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Completed

NCT Number: NCT03046355

Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

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.

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Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bellaire - Memorial Hermann, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Labor induction at 37.0 to 37.6 weeks of gestation

Procedure

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

Expectant monitoring until delivery

Procedure

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of children presenting with CNM

    Time frame: 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).

  2. Number of women presenting with CMM

    Time frame: 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.

  3. Number of children delivered by cesarean section

    Time frame: Immediately at birth

  4. Number of children admitted to NICU

    Time frame: Up to 6 weeks after delivery

    NICU is neo-natal intensive care unit

  5. Number of children presenting with SGA

    Time frame: Immediately at birth

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: GROW

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2017
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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