Details

IRB Study Number 22-274

Status Recruiting

Location M Building - Cleveland Clinic Children's

Institute Obstetrics and Gynecology and Women's Health Institute

Description

Description

This project is being done to compare the two treatment plans for delivery of babies with gastroschisis: delivering early at 35 weeks gestation or continuing pregnancy to observed delivery with a goal of delivering at 38 weeks.

The trial is endorsed by the North American Fetal Therapy Network (NAFTNet) [http://www.naftnet.org]. NAFTNet is an association of tertiary-care centers specializing in fetal surgery and complex fetal disorders. NAFTNet centers house multidisciplinary teams of surgeons and specialists dedicated to providing the best fetal and neonatal care available, which minimizes confounders related to quality of care. By recruiting patients from participating sites within the network we ensure that the subjects will get the best care modern medicine can provide and allow the most controlled environment for collecting data.

Inclusion Criteria

Inclusion Criteria

  1. Speak English

  2. Age of ≥18 years old

  3. Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation

  4. Have a singleton pregnancy

  5. Capable of providing written informed consent for study participation

  6. Established Estimated Date of Confinement (EDC) prior to 22 0/7 weeks GA by last 300 menstrual period (LMP) with ultrasound confirmation or ultrasound dating when LMP is unknown.

Exclusion Criteria

Exclusion Criteria

  1. Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)

  2. Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)

  3. Maternal history of previous stillbirth (intrauterine fetal demise)

  4. Maternal history of spontaneous preterm (<36 weeks) delivery

  5. Maternal cervical length < 25 mm prior to 24 weeks of gestation if documented

  6. Maternal hypertension

  7. Maternal insulin-dependent diabetes

  8. Prenatal care initiated after 24 weeks of gestation

  9. 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

  10. Unstable pregnancy defined as meeting any of the following criteria

a. 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

b. Umbilical artery Dopplers with S/D ratio or resistive index (RI) > 97th percentile for age with or without absent or reversed end diastolic flow

c. Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician

  1. 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

  2. Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate

  3. Incapable of providing informed consent

  4. Are not their own legally authorized representative.