Health TrialsbyHealthPanel

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

ConditionGastroschisis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study

Singleton pregnancy

Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)

Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound

Disqualifiers

Significant fetal anomaly unrelated to gastroschisis

Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)

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)

Placental abnormalities (previa, abruption, accreta) known at time of enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • fetoscopy

    Device

    The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the gastroschisis.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: fetoscopic surgical repairExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful Repair of Complex Gastroschisis

Success of primary skin closure after complete bowel reduction.

Time frame
At end of surgical repair

Secondary outcomes

1

Intrauterine Fetal Death (IUFD)

Demise of fetus while still in the womb

Time frame
At delivery
2

Preterm Birth

Number of patients that deliver at \< 37 weeks gestation

Time frame
At delivery
3

Time to initiation of enteral feeds (days)

The number of days until initiation of enteral feeding

Time frame
At hospital discharge, an average of 1.5 months
4

Time on total parenteral nutrition (TPN) (days)

The number of days on total parenteral nutrition (TPN)

Time frame
At hospital discharge, an average of 1.5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Source ClinicalTrials.gov
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