Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Fetal Growth Restriction

Intervention / Treatment
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* Procedure: Labor induction at 37.0 to 37.6 weeks of gestation
* Procedure: Expectant monitoring until delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Labor induction at 37.0 to 37.6 weeks of gestation<br>Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days | Procedure: Labor induction at 37.0 to 37.6 weeks of gestation<br>* Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days<br>|
| Active Comparator: Expectant monitoring until delivery<br>Diagnosis of FGR managed with expectant monitoring and delivery as indicated | Procedure: Expectant monitoring until delivery<br>* Diagnosis of FGR managed with expectant monitoring and delivery as indicated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms | 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 | Immediately at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children presenting with CNM | Composite neo-natal morbidity (CNM) is any of the following: Apgar score <5 at 5 minutes, seizure, sepsis, hypoglycemia requiring intravenous treatment, mechanical ventilation, CPAP (continuous positive airway pressure) or high-flow nasal cannula for >2 hours, oxygen supplementation with FiO2 (fraction of inspired oxygen) >30% for >4 hours, death before discharge or IUFD (intrauterine fetal death). | Up to 6 weeks after delivery | 
| Number of women presenting with CMM | Composite maternal morbidity (CMM) is any of the following: chorioamnionitis, 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 | 
| Number of children delivered by cesarean section |  | Immediately at birth | 
| Number of children admitted to NICU | NICU is neo-natal intensive care unit | Up to 6 weeks after delivery | 
| Number of children presenting with SGA | SGA is small for gestational age when birthweight <10% for gestational age | Immediately at birth |