Fetoscopic Meningomyelocele Repair Study (fMMC)
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|ClinicalTrials.gov Identifier: NCT02230072|
Recruitment Status : Active, not recruiting
First Posted : September 3, 2014
Last Update Posted : March 29, 2023
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The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.
The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the same efficacy as open fetal surgery for MMC, but with significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery. The fetus will have a repaired MMC defect, and the mother will not have a uterine incision (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if the baby is shown to have a skin covered repair.
|Condition or disease||Intervention/treatment||Phase|
|Neural Tube Defect||Device: fetoscopy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimally Invasive Fetal Neural Tube Defect Repair Study|
|Actual Study Start Date :||July 2014|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
Experimental: fetoscopic surgical repair
Single arm study. All patients will receive the fetoscopic repair.
The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the fetal open neural tube defect.
- Feasibility [ Time Frame: Time of procedure ]Whether the minimally invasive technique can be technically performed in human patients (success of primary skin closure) in a safe and effective manner.
- Reversal of the Chiari II malformation with complete closure of the spinal defect. [ Time Frame: at birth ]Whether the minimally invasive technique results in an acceptable fetal outcome as defined by reversal of the Chiari II malformation, a reduced need for ventriculoperitoneal shunting or other procedures to avoid or treat hydrocephalus, and complete closure of the spinal defect with protection of the placode. In addition the procedure will be assessed as to whether it prevents loss of neurological level during intra-uterine life.
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|Ages Eligible for Study:||18 Years to 64 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Pregnant women - maternal age 18 years or older and capable of consenting for their own participation in this study,
- Singleton pregnancy,
- MMC with the upper boundary located between T1 and S1,
- Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation),
- Absence of chromosomal abnormalities and associated anomalies,
- Gestational age at the time of the procedure will be between 19 0/7 weeks and 25 6/7 weeks,
- Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or CVS). If there is a balanced translocation with normal MCA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded.
- Family has considered and declined the option of termination of the pregnancy at less than 24 weeks,
- Family meets psychosocial criteria (sufficient social support, ability to understand requirements of the study), and
- Parental/guardian permission (informed consent) for follow up of child after birth.
- Fetal anomaly unrelated to MMC,
- Severe kyphosis,
- Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth,
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment,
- A pre-pregnancy body-mass index ≥40,
- Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment,
- Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, and uterine anomalies,
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy,
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment,
- Maternal medical condition that is a contraindication to surgery or anesthesia,
- Low amniotic fluid volume (Amniotic Fluid Index less than 6cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion,
- Patient does not have a support person (e.g. Spouse, partner, mother) available to support the patient for the duration of the pregnancy,
- Inability to comply with the travel and follow-up requirements of the trial,
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy, and
- Patient scores as severely depressed on the BDI-II questionnaire; a score of 29 or above.
- Maternal hypersensitivity to collagen.
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): NCT02230072
|United States, California|
|Stanford University: Lucille Packard's Childrens Hospital|
|Stanford, California, United States, 94305|
|United States, Texas|
|Texas Childrens Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael A. Belfort, M.D.||Baylor College of Medicine|
|Responsible Party:||Michael A Belfort, Professor and Chairman, Department of Obstetrics and Gynecology, Baylor College of Medicine|
|Other Study ID Numbers:||
|First Posted:||September 3, 2014 Key Record Dates|
|Last Update Posted:||March 29, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
Neural Tube Defect
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases