Open Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 And 40.0
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Complications associated with obesity during pregnancy.
研究概览
简要总结
Spina bifida is a neurological abnormality characterized by an opening in the skin and exposure of the spinal cord on the back of the baby at the time of birth. The complete closure and separation of the spinal cord from the skin occurs in the first month of pregnancy.
This form of spina bifida is associated with leg weakness, sensation loss, and bowel and bladder incontinence. The majority of patients (>80%) also develop increased fluid in the brain, called hydrocephalus, and require additional surgery to treat this problem. Standard treatment of myelomeningocele (MMC) involves closing the opening in the back within the first 3 days of life. The surgery releases the spinal cord from the skin and brings the skin edges together to prevent infection and injury to the exposed nerves. Of note, this type of surgery does not improve function.
The investigators want to study the open in-utero fetal surgery technique in patients who are candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of 35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the United States.
详细描述
The research will be conducted at the following location(s):
Baylor College of Medicine and Texas Children's Hospital- Women's Pavilion.
About 15 subjects will be enrolled in this study. In order to be eligible for this study, the participant must meet the established criteria for open fetal MMC surgery but also have a BMI of 35.0-40.0.
PREOPERATIVE AND INTRAOPERATIVE CONCOMITANT MEDICATIONS:
The participant will receive two doses of 12 mg betamethasone, 24 hours apart, for fetal lung maturation if the gestational age is greater than 23 weeks. The participant will also receive the prophylactic tocolysis (medications to prevent preterm contractions) indomethacin 50 mg prior to surgery, then 25-50 mg every six to eight hours for 24-48 hours following the surgery, longer if clinically indicated. Magnesium sulfate may also be used intraoperatively - 6 gram IV loading dose followed by a 2 gram/hour continuous infusion for 24 - 72 hours. In addition, if medically indicated, nifedipine (10mg orally) or terbutaline (0.25mg subcuticularly) may be substituted for the indomethacin or magnesium sulfate based on condition and medical judgment. Prophylactic antibiotics will also be administered to the participant prior to the procedure using cefazolin, azithromycin, and/or metronidazole, or if medical history contraindicates the use of cefazolin, clindamycin,azithromycin, and gentamicin will be administered. A solution of nafcillin and lactated ringers will be injected into the amniotic cavity at the conclusion of the procedure. Additional medications, including therapeutic antibiotics, may be used as part of standard of care by the medical team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
- •Parental/guardian permission (informed consent) for follow up of child after birth.
排除标准
- •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 ≥35
- •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, uterine anomalies incompatible with fetoscopy.
- •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 (ie. 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
- •Patient scores as severely depressed on the BDI-II questionnaire; a score of 29 or above.
研究组 & 干预措施
Open-Uterus Fetal Repair
Single arm study. All patients will receive the open-uterus fetal repair.
干预措施: Open-Uterus Fetal Repair (Procedure)
结局指标
主要结局
Complications associated with obesity during pregnancy.
时间窗: During the post-surgical course of pregnancy.
Determine if there is an increased risk for mothers with a BMI of 35-40 after having undergone an open in-utero surgical repair for myelomeningocele.
Complications associated with obesity during Surgery.
时间窗: At the time of fetal repair surgery.
Determine if there is an increased risk for mothers with a BMI of 35-40 during an open in-utero surgical repair for myelomeningocele.
次要结局
未报告次要终点
研究者
Michael Belfort
Professor and Chairman, Department of Obstetrics and Gynecology
Baylor College of Medicine