BridgeMD
New treatment option for Gastroschisis
Official title Gastroschisis Outcomes of Delivery (GOOD) Study
ClinicalTrials.gov ID: NCT02774746
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- To be eligible for study inclusion, people 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
You likely can't join if
- people 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...
- 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
See the full eligibility criteria
- To be eligible for study inclusion, people 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.
- people 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Loma Linda, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- Wilmington, Delaware, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- Lousiville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
+ 13 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Loma Linda, California, United States; Stanford, California, United States; Aurora, Colorado, United States; Hartford, Connecticut, United States; Wilmington, Delaware, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.