Clinical trial NCT03046355: Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women
Official title: Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women: A Randomized Controlled Trial (GROW Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Growth Restriction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* 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

Primary outcomes:
measure: Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms
timeFrame: Immediately at birth
Secondary outcomes:
measure: Number of children presenting with CNM
timeFrame: Up to 6 weeks after delivery
measure: Number of women presenting with CMM
timeFrame: Up to 6 weeks after delivery
measure: Number of children delivered by cesarean section
timeFrame: Immediately at birth
measure: Number of children admitted to NICU
timeFrame: Up to 6 weeks after delivery
measure: Number of children presenting with SGA
timeFrame: Immediately at birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Memorial City Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Bellaire - Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Baha M Sibai, MD
role: PRINCIPAL_INVESTIGATOR
References: