Is NCT05704257 recruiting in Houston, TX?

Yes, NCT05704257 is currently recruiting participants at its Houston, TX location. This gastroschisis clinical trial is actively enrolling qualified participants.

How do I join the gastroschisis clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Gastroschisis Clinical Trial in Houston, TX

About This Gastroschisis Study in Houston

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.

Sponsor: Baylor College of Medicine

Who Can Participate

Inclusion Criteria

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

Absence of significant associated anomalies\

diagnosed on prenatal ultrasound or MRI

Gestational age at the time of the procedure will be between 20 0/7 weeks and 27 6/7 weeks

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

The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment

The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)

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.

Exclusion Criteria

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

Pre-pregnancy body-mass index (BMI) ≥40

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

Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies

Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.

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

Maternal medical condition that is a contraindication to surgery or general anesthesia

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

Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy

Inability to comply with the travel and follow-up requirements of the trial

Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)

Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT05704257) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Gastroschisis Treatment Options in Houston, TX

If you're searching for gastroschisis treatment options in Houston, TX, this clinical trial (NCT05704257) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gastroschisis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all gastroschisis clinical trials near you to find additional studies recruiting in your area.

Gastroschisis Clinical Trial in Houston, TX

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