Advance Fetal Medicine Research with Paperform

Congenital diaphragmatic hernia (CDH) is a serious birth defect that affects approximately 1 in 2,500 births, where an opening in the diaphragm allows abdominal organs to move into the chest cavity and potentially interfere with lung development. For severe cases diagnosed prenatally, fetal intervention offers hope—but enrolling families in these complex research studies requires careful, compassionate data collection and informed consent.

This Congenital Diaphragmatic Hernia Fetal Intervention Research Study template is designed specifically for maternal-fetal medicine centers, pediatric surgery research teams, and academic medical institutions conducting clinical trials involving in-utero interventions for CDH.

What This Template Includes

This comprehensive research enrollment form guides expectant parents through every stage of the study participation process:

• Prenatal diagnosis confirmation including gestational age, imaging findings, liver position, and observed-to-expected lung-to-head ratio (O/E LHR)
• Maternal and fetal medical history to assess eligibility and risk factors
• Detailed informed consent sections covering the experimental nature of fetal intervention, procedural risks, maternal complications, and alternative treatment options
• In-utero surgery procedure explanation with risk acknowledgment checkboxes
• Neonatal outcome prediction factors and long-term follow-up commitment
• HIPAA authorization and research data use consent
• Emergency contact information and obstetrician coordination details

Why Healthcare Researchers Choose Paperform

Paperform isn't HIPAA compliant, so this template is designed for research study enrollment and initial screening rather than protected health information (PHI). For institutions with HIPAA requirements, this form can serve as a first-contact tool before transitioning participants to your secure research database or EHR system.

That said, Paperform brings powerful advantages to clinical research enrollment:

Conditional logic for complex eligibility screening: The form automatically shows or hides questions based on gestational age, CDH severity classification, and maternal health factors—ensuring you only collect relevant data and don't overwhelm already-stressed families with unnecessary questions.

Professional, compassionate design: Healthcare research forms need to balance medical precision with human empathy. Paperform's doc-style editor lets you craft clear explanations, embed educational diagrams or ultrasound images, and create a patient-facing experience that builds trust during an incredibly difficult time.

Seamless integration with research workflows: Connect submissions directly to your research database via Stepper workflows (stepper.io), send enrollment notifications to your fetal surgery coordinator, auto-populate consent documents with Papersign (papersign.com) for electronic signature collection, and keep your REDCap or clinical trial management system in sync.

Multi-page forms with progress tracking: Break complex research enrollment into logical sections—initial screening, medical history, informed consent, risk acknowledgment—so families can complete the form at their own pace without feeling overwhelmed by a wall of medical terminology.

Built for Maternal-Fetal Medicine and Pediatric Surgery Research

This template is tailored for:

• Maternal-Fetal Medicine Centers offering experimental fetal surgery programs
• Pediatric Surgery Departments conducting CDH intervention trials
• Academic Medical Centers with fetal therapy research programs
• Clinical Research Coordinators managing complex prenatal intervention studies
• Perinatal Research Networks coordinating multi-site clinical trials

The medical terminology, risk factors, and outcome measures are specific to CDH fetal intervention research, but the structure can be adapted for other prenatal diagnosis and fetal therapy studies including twin-to-twin transfusion syndrome (TTTS), spina bifida repair, or congenital heart defect interventions.

Automate Your Research Enrollment Workflow

Once a family submits this enrollment form, Stepper can automatically:

• Route the application to your fetal surgery team for eligibility review
• Send a personalized acknowledgment email to the family with next steps
• Create a new participant record in your research database
• Schedule a follow-up consultation with the maternal-fetal medicine specialist
• Generate consent documents pre-populated with the family's information for review
• Notify your IRB coordinator of new enrollment for protocol tracking

This automation means research coordinators spend less time on data entry and more time providing the personalized support that families facing a CDH diagnosis desperately need.

Customizable for Your Institution's IRB Protocol

Every research institution has unique IRB requirements, consent language, and study protocols. This template provides the medical foundation, but Paperform's flexible editor makes it simple to:

• Add your institution's specific consent language and disclosures
• Include risk percentages and outcome data from your center's experience
• Embed videos of your fetal surgery team explaining the procedure
• Adjust eligibility criteria based on your study's inclusion/exclusion parameters
• Collect additional research-specific data points required by your protocol

Trusted by Healthcare Research Teams Worldwide

While this template is tailored for fetal intervention research, the underlying principles—compassionate design, intelligent conditional logic, and workflow automation—make Paperform a powerful tool for clinical research enrollment across specialties. Over 500,000 teams worldwide trust Paperform's SOC 2 Type II compliant platform for forms that matter.

Whether you're advancing the science of fetal medicine, improving outcomes for babies with complex congenital anomalies, or giving families access to potentially life-saving interventions, Paperform gives you the tools to collect accurate data with the care and professionalism these families deserve.

Ready to streamline your fetal intervention research enrollment? Start with this template and customize it to match your institution's specific study protocol and IRB requirements.