Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women: A Randomized Controlled Trial (GROW Trial)

The University of Texas Health Science Center, Houston3 sites in 1 country21 target enrollmentMarch 13, 2017

ConditionsFetal Growth Restriction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fetal Growth Restriction
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 21
Locations: 3
Primary Endpoint: Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can improve the baby's health at birth when compared with delivery at a later point in the pregnancy.

Registry

clinicaltrials.gov

Start Date

March 13, 2017

End Date

March 18, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Bahaeddine M Sibai

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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)
•FGR defined as estimated fetal weight (EFW) \< 10th percentile by Hadlock formula with normal umbilical artery Doppler studies and normal amniotic fluid

Exclusion Criteria

•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)

Outcomes

Primary Outcomes

Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms

Time Frame: Immediately at birth

NICHD is National Institute of Child Health and Human Development The NICHD nomogram will indicate their birth weight percentile based on their gestational age and ethnicity