GROW: Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT03046355

Collaborator

(none)

Enrollment

Locations

Arms

24.1

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Growth Restriction	Procedure: Labor induction at 37.0 to 37.6 weeks of gestation Procedure: Expectant monitoring until delivery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 13, 2017

Actual Primary Completion Date :

Mar 18, 2019

Actual Study Completion Date :

Mar 18, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Hermann Memorial City Medical Center	Houston	Texas	United States	77024
2	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
3	Bellaire - Memorial Hermann	Houston	Texas	United States	77401

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bahaeddine M Sibai, Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT03046355

Other Study ID Numbers:

HSC-MS-16-1053

First Posted:

Feb 8, 2017

Last Update Posted:

Jun 13, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fetal Growth Retardation

Study Results

No Results Posted as of Jun 13, 2019