RECRUITING

Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

Conditions

Neural Tube Defects Spina Bifida Myelomeningocele Chiari Malformation neural tube defect fetoscopy percutaneous fetus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Official Title

In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study

Quick Facts

Study Start:2018-11-02

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03856034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography. 2. Maternal age ≥18 years. 3. Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound. 4. Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more. 5. Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study. 6. Positive evaluation from pediatric neurology consult. 7. Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.	1. Multiple gestation 2. Insulin-dependent pregestational diabetes 3. Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded. 4. Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI. 5. Presence of uterine cervical cerclage or history of incompetent cervix. 6. Placenta previa or placental abruption. 7. Short cervix \< 25 mm measured by cervical ultrasound. 8. Obesity as defined by body mass index (BMI) of 35 or greater. 9. History of previous spontaneous singleton delivery prior to 37 weeks. 10. Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia. 11. Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled. 12. Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened. 13. Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality. 14. Other maternal medical condition which is a contraindication to surgery or anesthesia. 15. Patient does not have a support person (e.g., husband, partner, parents). 16. Inability to comply with the travel and follow-up requirements of the study. 17. Patient does not meet psychosocial criteria as determined by the social worker evaluation. 18. Participation in another intervention study that influences maternal and fetal morbidity and mortality. 19. Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy). 20. Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery. 21. Nickel allergy. 22. Maternal request to undergo open fetal surgery for the antenatal correction of open spina bifida at our institution primarily or after failed fetoscopic approach. 23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.

Inclusion Criteria

Exclusion Criteria

1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
2. Maternal age ≥18 years.
3. Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
4. Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
5. Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
6. Positive evaluation from pediatric neurology consult.
7. Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.

1. Multiple gestation
2. Insulin-dependent pregestational diabetes
3. Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
4. Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
5. Presence of uterine cervical cerclage or history of incompetent cervix.
6. Placenta previa or placental abruption.
7. Short cervix \< 25 mm measured by cervical ultrasound.
8. Obesity as defined by body mass index (BMI) of 35 or greater.
9. History of previous spontaneous singleton delivery prior to 37 weeks.
10. Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
11. Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
12. Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
13. Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
14. Other maternal medical condition which is a contraindication to surgery or anesthesia.
15. Patient does not have a support person (e.g., husband, partner, parents).
16. Inability to comply with the travel and follow-up requirements of the study.
17. Patient does not meet psychosocial criteria as determined by the social worker evaluation.
18. Participation in another intervention study that influences maternal and fetal morbidity and mortality.
19. Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
20. Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
21. Nickel allergy.
22. Maternal request to undergo open fetal surgery for the antenatal correction of open spina bifida at our institution primarily or after failed fetoscopic approach.
23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.

Contacts and Locations

Study Contact

Ruben Quintero, MD

CONTACT

720-753-3825

q@the-fetal-institute.com

Ramen Chmait, MD

CONTACT

626-356-3360

chmait@usc.edu

Principal Investigator

Ruben Quintero, MD

PRINCIPAL_INVESTIGATOR

Wellington Regional Medical Center

Ramen Chmait, MD

PRINCIPAL_INVESTIGATOR

University of Southern California/ Huntington Memorial Hospital

Study Locations (Sites)

University of Southern California / Huntington Memorial Hospital

Los Angeles, California, 91105

United States

Wellington Regional Medical Center

Wellington, Florida, 33141

United States

Collaborators and Investigators

Sponsor: USFetus

Ruben Quintero, MD, PRINCIPAL_INVESTIGATOR, Wellington Regional Medical Center
Ramen Chmait, MD, PRINCIPAL_INVESTIGATOR, University of Southern California/ Huntington Memorial Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-02

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2018-11-02

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

spina bifida
myelomeningocele
neural tube defect
chiari malformation
fetoscopy
percutaneous
fetus

Additional Relevant MeSH Terms

Neural Tube Defects
Spina Bifida
Myelomeningocele
Chiari Malformation