Spina Bifida + MWFCC

In 2016, our center performed our first fetal repair of myelomeningocele (MMC), the most severe form of spina bifida. Led by a team of medical experts in the field of fetal diagnosis and therapy, our program has grown to become a high volume MMC fetal surgery center. As of January 2020, the Midwest Fetal Care Center has evaluated more than 52 women from across the Upper Midwest for fetal MMC repair; 37 of these patients met fetal surgery criteria, and 33 chose to undergo open fetal MMC repair.

Candidates evaluated for fMMC repair

  • Fetal MMC repair (%)
  • Not eligible (%)
  • Terminated (%)
  • Declined treatment (%)

Data table

Fetal MMC repair: 66%, Not eligible: 26%, Terminated: 6%, Declined treatment: 2%

fMMC patients by state of residence

  • MN (%)
  • IA (%)
  • ND (%)
  • SD (%)
  • WI (%)

Data table

MN: 64%, IA: 15%, ND: 9%, SD: 6%, WI: 6%

MOMS Trial

The Management of Myelomeningocele Study (MOMS trial)1, a 7-year, multi-center, randomized clinical research trial published in March 2011, was the first to comprehensively describe the outcomes of open fetal surgery for repair of spina bifida, compared to a traditional postnatal repair. The MOMS Trial included 183 surgically eligible patients, who were randomized to either fetal or postnatal MMC repair. Of those, 80 patients underwent post-birth surgical repair and 78 underwent open fetal surgery for spina bifida. Overall, the MOMS Trial concluded that prenatal surgery for myelomeningocele reduced the need for hydrocephalus-related neurosurgical interventions, including cerebrospinal shunt placement or endoscopic third ventriculostomy (ETV), and improved motor outcomes at 30 months versus postnatal repair, but was also associated with maternal and fetal risks. The MOMS Trial is seen as the industry benchmark for this treatment, and here we describe how our outcomes compare to those from this seminal study.

We participate in a multi-center collaborative registry, the international consortium and registry for spina bifda, hosted by the North American Fetal Therapy network (NAFTnet). Therefore, when a family provides permission (informed consent), we provide deidentified patient outcome information to the registry — along with other top fetal centers around the globe — in order to measure how we are doing and to improve patient care. Until more up-to-date outcomes are compiled from this global registry, we will continue to compare our outcomes data to the MOMS Trial.

Maternal characteristics of fMMC repair patients

31years

Average maternal age at surgery

24.8weeks

Average gestational age at surgery

Average maternal BMI category (kg/m2)
(Average: 31.0)

<35:70%
35-40:21%
>40:9%

Data table

<35: 70%, 35-40: 21%, >40: 9%

Outcomes after Fetal MMC Repair

71%
showed improved motor function
Outcome Metric MWFCC MOMS Trial
Surgical mgmt of hydrocephalus, 12 mo 7* of 17 (41%) 31 of 78 (40%)
Difference between motor function and anatomical levels†   (Age at pediatric function assessment is 12 mos for MWFCC and 30 mos for MOMS trial‡)
≥ Two levels better 8 of 17 (47%) 20 of 62 (32%)
One level better 4 of 17 (24%) 7 of 62 (11%)
No difference 3 of 17 (18%) 14 of 62 (23%)
One level worse 1 of 17 (6%) 13 of 62 (21%)
≥ Two levels worse 1 of 17 (6%) 8 of 62 (13%)

Data for 2/1/2016–11/30/2019

*Surgical management included shunt (n=5) or ETV (n=2)

†For the difference between the pediatric motor function level (12 month post-birth neurosurgery clinic assessment, average adjusted age at the time of the assessments=11.0±2.0 months) and the anatomical level (pre-birth ultrasound), “better” indicates function that is better than expected on the basis of the anatomical level

‡It is currently unknown if 12 month outcomes are consistent with 30 month outcomes

Maternal Outcomes and Delivery

To date, 33 mothers have elected to undergo open fetal repair of MMC at our center, with an average post-surgery length of stay of 5.0 days for the last 15 patients. Mothers are typically discharged home and further post-surgery care is comanaged with the mother’s referring maternal-fetal medicine specialist.

For the fetal repair patients, C-section deliveries are scheduled for approximately 36 weeks gestation at our center. The majority of patients spent less than a week in the hospital before delivery, and around three days in the hospital after delivery.

Our team makes every effort to minimize any potential maternal complications related to the fetal repair. For most of the conditions described, our center has had similar or slightly lower rates of complication as compared to the MOMS Trial.

Maternal Outcomes after Fetal MMC Repair*

Outcome Metric MWFCC MOMS Trial
Maternal survival 33 of 33 (100%) 78 of 78 (100%)
Membrane separation 6 of 30 (20%) 20 of 78 (26%)
Average gestational age at separation (weeks) 29.9 ± 1.9 Not reported
Abruption 1 of 30 (3%) 5 of 78 (6%)
Maternal transfusion at delivery 1 of 30 (3%) 7 of 78 (9%)
Dehiscence of hysterotomy at delivery 0 of 30 (0%) 8 of 76 (11%)

Data for 2/1/2016–1/24/2020 | Format: average ± standard deviation

*Of 33 fetal MMC repairs, 30 have given birth

Neonatal Outcomes

Of the 33 babies that have undergone open surgery for MMC at our center, 30 have been delivered, one died shortly after delivery from renal failure, and three have yet to be delivered as of January 2020.

Currently, pediatric outcomes data are available for a small subset of our patients through 12 months.

Hydrocephalus, or brain swelling, can occur in babies with spina bifida and is typically treated by diverting cerebrospinal fluid using a surgical procedure (endoscopic third ventriculostomy, ETV) or by permanently placed brain shunt. For more information on hydrocephalus, ETV and shunt procedures, please refer to Children’s Minnesota’s neurosurgery page.

The MOMS Trial showed important benefits to infants that underwent fetal repairs, including a reduction in the need for shunt/ETV from 82% (postnatal repair) to 40% during the first 12 months of life. Overall, the patient data from our center is similar to the outcomes reported in the MOMS Trial, with a 41% rate of surgical management of hydrocephalus. In addition, more than 70% of our fetal MMC repair patients showed an improvement in motor function at their 12 month follow-up appointment, compared to the function predicted by their prenatal ultrasound reading (prior to MMC repair).

Urinary, bladder, and bowel dysfunction may occur in babies with spina bifida due to the nerve damage caused in utero. A MOMS Trial companion paper found that at 30 months, the fetal MMC repair group had a clean intermittent catheterization (CIC) rate of 38%2. The data currently available for our center shows a 19% CIC rate at 12 months (3/16 patients). Reoccurring urinary tract infections (UTIs) occurred in 6% (1/16) of our fetal repair patients, and constipation in 50% (8/16).

References:
1 Adzick NS, Thom EA, Spong CY, et al. A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele. New England Journal of Medicine. 2011;364(11):993-1004.
2 Brock JW, Carr MC, Adzick NS, Burrows PK, Thomas JC, Thom EA, Howell LJ, Farrell JA, Dabrowiak ME, Farmer DL, Cheng EY. Bladder function after fetal surgery for myelomeningocele. Pediatrics. 2015;136(4):e906-13.

Neonatal Outcomes after Fetal MMC Repair

Outcome Metric MWFCC MOMS Trial
Neonatal survival to delivery* 30 of 30 (100%) 77 of 78 (99%)
Neonatal survival post-delivery 29 of 30 (97%) 76 of 77 (99%)
Average GA at delivery (weeks) 33.7 ± 3.1 34.1 ± 3.1
Average Birthweight, g 2178 ± 643 2383 ± 688
Apnea† 10 of 29 (34%) 28 of 77 (36%)
Respiratory Distress Syndrome 5 of 29 (17%) 16 of 77 (21%)
Foot deformity 10 of 29 (34%) 8 of 78 (50%)

Data for 2/1/2016–1/24/2020 | Format: average ± standard deviation

*Perinatal survival: 98% (n=2) in the MOMS Trial postnatal repair group1

†Definition: true cessation of breathing during rest that results in the need for caffeine due to apnea-based symptoms (not given prophylactically) or home-monitor at NICU discharge

Surgical management of hydrocephalus at 12 months post-fMMC repair

59%
required no surgical intervention
  • No intervention (%)
  • Surgical management (%)

Data table

No intervention: 59%, Surgical management: 41%

Our goal is to provide our patients and community the latest patient outcomes data to support informed decision making. We encourage you to reach out to other health care systems to request and review their outcomes data in order to utilize the information available when evaluating your health care options.

CONTACT US

Appointments & Referrals
855-693-3825
(855-MW-FETAL)