In Utero Procedure Affecting Fetus or Newborn
Conditions
Brief summary
The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery
Detailed description
Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes
Interventions
DEVICEKARL STORZ fetoscope arm
The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant woman * The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition * Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure
Exclusion criteria
* Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia * Allergy or previous adverse reaction to a study medication specified in this protocol * Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy * Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation * Suspicion of a major recognized syndrome by ultrasound or MRI * Maternal BMI \>40 kg/m2 * High risk for fetal hemophilia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gestational age at delivery in patients requiring percutaneous in-utero surgery | at time of delivery (about 10 weeks after in utero surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved visualization as assessed by the Likert scale | within 24 hours of in utero surgery | This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes. |
| Improved angle for laser visualization as assessed by the Likert scale | within 24 hours of in utero surgery | This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree |
| Improved ease of use of the new fetoscope as assessed by a questionnaire | within 24 hours of in utero surgery | This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome |
| Operative time in minutes | end of surgery ( about 1 hour form start of surgery) | Time from from operative cannula insertion until it is removed |
| Number of fetuses alive prior to hospital discharge | time of discharge (about 48 hours after surgery) | — |
| Number of successful procedures with completion of laser ablation of the abnormal vessels. | within 24 hours of in utero surgery | — |
| Total number of patients that have maternal and/or fetal perioperative complications | from end of surgery to within 10 weeks after surgery | — |
| The number of participants that develop twin-anemia-polycythemia sequence (TAPS) | from end of surgery to within 10 weeks after surgery | — |
| Total number of live births | from time of in utero surgery till delivery (about 10 weeks after surgery) | — |
| Total number of short-term morbidities | from time of in utero surgery till delivery (about 10 weeks after surgery) | Short-term morbidities include, but are not limited to, premature delivery (\<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis. |
| Total number of maternal patients that present with short term morbidity | from end of surgery to within 10 weeks after surgery | Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption |
Countries
United States
Contacts
Primary ContactJimmy Espinoza, MD, MSc,FACOG
Backup ContactElisa Garcia
Outcome results
None listed