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

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ClinicalTrials.gov Identifier: NCT01884324
Recruitment Status : Terminated (Study was stoped according to preliminary analysis.)
First Posted : June 24, 2013
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Alireza Abdollah Shamshirsaz, Baylor College of Medicine

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.


Condition or disease Intervention/treatment Phase
Gastroschisis Other: Early Delivery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Delivery in Fetal Gastroschisis: a Randomized Controlled Trial of Elective Early Delivery Versus Routine Obstetrical Care
Study Start Date : June 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Late delivery
This will be a randomized clinical investigation. The subjects will be allocated into "early" and "late" delivery groups using concealed allocation envelopes, which will be created prior to the start of the study using a random allocation sequence. The trial will be conducted in an intent-to-treat fashion.
Experimental: Early delivery
The early group will undergo induction of labor at 34 weeks with cesarean delivery reserved for obstetrical indications.
Other: Early Delivery
This will be a randomized clinical investigation. The subjects will be allocated into "early" and "late" delivery groups using concealed allocation envelopes, which will be created prior to the start of the study using a random allocation sequence. The trial will be conducted in an intent-to-treat fashion.




Primary Outcome Measures :
  1. Time on total parenteral nutrition [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant
  2. 16-50 years of age
  3. Prenatal diagnosis of fetal gastroschisis
  4. Less than 34 weeks and 0 days gestation

Exclusion Criteria:

  1. Greater than 34 weeks gestation
  2. 2. Fetus with massive gastroschisis defect that is not treatable after delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884324


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Alireza A Shamshirsaz, M.D. Baylor College of Medicine
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Responsible Party: Alireza Abdollah Shamshirsaz, Faculty Instructor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01884324    
Other Study ID Numbers: H-29862
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by Alireza Abdollah Shamshirsaz, Baylor College of Medicine:
Gastroschisis
Cesarean delivery
Neonatal outcomes
Additional relevant MeSH terms:
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Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical