Status:
RECRUITING
Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Preterm Pregnancy
Premature Birth
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Antenatal family counseling for anticipated extremely preterm deliveries remains ethically and practically challenging for maternal-fetal medicine specialists and neonatologists alike. The overall goa...
Detailed Description
Extremely preterm birth near the limit of viability, defined broadly as birth between 20 and 26 weeks' gestation, accounts for substantial infant morbidity and mortality as well as both parental and p...
Eligibility Criteria
Inclusion
- Pregnant women and their partners
- 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
- Non-English proficient
- Fetal congenital malformation(s)
- \<18y old
- \<22 0/7 or \> 25 6/7 weeks' estimated gestation
- Repeat consultation
- 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)
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT03819933
Start Date
September 17 2019
End Date
February 28 2027
Last Update
December 16 2025
Active Locations (3)
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1
Boston Children's Hosptial
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
South Shore Hospital
Weymouth, Massachusetts, United States, 02190