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Fetal Surgery for Spina Bifida
Study Summary
This trial is testing offering pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with a BMI of 35-40 kg/m2, diabetes, a history of a previous preterm birth, or a structural abnormality in the fetus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have other serious health issues like high blood pressure or kidney problems.My unborn baby has been diagnosed with myelomeningocele.My BMI before pregnancy was between 35 and 45.I have had a heart attack, stroke, or TIA in the last year.My blood sugar control is poor (HbA1c ≥ 8%) despite taking diabetes medication.I have unstable chest pain.I have a low level of Rh antibodies without causing fetal disease.I have diabetes with well-controlled blood sugar levels.I do not have severe complications from diabetes like blindness or kidney failure.
- Group 1: Fetal Surgery in Women with ex
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who has the requisite qualifications to be accepted into this clinical trial?
"This study is enrolling forty individuals aged between sixteen and forty-five who have obesity. In addition to this requirement, pregnant women with a prenatal diagnosis of myelomeningocele; pre-pregnancy BMI of 35–45 kg/m2; diabetes but good glycemic control; prior history of preterm birth as long as followed by full term births; minor structural abnormalities in the fetus such as cleft lip or palate, minor ventricular septal defect, pyelectasis; low level anti-red blood cell antibody that is not associated with fetal disease specifically anti-E lower than 1:4 or anti M"
Is there a call for participants in this experiment at present?
"Correct. According to clinicaltrials.gov, this study initiated on January 26th 2016 and was last updated in May 17th 2022 is currently recruiting 40 patients from 2 medical centres."
How many subjects are participating in this experiment?
"Affirmative. The clinical trial is still actively enrolling volunteers, as indicated by the information located on clinicaltrials.gov. It was initially listed on January 26th 2016 and has been recently updated on May 17th 2022; 40 participants are needed for this study at 2 sites."
Does this study encompass individuals beyond the age of thirty-five?
"This research project is looking to include participants aged 16 and up, but no older than 45."
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