Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

Fetal Growth Restriction Clinical Trial

— GROW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046355
• Other study ID #: HSC-MS-16-1053
• Status: Completed
• Phase: N/A
• Start date: March 13, 2017
• Est. completion date: March 18, 2019

Study information

• Verified date: June 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation

Intervention

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
• Expectant monitoring until delivery
Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Locations

Country	Name	City	State
United States	Bellaire - Memorial Hermann	Houston	Texas
United States	Memorial Hermann Memorial City Medical Center	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of children delivered by cesarean section		Immediately at birth
Secondary	Number of children admitted to NICU	NICU is neo-natal intensive care unit	Up to 6 weeks after delivery
Secondary	Number of children presenting with SGA	SGA is small for gestational age when birthweight <10% for gestational age	Immediately at birth