Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Macrosomia, Fetal
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary Endpoint
- Number of children with birthweight above 4500 grams
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to compare the incidence of composite neonatal morbidity and birthweight >4500 grams among uncomplicated large for gestational age (LGA) fetal growth at delivered 37 weeks versus expectant management.
Investigators
Bahaeddine M Sibai
Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •Singleton pregnancy
- •Plan for vaginal delivery. Patients with prior cesarean section are eligible if they are planning for a trial of labor after cesarean section.
- •Gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment
- •Dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound \<21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization
- •No known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician)
- •LGA defined as estimated fetal weight (EFW) \> 90th percentile by Hadlock formula but \<4500 grams
Exclusion Criteria
- •Pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin)
- •Planned cesarean delivery
- •Polyhydramnios
- •Known major fetal anomalies
- •Multiple gestation or selective reduction of multiple gestation after 14 weeks
- •Previous stillbirth at term
- •Indications for delivery at \<39 weeks. Common examples include:
- •Placenta previa
- •Placenta accreta
- •Vasa previa
Outcomes
Primary Outcomes
Number of children with birthweight above 4500 grams
Time Frame: Immediately at birth
Number of children presenting with CNM
Time Frame: Up to 6 weeks after delivery
Composite neonatal morbidity (CNM) is any of the following: Apgar score \<5 at 5 minutes, seizure, fracture of skull, humerus, or clavicle, neonatal brachial plexus palsy, facial nerve palsy, oxygen supplementation \>4 hours, CPAP \>2 hours, mechanical ventilation, or death before discharge or IUFD.
Secondary Outcomes
- Number of children delivered by cesarean section(Immediately at birth)
- Number of children admitted to NICU(Up to 6 weeks after delivery)
- Number of women presenting with CMM(Up to 6 weeks after delivery)