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Behavioral Intervention

Family Counseling Education for Preterm Birth

N/A
Recruiting
Led By Christy Cummings
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will improve how doctors talk to families about extremely preterm births, using simulations to train them in advanced communication and relational skills.

Who is the study for?
This trial is for English-speaking pregnant women between 22-25 weeks' gestation facing extremely preterm delivery, and their partners. It's also for maternal-fetal medicine (MFM) or neonatology providers at three specific hospitals. Excluded are non-English speakers, those with fetal malformations, under 18 years old, outside the gestational window, or seeking repeat consultations.Check my eligibility
What is being tested?
The study tests an educational intervention aimed to enhance antenatal counseling by healthcare professionals for families expecting a very premature baby. The focus is on using family-preferred language and advanced communication skills to align with the family's values and foster partnership.See study design
What are the potential side effects?
Since this trial involves an educational intervention rather than a medical treatment, traditional physical side effects are not expected. However, participants may experience emotional or psychological responses to discussions about extremely preterm birth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a pregnant woman, speak English, and am expected to deliver extremely preterm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety
Parental decision making
Parental knowledge
+2 more
Secondary outcome measures
Effect of Educational Interventions
Maternal versus Paternal/Partner preferences
Provider anxiety

Side effects data

From 2018 Phase 4 trial • 320 Patients • NCT03068897
4%
Gastrointestinal complaint
3%
Drowsiness
1%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metaxalone
Baclofen
Placebo
Tizanidine

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pregnant women and their partnersExperimental Treatment1 Intervention
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).
Group II: Counseling MFM and Neonatology providersExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Educational intervention
2018
Completed Phase 4
~15170

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterOTHER
837 Previous Clinical Trials
13,009,812 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,615 Previous Clinical Trials
11,470,370 Total Patients Enrolled
South Shore HospitalOTHER
12 Previous Clinical Trials
10,381 Total Patients Enrolled

Media Library

Educational intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03819933 — N/A
Preterm Birth Research Study Groups: Counseling MFM and Neonatology providers, Pregnant women and their partners
Preterm Birth Clinical Trial 2023: Educational intervention Highlights & Side Effects. Trial Name: NCT03819933 — N/A
Educational intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03819933 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots open for enrollment in this research project?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, first announced on September 17th 2019, is currently accepting applications. 460 participants are needed at 3 separate locations to complete the study."

Answered by AI

Are individuals over 35 years of age eligible to participate in this experiment?

"Those desiring to participate in this medical study must be between 18 and 99 years old. There are also seperate studies accommodating those under 18 or over 65; 184 for the former, 75 for the latter."

Answered by AI

May I qualify for involvement in this research endeavor?

"This medical trial is searching for 460 participants who were born prematurely and are between 18-99 years old. Admission into this study requires meeting these criteria."

Answered by AI

What is the current size of this medical study?

"Affirmative. The clinicaltrials.gov website reveals that this trial is still recruiting participants, starting from the 17th of September 2019 and most recently on October 11th 2022. 460 patients must be sourced across 3 locations for enrollment to take place."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
Christy Cummings 2019. "Optimizing Family Counseling for Anticipated Extremely Preterm Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03819933.
~65 spots leftby Feb 2025
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