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Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus | Clinical Trials | Clareo Health

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

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

NCT03218735•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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

Age

18 - 39 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Singleton pregnancy
•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
+14 more criteria

Key Dates

Start Date

July 12, 2017

Primary Completion Date

July 1, 2019

Completion Date

August 1, 2019

Last Updated

December 26, 2017

Conditions

Macrosomia, FetalLabor Induction

Interventions

Labor induction at 37.0 weeks to 37.6 weeks of gestation

PROCEDURE

Expectant monitoring and delivery

PROCEDURE

Lifestyle Intervention in Preparation for Pregnancy (LIPP)

NCT03146156

ObesityLifestyle-related Condition+1 more

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COMPLETED

Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

NCT04075630

Labor Induction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Lifestyle Intervention in Preparation for Pregnancy (LIPP)

Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

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