Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT03819933

Conditions

Preterm Pregnancy

Premature Birth

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Educational intervention

Study Details

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 goal of this project is to improve antenatal counseling and counseling outcomes for families facing anticipated extremely preterm delivery through innovative, interdisciplinary simulation-based education for maternal fetal medicine specialists and neonatologists, using language preferred by families, and focusing on eliciting values and building partnerships through advanced communication and relational skills.

Conditions

Preterm Pregnancy

Premature Birth

Study ID

NCT03819933

Start date

Sep 17, 2019

Status verified date

Dec, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

460 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Pregnant women and their partners

For the qualitative arm of this mixed method study, using an exploratory sequential design, investigators will enroll \~ 30 adult pregnant women admitted estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners to participate in a post-counseling semi-structured interview to explore preferred language and approaches, and better inform questionnaire development. Sample size will be up to 30 families, or until thematic saturation is achieved (total up to 60 if all partners agree to participate).

For the quantitative arm of this study, investigators will enroll \~100 adult pregnant women admitted between estimated 22 0/7-25 6/7 weeks' estimated gestation and their partners (up to total \~200 if all partners present and agree to participate).

other: Counseling MFM and Neonatology providers

Investigators will enroll \~100 counseling Maternal-Fetal Medicine (MFM) specialists and 100 counseling Neonatologists (total \~200 providers), who provided counseling to the enrolled pregnant women between 22 0/7-25 6/7 weeks' estimated gestation for anticipated extremely preterm delivery. This assumes 1 counseling provider from MFM and 1 from Neonatology per pregnant woman, although there could be more if a consult is performed by both an attending physician and a training fellow or practitioner, or less, if a counseling provider declines to participate in the study. There will be anticipated repetition of counseling providers, accounted for in the statistical analysis. Providers will be asked to complete educational interventions to improve counseling at extreme prematurity.

Interventions

Educational intervention

Investigators will first determine preferred language and approaches by families, then redefine current training for prenatal counseling at extreme prematurity by developing and implementing two novel, interdisciplinary simulation-based educational programs for MFM and Neonatology (a workshop and an online module), focusing on eliciting values and building partnerships through advanced communication and relational skills, to improve counseling practices and outcomes

Primary outcome measure

  • Parental knowledge [ Time Frame: 5 years ]
  • Parental satisfaction: The Parental Questionnaire [ Time Frame: 5 years ]
  • Parental decision making [ Time Frame: 5 years ]
  • Parental anxiety [ Time Frame: 5 years ]
  • Parental preferred language and terminology [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Christy L Cummings, MD

617-355-2539christy.cummings@childrens.harvard.edu

Vanessa J Young, RN, BA

617-355-8330vanessa.young@childrens.harvard.edu

Locations

Boston Children's Hosptial

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Christy Cummings, MD

6173552539Christy.Cummings@childrens.harvard.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

John Zupancic, MD

6176673276jzupanci@bidmc.harvard.edu

South Shore Hospital

Recruiting

Weymouth, Massachusetts, United States, 02190

Contacts

Bonnie Arzuaga, MD

6173554647Bonnie.Arzuaga@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Counseling
  • Extreme Prematurity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-12-16.