Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA)

The University of Texas System (UT)

Status: Withdrawn

Conditions: Labor Induction; Macrosomia, Fetal

Treatments: Procedure: Labor induction at 37.0 weeks to 37.6 weeks of gestation; Procedure: Expectant monitoring and delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT03218735

HSC-MS-17-0110

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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
• History of classical cesarean section or myomectomy
• Human immunodeficiency virus (HIV)
• Oligohydramnios (low amniotic fluid, defined as maximum vertical pocket <2.0cm)
• High-risk pregnancy as determined by the physician. Common examples include:
• Pre-gestational diabetes or gestational diabetes on medication
• Chronic hypertension on medication
• Maternal cardiac disease
• Asthma requiring oral steroids during pregnancy
• Chronic renal disease
• Antiphospholipid syndrome
• Hyperthyroidism
• Prior stillbirth
• Systemic lupus erythematous
• Hemoglobinopathies such as sickle cell disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Labor induction at 37.0 weeks to 37.6 weeks of gestation

Experimental group

Description:

Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days

Treatment:

Procedure: Labor induction at 37.0 weeks to 37.6 weeks of gestation

Expectant monitoring and delivery

Active Comparator group

Description:

Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices

Treatment:

Procedure: Expectant monitoring and delivery