Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women (GROW)

The University of Texas System (UT)

Status: Completed

Conditions: Fetal Growth Restriction

Treatments: Procedure: Labor induction at 37.0 to 37.6 weeks of gestation; Procedure: Expectant monitoring until delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT03046355

HSC-MS-16-1053

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Labor induction at 37.0 to 37.6 weeks of gestation

Experimental group

Description:

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

Treatment:

Procedure: Labor induction at 37.0 to 37.6 weeks of gestation

Expectant monitoring until delivery

Active Comparator group

Description:

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Treatment:

Procedure: Expectant monitoring until delivery