A Registry to Follow Long-Term Outcomes for Mother and Child Pairs After Fetal Surgery for Spina Bifida

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-009015
    Sponsor Protocol Number: 14-009015

About this study

The purpose of this study is to form a registry of data on the long term physical and mental health outcomes of the mother and child following fetal surgical repair for spina bifida.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Any woman undergoing evaluation for maternal-fetal surgery for myelomeningocele will be included for screening
  • If eligible and has the surgery after 12/15/2010, information from surgery will be collected 
  • Informed consent to collect this information will be done at their surgical evaluation visit
  • If not able to be consented at this visit, they will be called and consented verbally

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nicholas Wetjen, M.D.

Open for enrollment

Contact information:

Debra Rundquist R.N.

(507)538-0127

rundquist.debra2@mayo.edu

.
CLS-20164768

Mayo Clinic Footer