Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03856034|
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : November 13, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Neural Tube Defects Spina Bifida Myelomeningocele Chiari Malformation||Device: Fetoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study|
|Actual Study Start Date :||November 2, 2018|
|Estimated Primary Completion Date :||November 2, 2020|
|Estimated Study Completion Date :||December 31, 2027|
|Experimental: Fetoscopic repair||
Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).
- Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques [ Time Frame: At time of surgery until delivery, up to 21 weeks ]Successful fetoscopic closure of the spinal defect and reversal of hindbrain herniation as assessed by ultrasound and MRI prior to delivery
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
- Maternal age ≥18 years.
- Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
- 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.
- 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.
- Positive evaluation from pediatric neurology consult.
- 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.
- Multiple gestation
- Insulin-dependent pregestational diabetes
- 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.
- Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
- Presence of uterine cervical cerclage or history of incompetent cervix.
- Placenta previa or placental abruption.
- Short cervix < 25 mm measured by cervical ultrasound.
- Obesity as defined by body mass index (BMI) of 35 or greater.
- History of previous spontaneous singleton delivery prior to 37 weeks.
- Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
- 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.
- Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
- Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
- Other maternal medical condition which is a contraindication to surgery or anesthesia.
- Patient does not have a support person (e.g., husband, partner, parents).
- Inability to comply with the travel and follow-up requirements of the study.
- Patient does not meet psychosocial criteria as determined by the social worker evaluation.
- Participation in another intervention study that influences maternal and fetal morbidity and mortality.
- 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).
- Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
- Nickel allergy.
- Maternal request to undergo open fetal surgery for the antenatal correction of open spina bifida at our institution primarily or after failed fetoscopic approach.
- Known maternal hypersensitivity to bovine collagen or chondroitin materials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856034
|Contact: Ruben Quintero, MDfirstname.lastname@example.org|
|Contact: Ramen Chmait, MDemail@example.com|
|United States, California|
|University of Southern California / Huntington Memorial Hospital||Recruiting|
|Los Angeles, California, United States, 91105|
|Contact: Ramen Chmait, MD 626-356-3360 firstname.lastname@example.org|
|Contact: Arlyn Llanes, RN 626-356-3360 email@example.com|
|United States, Florida|
|Wellington Regional Medical Center||Recruiting|
|Wellington, Florida, United States, 33141|
|Contact: Ruben Quintero, MD 720-753-3825 firstname.lastname@example.org|
|Contact: Eftichia Kontopoulos, MD 720-753-3825 email@example.com|
|Principal Investigator:||Ruben Quintero, MD||Wellington Regional Medical Center|
|Principal Investigator:||Ramen Chmait, MD||University of Southern California/ Huntington Memorial Hospital|
|Other Study ID Numbers:||
|First Posted:||February 27, 2019 Key Record Dates|
|Last Update Posted:||November 13, 2019|
|Last Verified:||November 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
neural tube defect
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases