Clinical Trial: Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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).
  • 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.
  • Number of children delivered by cesarean section [ Time Frame: Immediately at birth ]
  • Number of children admitted to NICU [ Time Frame: Up to 6 weeks after delivery ]
    NICU is neo-natal intensive care unit
  • Number of children presenting with SGA [ Time Frame: Immediately at birth ]
    SGA is small for gestational age when birthweight <10% for gestational age


Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: February 6, 2017
Date Started: February 9, 2017
Date Completion: September 1, 2019
Last Updated: February 6, 2017
Last Verified: February 2017