Clinical Trial: Randomized Clinical Trial of Early Delivery in Fetal Gastroschisis vs. Routine Care

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Early Delivery in Fetal Gastroschisis: a Randomized Controlled Trial of Elective Early Delivery Versus Routine Obstetrical Care

Brief Summary:

Primary objective: to test the hypothesis that elective early delivery will protect the fetal bowel from the deleterious intrauterine factors late in the pregnancy and will be associated with improved neonatal outcomes.

Secondary objective: to introduce a standardized diagnostic, monitoring, and postnatal surgical management of infants with gastroschisis.


Detailed Summary:

Gastroschisis is a congenital malformation in which abdominal organs protrude through an abdominal wall defect, leading to considerable morbidity and mortality during infancy. In contrast to the second class of congenital abdominal wall defects, omphalocele, there is no association of gastroschisis with aneuploidy and there are no familial cohorts or heritability indices to suggest genetic etiology to gastroschisis. Although multiple population and cohort based-studies have implicated various environmental and maternal factors in the pathogenesis of gastroschisis (e.g. young age, smoking), the causes and mechanisms of this condition remain relatively unclear.

The herniated bowel often accumulates a fibrinous covering possibly due to inflammation induced by the amniotic fluid. There is usually a 25% or greater risk of intrauterine growth restriction with gastroschisis. Although long term intact survival is excellent (exceeding 95%), the associated morbidity is significant including gastrointestinal complications such as stricture, adhesions, and volvulus. Furthermore, there is a known association between fetal gastroschisis and late gestational intra-uterine fetal demise (IUFD). Late gestation IUFD is believed to result from acute volvulus of the small bowel and resultant bowel necrosis and death.

Until recently, there were no indications for early delivery, however; now there is mounting evidence supporting delivery at an earlier gestational age. This is supported with the prevailing hypothesis that early delivery prevents further insult from the amniotic fluid to the small bowel. However, these hypotheses have yet to be examined in a well designed, adequately powered, randomized clinical trial. Consequently, it is our primary objective to test the hypothesis that elective early delivery will protect the fetal bowel from t
Sponsor: Baylor College of Medicine

Current Primary Outcome: Time on total parenteral nutrition [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Diagnostic/Antepartum, Postnatal management [ Time Frame: 3 years ]

  1. Diagnostic/Antepartum (diagnostic/monitoring):

    - To evaluate the utility of sonographic markers in predicting neonatal outcome (including simple versus complex), which will include individualized growth potential, size of defect, intra-abdominal bowel wall thickness and dilation, extra-abdominal bowel wall thickness and dilation, umbilical artery Doppler indices, and biophysical profile

  2. Postnatal management:

    • To evaluate the utility of a standardized surgical protocol by comparing short term operative outcomes between neonates enrolled under this protocol versus historical controls from Texas Children's Hospital (from preceding 10 years).
    • To evaluate the utility of a standardized feeding protocol by comparing neonatal outcomes including weight gain, days on TPN, and NEC between neonates enrolled under this protocol versus historical controls from Texas Children's Hospital (from preceding 10 years).


Original Secondary Outcome: to introduce a standardized diagnostic, monitoring, and postnatal surgical management of infants with gastroschisis. [ Time Frame: 3 years ]

Information By: Baylor College of Medicine

Dates:
Date Received: June 19, 2013
Date Started: June 2013
Date Completion: April 2018
Last Updated: September 21, 2016
Last Verified: September 2016