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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03218735

Collaborator

Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic (Other)

Enrollment

Arms

24.6

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Macrosomia, Fetal Labor Induction	Procedure: Labor induction at 37.0 weeks to 37.6 weeks of gestation Procedure: Expectant monitoring and delivery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 12, 2017

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of children presenting with CNM [Up to 6 weeks after delivery]
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 [Immediately at birth]

Secondary Outcome Measures

Number of women presenting with CMM [Up to 6 weeks after delivery]
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 [Immediately at birth]
Number of children admitted to NICU [Up to 6 weeks after delivery]
NICU is neo-natal intensive care unit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bahaeddine M Sibai, Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT03218735

Other Study ID Numbers:

HSC-MS-17-0110

First Posted:

Jul 17, 2017

Last Update Posted:

Dec 26, 2017

Last Verified:

Dec 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bahaeddine M Sibai, Professor, The University of Texas Health Science Center, Houston

large for gestational age fetal growth

Additional relevant MeSH terms:

Fetal Macrosomia

Study Results

No Results Posted as of Dec 26, 2017