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

December 21, 2017 updated by: Bahaeddine M Sibai, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of children presenting with CNM
Time Frame: 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.
Up to 6 weeks after delivery
Number of children with birthweight above 4500 grams
Time Frame: Immediately at birth
Immediately at birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of children delivered by cesarean section
Time Frame: Immediately at birth
Immediately at birth
Number of children admitted to NICU
Time Frame: Up to 6 weeks after delivery
NICU is neo-natal intensive care unit
Up to 6 weeks after delivery
Number of women presenting with CMM
Time Frame: 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.
Up to 6 weeks after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Baha M Sibai, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-17-0110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor Induction

Clinical Trials on Labor induction at 37.0 weeks to 37.6 weeks of gestation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings