Twin Pregnancy
Conditions
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
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.
Interventions
OTHERTwin-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.
OTHERSingleton-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.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Small for Gestational Age (SGA) Diagnosis Based on Ultrasound Biometry | At delivery (up to 42 weeks gestation) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Neonatal Composite Morbidity | Delivery through neonatal hospital discharge (up to 28 days of life) | Composite includes one or more of the following: CPAP use \>72 hours, intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), neonatal hypoglycemia requiring IV therapy, or neonatal death. |
| Rate of NICU Admission | At delivery | Percentage of neonates admitted to the Neonatal Intensive Care Unit (NICU) following delivery, as documented in clinical records. |
| Birthweight Discordance Between Twins | At delivery | Defined as the percentage difference in birthweight between the two fetuses in each twin pair. Discordance \>20% will be considered clinically significant. |
| Gestational Age at Delivery | At delivery | Measured in completed weeks of gestation at the time of birth, based on clinical and ultrasound dating. |
Contacts
Primary ContactEmrah Aydin, MD, PhD, MBA, MSc
Outcome results
None listed