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

NCT03218735 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-12-26

No results posted yet for this study

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.

Conditions

  • Macrosomia, Fetal
  • Labor Induction

Interventions

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

PROCEDURE

Expectant monitoring and delivery

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

Sponsors & Collaborators

  • Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Baha M Sibai, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-12
Primary Completion
2019-07-01
Completion
2019-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03218735 on ClinicalTrials.gov