improving family counseling for extremely preterm deliveries
Official title: Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
Run by Boston Children's Hospital · NCT03819933 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 460 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Status | Recruiting |
| Started | September 17, 2019 |
| Main results expected | August 1, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT03819933 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include English-proficient pregnant women between 22 to 25 weeks' gestation anticipating extremely preterm delivery, along with their partners.
✕Probably not a fit
Patients who are non-English proficient, under 18 years old, or have fetal congenital malformations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.