Twins With Specific vs. Traditional Fetal Growth Charts

NCT ID: NCT07164001

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-01-28

Brief Summary

This study aims to compare how well two different types of fetal growth charts work in tracking the growth of twins during pregnancy. These charts help doctors decide if a fetus is growing normally. One type is commonly used for all pregnancies, while the other is specially designed for twin pregnancies. The study will enroll pregnant individuals carrying twins. Participants will be randomly assigned to have their care guided by either the traditional chart or the twin-specific chart. Researchers will compare outcomes such as birth weight, timing of delivery, and newborn health. The goal is to find out if using twin-specific charts can improve care and reduce unnecessary interventions.

Detailed Description

Twin pregnancies are at increased risk for growth abnormalities and adverse perinatal outcomes. Despite physiological differences in fetal growth patterns between singleton and twin pregnancies, most clinical decisions in the United States still rely on singleton-based fetal growth charts. This randomized controlled trial (RCT) evaluates whether using twin-specific fetal growth charts to guide clinical care results in better perinatal outcomes compared to using standard singleton-based charts.

Participants will be pregnant individuals with twin gestations receiving routine prenatal care at participating clinical sites. Eligible participants will be randomized to one of two groups: (1) management based on singleton growth charts or (2) management based on twin-specific charts. Both charts will be used to assess fetal growth during ultrasound visits, but only the chart assigned to the participant's group will inform clinical decision-making. Data will be collected on outcomes including birth weight, small-for-gestational-age (SGA) classification, gestational age at delivery, NICU admissions, and neonatal morbidity.

The study aims to determine whether using twin-specific fetal growth standards can reduce the overdiagnosis of growth restriction and the associated risks of iatrogenic preterm delivery and unnecessary interventions. Results may support more tailored approaches to growth assessment in twin pregnancies.

Conditions

Twin Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Twin-Specific Growth Chart Group

Participants in this arm will receive prenatal ultrasound assessments interpreted using a twin-specific growth chart for estimated fetal weight and biometry. Clinical decisions and perinatal risk assessments will be guided based on twin-specific percentiles.

Group Type: EXPERIMENTAL

Twin-Specific Growth Chart Interpretation

Intervention Type: OTHER

Participants in this arm will have their fetal growth assessed using twin-specific growth charts. These charts account for twin gestation norms and may influence clinical decision-making regarding growth restriction and perinatal management. The intervention does not involve any direct physical procedure or device but rather a change in the interpretation framework of routinely collected ultrasound data.

Singleton-Based Growth Chart Group

Participants in this arm will receive prenatal ultrasound assessments interpreted using a singleton-based growth chart for estimated fetal weight and biometry. Clinical decisions and perinatal risk assessments will be based on singleton percentiles, which represent standard practice in many settings.

Group Type: ACTIVE_COMPARATOR

Singleton-Based Growth Chart Interpretation

Intervention Type: OTHER

Participants in this arm will have their fetal growth assessed using singleton-based growth charts. These charts are commonly used in standard practice but may overestimate growth restriction in twin pregnancies. The intervention does not involve any direct physical procedure or device but alters the interpretation framework for standard prenatal ultrasound findings.

Interventions

Twin-Specific Growth Chart Interpretation

Participants in this arm will have their fetal growth assessed using twin-specific growth charts. These charts account for twin gestation norms and may influence clinical decision-making regarding growth restriction and perinatal management. The intervention does not involve any direct physical procedure or device but rather a change in the interpretation framework of routinely collected ultrasound data.

Intervention Type: OTHER

Singleton-Based Growth Chart Interpretation

Participants in this arm will have their fetal growth assessed using singleton-based growth charts. These charts are commonly used in standard practice but may overestimate growth restriction in twin pregnancies. The intervention does not involve any direct physical procedure or device but alters the interpretation framework for standard prenatal ultrasound findings.

Intervention Type: OTHER

Other Intervention Names

TWiST-Twin Chart; TWiST-Singleton Chart

Eligibility Criteria

Inclusion Criteria

• Pregnant individuals with a twin pregnancy of at least 18 weeks gestation.
• Willing and able to provide informed consent.
• Planning to deliver at a participating center.

Exclusion Criteria

• Major fetal anomalies or known aneuploidy.
• Significant maternal medical conditions that might confound study outcomes.
• Inability to comply with study procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Hiba Mustafa

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hiba Mustafa, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Central Contacts

Emrah Aydin, MD, PhD, MBA, MSc

Role: CONTACT

eaydin@iu.edu

5132202779

Other Identifiers

27427

Identifier Type: -

Identifier Source: org_study_id