Atlanta, GANCT02774746Now EnrollingIRB Ready

Gastroschisis Clinical Trial in Atlanta, GA

Access cutting-edge gastroschisis treatment through this clinical trial at a research site in Atlanta. Study-provided care at no cost to qualified participants.

Sponsored by Medical College of Wisconsin

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Expert Care in Atlanta

Access gastroschisis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related gastroschisis treatment provided free

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Check if you qualify for this gastroschisis clinical trial in Atlanta, GA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Atlanta

    Convenient for GA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Atlanta site if eligible
  4. 4Begin participation

About This Gastroschisis Study in Atlanta

The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.

Sponsor: Medical College of Wisconsin

Who Can Participate

Inclusion Criteria

To be eligible for study inclusion, subjects are required to meet the following criteria:
Speak English or Spanish
Age of ≥18 years old
Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation
Have a singleton pregnancy
Capable of providing written informed consent for study participation
Established Estimated Date of Confinement (EDC) prior to 22 0/7 weeks GA by last menstrual period (LMP) with ultrasound confirmation or ultrasound dating when LMP is unknown.

Exclusion Criteria

Subjects will be excluded from enrollment for any of the following criteria
Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)
Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)
Maternal history of previous stillbirth (intrauterine fetal demise)
Maternal history of spontaneous preterm (\<36 weeks) delivery
Maternal cervical length \< 25 mm prior to 24 weeks of gestation if documented
Maternal hypertension
Maternal insulin-dependent diabetes
Prenatal care initiated after 24 weeks of gestation
An active case of COVID-19 (confirmed by a positive test for COVID-19) that is not recovered (confirmed by a negative test for COVID-19) by the date of randomization
Unstable pregnancy defined as meeting any of the following criteria
Abnormal amniotic fluid volume defined as oligohydramnios or polyhydramnios where the maximal vertical pocket (MVP) is \< 2 cm or \> 8 cm in the third trimester, respectively
Umbilical artery Dopplers with S/D ratio or resistive index (RI) \> 97th percentile for age with or without absent or reversed end diastolic flow
Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician
Concurrent enrollment in another study that requires either a treatment or intervention which would either alter the delivery plan or potentially influence the maternal, fetal, and neonatal outcomes of this study
Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate
Incapable of providing informed consent
Are not their own legally authorized representative.

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 Atlanta?

Yes, this clinical trial (NCT02774746) has an active research site in Atlanta, GA 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 Atlanta, GA

If you're searching for gastroschisis treatment options in Atlanta, GA, this clinical trial (NCT02774746) 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 Atlanta 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.

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