Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus

Labor Induction Clinical Trial

— TEAM LGA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03218735
• Other study ID #: HSC-MS-17-0110
• Status: Withdrawn
• Phase: N/A
• First received: July 12, 2017
• Last updated: December 21, 2017
• Start date: July 12, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: December 2017
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Macrosomia
• Labor Induction
• Macrosomia, Fetal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of children with birthweight above 4500 grams		Immediately at birth
Secondary	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
Secondary	Number of children delivered by cesarean section		Immediately at birth
Secondary	Number of children admitted to NICU	NICU is neo-natal intensive care unit	Up to 6 weeks after delivery