Fetal Growth Restriction
Conditions
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.
Interventions
PROCEDURELabor induction at 37.0 to 37.6 weeks of gestation
Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
PROCEDUREExpectant monitoring until delivery
Diagnosis of FGR managed with expectant monitoring and delivery as indicated
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of children presenting with CNM | Up to 6 weeks after delivery | 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). |
| Number of women presenting with CMM | Up to 6 weeks after delivery | 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. |
| Number of children delivered by cesarean section | Immediately at birth | — |
| Number of children admitted to NICU | Up to 6 weeks after delivery | NICU is neo-natal intensive care unit |
| Number of children presenting with SGA | Immediately at birth | SGA is small for gestational age when birthweight \<10% for gestational age |
Countries
United States
Outcome results
None listed