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

Primary Purpose

Fetal Growth Restriction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Labor induction at 37.0 to 37.6 weeks of gestation

Expectant monitoring until delivery

About this trial

This is an interventional treatment trial for Fetal Growth Restriction

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Memorial Hermann Memorial City Medical Center
The University of Texas Health Science Center at Houston
Bellaire - Memorial Hermann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Labor induction at 37.0 to 37.6 weeks of gestation

Expectant monitoring until delivery

Arm Description

Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

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.

Number of children delivered by cesarean section

Number of children admitted to NICU

NICU is neo-natal intensive care unit

Number of children presenting with SGA

SGA is small for gestational age when birthweight <10% for gestational age

Full Information

NCT ID

NCT03046355

First Posted

February 6, 2017

Last Updated

June 11, 2019

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT03046355

Brief Title

Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

Acronym

GROW

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 13, 2017 (Actual)

Primary Completion Date

March 18, 2019 (Actual)

Study Completion Date

March 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fetal Growth Restriction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Labor induction at 37.0 to 37.6 weeks of gestation

Arm Type

Experimental

Arm Description

Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days

Arm Title

Expectant monitoring until delivery

Arm Type

Active Comparator

Arm Description

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Intervention Type

Procedure

Intervention Name(s)

Labor induction at 37.0 to 37.6 weeks of gestation

Intervention Description

Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days

Intervention Type

Procedure

Intervention Name(s)

Expectant monitoring until delivery

Intervention Description

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Primary Outcome Measure Information:

Title

Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms

Description

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

Time Frame

Immediately at birth

Secondary Outcome Measure Information:

Title

Number of children presenting with CNM

Description

Time Frame

Up to 6 weeks after delivery

Title

Number of women presenting with CMM

Description

Time Frame

Up to 6 weeks after delivery

Title

Number of children delivered by cesarean section

Time Frame

Immediately at birth

Title

Number of children admitted to NICU

Description

NICU is neo-natal intensive care unit

Time Frame

Up to 6 weeks after delivery

Title

Number of children presenting with SGA

Description

SGA is small for gestational age when birthweight <10% for gestational age

Time Frame

Immediately at birth

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baha M Sibai, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Hermann Memorial City Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Bellaire - Memorial Hermann

City

Houston

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

12. IPD Sharing Statement

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Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

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