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

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

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.

Study Overview

• Status: Completed
• Conditions: Fetal Growth Restriction
• Intervention / Treatment: Procedure: Labor induction at 37.0 to 37.6 weeks of gestation; Procedure: Expectant monitoring until delivery

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77024
      • Memorial Hermann Memorial City Medical Center
    • Houston, Texas, United States, 77401
      • Bellaire - Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Labor 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	Procedure: Labor 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
ACTIVE_COMPARATOR: Expectant monitoring until delivery; Diagnosis of FGR managed with expectant monitoring and delivery as indicated	Procedure: Expectant monitoring until delivery; Diagnosis of FGR managed with expectant monitoring and delivery as indicated

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Baha M Sibai, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2017
• Primary Completion (ACTUAL): March 18, 2019
• Study Completion (ACTUAL): March 18, 2019

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (ESTIMATE): February 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: HSC-MS-16-1053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No