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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Labor Induction; Macrosomia, Fetal
• Intervention / Treatment: Procedure: Labor induction at 37.0 weeks to 37.6 weeks of gestation; Procedure: Expectant monitoring and delivery

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Labor induction at 37.0 weeks to 37.6 weeks of gestation; Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days	Procedure: Labor induction at 37.0 weeks to 37.6 weeks of gestation; Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
ACTIVE_COMPARATOR: Expectant monitoring and delivery; Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices	Procedure: Expectant monitoring and delivery; Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children presenting with CNM	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.	Up to 6 weeks after delivery
Number of children with birthweight above 4500 grams		Immediately at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children delivered by cesarean section		Immediately at birth
Number of children admitted to NICU	NICU is neo-natal intensive care unit	Up to 6 weeks after delivery
Number of women presenting with CMM	Composite maternal morbidity (CMM) is any of the following: chorioamnionitis, shoulder dystocia, 3rd or 4th degree laceration or episiotomy, transfusion of blood products, endometritis, wound infection or separation, deep venous thrombosis, pulmonary embolism, admission to the intensive care unit, or death. Rates of cesarean section as well as indications in each group will also be evaluated.	Up to 6 weeks after delivery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic
• Investigators: Principal Investigator: Baha M Sibai, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2017
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: large for gestational age fetal growth
• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Body Weight; Fetal Diseases; Pregnancy Complications; Diabetes, Gestational; Pregnancy in Diabetics; Birth Weight; Fetal Macrosomia
• Other Study ID Numbers: HSC-MS-17-0110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No