Clinical trial NCT03218735: Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus
Official title: Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Macrosomia, Fetal
Labor Induction
Keywords: large for gestational age fetal growth
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic
First posted: 2017-07-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: Number of children presenting with CNM
timeFrame: Up to 6 weeks after delivery
measure: Number of children with birthweight above 4500 grams
timeFrame: Immediately at birth
Secondary outcomes:
measure: Number of women presenting with CMM
timeFrame: Up to 6 weeks after delivery
measure: Number of children delivered by cesarean section
timeFrame: Immediately at birth
measure: Number of children admitted to NICU
timeFrame: Up to 6 weeks after delivery
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Baha M Sibai, MD
role: PRINCIPAL_INVESTIGATOR
References: