Twins With Specific vs. Traditional Fetal Growth Charts

NCT07164001 | Not Yet Recruiting DMC

• 1 other identifier: 27427
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Twin Pregnancy

Keywords

Twin-Specific Growth Chart; Singleton-Based Growth Chart; Fetal Biometry; Small for Gestational Age; Growth Assessment; Perinatal Outcomes; Randomized Controlled Trial; Prenatal Ultrasound; Twin Gestation

Outcome Measures

Primary Outcomes (1)

• Rate of Small for Gestational Age (SGA) Diagnosis Based on Ultrasound Biometry

  The primary outcome is the incidence of small for gestational age (SGA) diagnosis among twin pregnancies, as determined by fetal biometry assessed during prenatal ultrasound using either twin-specific or singleton-based growth charts. SGA is defined as an estimated fetal weight below the 10th percentile for gestational age according to the respective chart used in each study arm.

  At delivery (up to 42 weeks gestation)

Secondary Outcomes (4)

• Rate of Neonatal Composite Morbidity

  Delivery through neonatal hospital discharge (up to 28 days of life)

• Rate of NICU Admission

  At delivery

• Birthweight Discordance Between Twins

  At delivery

• Gestational Age at Delivery

  At delivery

Study Arms (2)

Twin-Specific Growth Chart Group

EXPERIMENTAL

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.

Other: Twin-Specific Growth Chart Interpretation

Singleton-Based Growth Chart Group

ACTIVE COMPARATOR

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.

Other: Singleton-Based Growth Chart Interpretation

Interventions

Twin-Specific Growth Chart Interpretation 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.

Also known as: TWiST-Twin Chart

Twin-Specific Growth Chart Group

Singleton-Based Growth Chart Interpretation 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.

Also known as: TWiST-Singleton Chart

Singleton-Based Growth Chart Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Officials

• Hiba Mustafa, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emrah Aydin, MD, PhD, MBA, MSc

CONTACT

5132202779; eaydin@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants with twin pregnancies are randomly assigned to either the intervention arm (twin-specific fetal growth chart) or the control arm (singleton-based fetal growth chart). The two groups will be followed in parallel throughout the study period to compare diagnostic accuracy and clinical outcomes. No crossover between arms will occur. Ultrasound measurements and clinical decision-making will adhere to the assigned chart type.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): January 28, 2030
• Last Updated: September 15, 2025

Record last verified: 2025-09