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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
Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KARL STORZ fetoscope arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KARL STORZ fetoscope arm | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at delivery in patients requiring percutaneous in-utero surgery | at time of delivery (about 10 weeks after in utero surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful procedures with completion of laser ablation of the abnormal vessels. | within 24 hours of in utero surgery | |
| Improved visualization as assessed by the Likert scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jimmy Espinoza, MD, MSc,FACOG | Contact | (713) 500-5859 | Jimmy.Espinoza@uth.tmc.edu | |
| Elisa Garcia | Contact | 713-500-6347 | Elisa.I.Garcia@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jimmy Espinoza, MD, MSc,FACOG | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| within 24 hours of in utero surgery |
| Improved angle for laser visualization as assessed by the Likert scale | This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree | within 24 hours of in utero surgery |
| Improved ease of use of the new fetoscope as assessed by a questionnaire | 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 | within 24 hours of in utero surgery |
| Operative time in minutes | Time from from operative cannula insertion until it is removed | end of surgery ( about 1 hour form start of surgery) |
| Number of fetuses alive prior to hospital discharge | time of discharge (about 48 hours after surgery) |
| Total number of maternal patients that present with short term morbidity | Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption | from end of surgery to within 10 weeks after 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 | 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. | from time of in utero surgery till delivery (about 10 weeks after surgery) |