Gastroschisis Outcomes of Delivery (GOOD) Study

Launched by MEDICAL COLLEGE OF WISCONSIN · May 12, 2016

Keywords

ClinConnect Summary

The GOOD Study is a clinical trial aimed at understanding the best timing for delivering babies diagnosed with gastroschisis, a condition where the intestines are outside the body at birth. The researchers want to find out if delivering the baby at 35 weeks of pregnancy is better than waiting until 38 weeks. The study will involve various hospitals and will include women who are at least 18 years old, speak English or Spanish, and have a confirmed diagnosis of isolated gastroschisis by 33 weeks of pregnancy. Participants will be randomly assigned to either have their baby at 35 weeks or to continue with regular monitoring until 38 weeks.

If you join this trial, you can expect close monitoring of both your health and your baby's health. The main goal is to see how early delivery affects outcomes like survival rates and the need for special care after birth. It's important to know that certain health conditions, such as severe growth issues for the baby or significant health problems for the mother, might prevent you from participating. This study is currently recruiting, so there is an opportunity to contribute to important research that could improve care for babies with gastroschisis.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• To be eligible for study inclusion, subjects are required to meet the following criteria:
• • 1. Speak English or Spanish
• • 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 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
• • 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
• • 1. 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
• • 2. Umbilical artery Dopplers with S/D ratio or resistive index (RI) \> 97th percentile for age with or without absent or reversed end diastolic flow
• • 3. Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician
• • 11. 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
• • 12. Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate
• • 13. Incapable of providing informed consent
• • 14. Are not their own legally authorized representative.