NCT03218735

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

July 12, 2017

Last Update Submit

December 21, 2017

Conditions

Macrosomia, FetalLabor Induction

Keywords

large for gestational age fetal growth

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 6 weeks after delivery

  • Number of children with birthweight above 4500 grams

    Immediately at birth

Secondary Outcomes (3)

  • Number of women presenting with CMM

    Up to 6 weeks after delivery

  • Number of children delivered by cesarean section

    Immediately at birth

  • Number of children admitted to NICU

    Up to 6 weeks after delivery

Study Arms (2)

Labor induction at 37.0 weeks to 37.6 weeks of gestation

EXPERIMENTAL

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

Expectant monitoring and delivery

ACTIVE COMPARATOR

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

Procedure: Expectant monitoring and delivery

Interventions

Labor induction at 37.0 weeks to 37.6 weeks of gestationPROCEDURE

Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days

Labor induction at 37.0 weeks to 37.6 weeks of gestation
Expectant monitoring and deliveryPROCEDURE

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

Expectant monitoring and delivery

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Macrosomia

Interventions

PregnancyParturition

Condition Hierarchy (Ancestors)

Diabetes, GestationalPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Baha M Sibai, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 17, 2017

Study Start

July 12, 2017

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

December 26, 2017

Record last verified: 2017-12