Recruiting

Fetoscopic Repair

Sponsor:

Oregon Health and Science University

Code:

NCT06946563

Conditions

Neural Tube Defects

Spina Bifida

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fetoscopic Neural Tube Defect Repair Devices

Study Details

Brief summary:

This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.

Conditions

Neural Tube Defects

Spina Bifida

Study ID

NCT06946563

Start date

Apr 1, 2023

Status verified date

Apr, 2025

Completion date

Apr, 2033

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Fetoscopic Neural Tube Defect Repair

Individuals who undergo fetoscopic Neural Tube Defect (NTD) repair. Participants will undergo fetal surgery between 24 weeks 0 days and 27 weeks 6 days.

Interventions

Fetoscopic Neural Tube Defect Repair Devices

Fetoscopic NTD repair will be performed on enrolled participants. An incision will be made to gain exposure and access to the uterus. The amniotic cavity is entered using a needle to administer fetal anesthesia. Then, the initial trocar is inserted into the amniotic cavity. The major steps of the procedure are neural placode dissection, myofascial flaps creation, and closure of the neural tube defect.

Primary outcome measure

  • Feasibility of minimally invasive surgical repair of NTD in fetus [ Time Frame: At the time of NTD repair surgery ]

Central Contacts and Locations

Central contacts

Women's Health Research Unit Department of Ob/Gyn

503-494-3666whru@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Women's Health Research Unit

503-494-3666whru@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 27, 2025

Last verified

Apr, 2025

Keywords

  • Fetal Surgery
  • Fetoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-04-27.