Fetoscopic repair of neural tube defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the outcomes of fetoscopic repair for neural tube defects, specifically spina bifida, at Oregon Health & Science University. Patients will undergo the procedure between 24 and 27 weeks of gestation, with various surgical approaches determined by individual circumstances. The study will collect data on surgical, post-operative, delivery, and neonatal outcomes, as well as follow-up evaluations throughout childhood.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Maternal age 18 years or older
* Capable of consenting for their own participation in the study
* Decision to have fetoscopic repair following counseling of all options
* Open spina bifida with the upper boundary between T1 and S1
* Gestational age between 24 0/7 to 26 6/7 weeks' gestation at the time of surgery
* Normal karyotype and/or normal chromosomal microarray by invasive testing. In the case of a microdeletion, microduplication, or variant of uncertain significant, the decision to include or exclude will be at the discretion of the Principal Investigators.
* Absence of major cardiac anomalies confirmed by fetal echocardiogram
* Adequate social support throughout pregnancy
* Parental or guardian willingness to undergo follow-up evaluations of the child after birth

Exclusion Criteria:

* Multiple gestation
* Major fetal anomalies unrelated to the neural tube defect
* Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI
* Previous spontaneous singleton preterm birth prior to 37 weeks
* Presence of cervical cerclage at the time of surgery or history of cervical insufficiency
* Cervical length less than 20 mm by endovaginal ultrasound
* Placenta previa or evidence of placental abruption
* Technical factors such as large uterine fibroids, uterine anomalies, or fetal membrane separation for which the risks of surgery are deemed to outweigh the benefits
* Maternal obesity precluding surgical access with a BMI \> 45 or if the Principal Investigator determines the body habitus to be technically challenging
* Alloimmunization in pregnancy including Kell sensitization or a history of neonatal alloimmune thrombocytopenia
* Maternal HIV or Hepatitis B positive status. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to be negative prior to surgery
* Known Hepatitis C positivity. If the patient's Hepatitis C status is known, they do not need to be screened
* Maternal medical condition which is a contraindication to surgery or general anesthesia. This includes previous hysterotomy in the active segment of the uterus
* Maternal medical co-morbidities which would significantly increase the risk of spontaneous or iatrogenic preterm delivery
* Inability of the patient to comply with travel and follow-up requirements of the study
* Patient not meeting psychosocial criteria determined by fetal care social worked to comply with the medical care and plan for follow ups
* Participation in another interventional study that influences maternal and fetal morbidity and mortality
* Known history of hypersensitivity to collagen products or chondroitin materials

Where it's running

• Oregon Health & Science University
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Raphael Sun, MD — Oregon Health and Science University
• Study coordinator: Women's Health Research Unit Department of Ob/Gyn
• Email: whru@ohsu.edu
• Phone: 503-494-3666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.