Clinical trial Recruiting at 3 sites Interventional Ages 18 to 99

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 typeInterventional
Ages18 Years to 99 Years
SexAll
Enrollment460 (estimated)
SponsorBoston Children's Hospital
Academic / other
Locations3 sites (Boston, Massachusetts and 2 other locations)
StatusRecruiting
StartedSeptember 17, 2019
Main results expectedAugust 1, 2026
Study endsFebruary 28, 2027
Registry record updatedDecember 16, 2025
Trial IDNCT03819933 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.