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Procedure

In-Utero Surgery Techniques for Spina Bifida

N/A

Recruiting

Led By Ruben Quintero, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal age ≥18 years

Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation confirmed by MRI and ultrasonography

Must not have

Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality

Presence of a fetal anomaly not related to Chiari II Malformation. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial will study two ways to fix spina bifida in fetuses. One is done by going through the skin and the other is by opening the belly and taking the uterus out.

Who is the study for?

This trial is for pregnant women over 18 with a fetus diagnosed with spina bifida (T1-S1 level) and hindbrain herniation, between 19-27 weeks' gestation. Candidates must have normal genetic test results, be able to consent and follow the study plan, and have support systems in place. Exclusions include multiple pregnancies, certain maternal health issues like diabetes or obesity (BMI ≥40), previous early deliveries, positive HIV/Hepatitis-B status or other conditions that risk surgery/anesthesia.

What is being tested?

The trial tests two surgical methods to correct fetal spina bifida before birth: one through small incisions using cameras (percutaneous technique) and another by opening the abdomen to access the uterus directly (laparotomy/uterine exteriorization). The goal is to see which method might be safer or more effective.

What are the potential side effects?

Potential side effects could include complications from anesthesia, risks of preterm labor or delivery due to uterine surgery, infection risks for both mother and baby, possible harm to the fetus during surgery including bleeding or trauma, and postoperative issues such as scarring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a spinal defect from T1 to S1 with brain tissue protrusion, confirmed by MRI and ultrasound.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a large fibroid or multiple fibroids, or an abnormality in my uterus.

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My unborn baby has a condition not related to Chiari II Malformation.

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I have a cervical stitch or a history of weak cervix.

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I do not have HIV or Hepatitis B, or I have tested negative for both.

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I have a health condition that makes surgery or anesthesia unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ability to perform the endoscopic procedure

Secondary study objectives

Chiari II malformation reversal

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Percutaneous TechniqueExperimental Treatment1 Intervention

The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery. A variation of the percutaneous technique is the mini-laparotomy technique, which uses an endoscopic scope through an incision on the abdomen, smaller than a laparotomy ("mini-laparotomy"), and smaller endoscopic scopes through the maternal skin and uterus to perform the surgery.

Group II: Laparotomy/Uterine Exteriorization TechniqueExperimental Treatment1 Intervention

The laparotomy/uterine exteriorization technique consists of performing a laparotomy (incision into the abdominal cavity), exteriorizing the uterus, and using endoscopic scopes through the uterus to perform the correction.

0 / 7Eligibility criteria met