Health TrialsbyHealthPanel

Twins With Specific vs. Traditional Fetal Growth Charts

ConditionTwin Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Major fetal anomalies or known aneuploidy.

Significant maternal medical conditions that might confound study outcomes.

Inability to comply with study procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Twin-Specific Growth Chart Interpretation

    Other intervention

    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 Interpretation

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Twin-Specific Growth Chart GroupExperimental treatment 1 intervention
Group B: Singleton-Based Growth Chart GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
At delivery (up to 42 weeks gestation)

Secondary outcomes

1

Rate of Neonatal Composite Morbidity

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.

Time frame
Delivery through neonatal hospital discharge (up to 28 days of life)
2

Rate of NICU Admission

Percentage of neonates admitted to the Neonatal Intensive Care Unit (NICU) following delivery, as documented in clinical records.

Time frame
At delivery
3

Birthweight Discordance Between Twins

Defined as the percentage difference in birthweight between the two fetuses in each twin pair. Discordance \>20% will be considered clinically significant.

Time frame
At delivery
4

Gestational Age at Delivery

Measured in completed weeks of gestation at the time of birth, based on clinical and ultrasound dating.

Time frame
At delivery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: