Back to resultsEarly Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA)
Primary Purpose
Macrosomia, Fetal, Labor Induction
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Labor induction at 37.0 weeks to 37.6 weeks of gestation
Expectant monitoring and delivery
Sponsored by
About this trial
This is an interventional prevention trial for Macrosomia, Fetal focused on measuring large for gestational age fetal growth
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Labor induction at 37.0 weeks to 37.6 weeks of gestation
Expectant monitoring and delivery
Arm Description
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
Outcomes
Primary Outcome Measures
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.
Number of children with birthweight above 4500 grams
Secondary Outcome Measures
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.
Number of children delivered by cesarean section
Number of children admitted to NICU
NICU is neo-natal intensive care unit
Full Information
NCT ID
NCT03218735
First Posted
July 12, 2017
Last Updated
December 21, 2017
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic
1. Study Identification
Unique Protocol Identification Number
NCT03218735
Brief Title
Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus
Acronym
TEAM LGA
Official Title
Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus (TEAM LGA Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
It was discovered that the patient population would not be large enough to adequately recruit.
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macrosomia, Fetal, Labor Induction
Keywords
large for gestational age fetal growth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Labor induction at 37.0 weeks to 37.6 weeks of gestation
Arm Type
Experimental
Arm Description
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Arm Title
Expectant monitoring and delivery
Arm Type
Active Comparator
Arm Description
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
Intervention Type
Procedure
Intervention Name(s)
Labor induction at 37.0 weeks to 37.6 weeks of gestation
Intervention Description
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Intervention Type
Procedure
Intervention Name(s)
Expectant monitoring and delivery
Intervention Description
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
Primary Outcome Measure Information:
Title
Number of children presenting with CNM
Description
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.
Time Frame
Up to 6 weeks after delivery
Title
Number of children with birthweight above 4500 grams
Time Frame
Immediately at birth
Secondary Outcome Measure Information:
Title
Number of women presenting with CMM
Description
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.
Time Frame
Up to 6 weeks after delivery
Title
Number of children delivered by cesarean section
Time Frame
Immediately at birth
Title
Number of children admitted to NICU
Description
NICU is neo-natal intensive care unit
Time Frame
Up to 6 weeks after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baha M Sibai, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus
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