RECRUITING

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.

Official Title

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Quick Facts

Study Start:2023-10-20

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05704257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study 2. Singleton pregnancy 3. Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity) 4. Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound 5. Absence of significant associated anomalies\* diagnosed on prenatal ultrasound or MRI 6. Gestational age at the time of the procedure will be between 20 0/7 weeks and 25 6/7 weeks 7. Absence of chromosomal and clinically significant abnormalities, i.e., normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Results by fluorescence in situ hybridization (FISH) will be accepted, if the candidate's gestation age is ≥ 22 0/7 weeks. Patients declining invasive testing will be excluded 8. The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment 9. The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study) 10. Parental/guardian permission (informed consent) for follow up of the child after birth * Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the patient.	1. Significant fetal anomaly unrelated to gastroschisis 2. Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography) 3. Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication) 4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment 5. Pre-pregnancy body-mass index (BMI) ≥40 6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment 7. Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies 8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy. 9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment 10. Maternal medical condition that is a contraindication to surgery or general anesthesia 11. Low amniotic fluid volume (Amniotic Fluid Index less than 6 cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion 12. Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy 13. Inability to comply with the travel and follow-up requirements of the trial 14. Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS) 15. Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus 16. Maternal hypersensitivity to any of the entities associated w/ AlloDerm™. The use of AlloDerm™ Regenerative Tissue Matrix distributed by Allergan Aesthetics is contraindicated for patients sensitive to any of the antibiotics listed on the AlloDerm package, i.e., Gentamycin, Cefoxitin, Lincomycin, Polymyxin B and Vancomycin or Polysorbate 20

Inclusion Criteria

Exclusion Criteria

1. Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study
2. Singleton pregnancy
3. Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)
4. Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound
5. Absence of significant associated anomalies\* diagnosed on prenatal ultrasound or MRI
6. Gestational age at the time of the procedure will be between 20 0/7 weeks and 25 6/7 weeks
7. Absence of chromosomal and clinically significant abnormalities, i.e., normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Results by fluorescence in situ hybridization (FISH) will be accepted, if the candidate's gestation age is ≥ 22 0/7 weeks. Patients declining invasive testing will be excluded
8. The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment
9. The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)
10. Parental/guardian permission (informed consent) for follow up of the child after birth
* Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the patient.

1. Significant fetal anomaly unrelated to gastroschisis
2. Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)
3. Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)
4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
5. Pre-pregnancy body-mass index (BMI) ≥40
6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
7. Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
10. Maternal medical condition that is a contraindication to surgery or general anesthesia
11. Low amniotic fluid volume (Amniotic Fluid Index less than 6 cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion
12. Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
13. Inability to comply with the travel and follow-up requirements of the trial
14. Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)
15. Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus
16. Maternal hypersensitivity to any of the entities associated w/ AlloDerm™. The use of AlloDerm™ Regenerative Tissue Matrix distributed by Allergan Aesthetics is contraindicated for patients sensitive to any of the antibiotics listed on the AlloDerm package, i.e., Gentamycin, Cefoxitin, Lincomycin, Polymyxin B and Vancomycin or Polysorbate 20

Contacts and Locations

Study Contact

Sundeep Keswani, MD

CONTACT

832-824-0462

sgkeswan@texaschildrens.org

Becky Johnson

CONTACT

832-826-7451

rj2@bcm.edu

Principal Investigator

Sundeep Keswani, MD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine and Texas Children's Hospital

Study Locations (Sites)

Texas Children's Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Sundeep Keswani, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine and Texas Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20

Study Completion Date2029-12

Study Record Updates

Study Start Date2023-10-20

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Gastroschisis
Abdominal Wall Defect

Additional Relevant MeSH Terms

Gastroschisis