Twin to Twin Transfusion Syndrome
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for laser photocoagulation of placental anastomoses in patients with an anterior placenta and Twin to Twin Transfusion Syndrome (TTTS).
Interventions
DEVICECurved KARL STORZ fetoscope
The KARLZ STORZ curved scope is used to see the inside of a pregnant person's uterus during minimally invasive surgery, similar to conventional scopes. The curved scope is rounded and thought to help visualize the anterior placenta because of its position on the uterus.
DEVICEConventional Scopes
The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.
Sponsors
Jimmy Espinoza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* pregnancy * The patient fulfills the criteria for laser photocoagulation of placental anastomoses based on the standard of care * fetal diagnosis of twin-to-twin transfusion syndrome * Anterior placenta * The patient 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 * The patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery * 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 | Description |
|---|---|---|
| Operative time in minutes | during surgery | Time from from operative cannula insertion until it is removed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of maternal patients that present with morbidity | at discharge from hospital (about 24 hours after surgery) | — |
| Total number of patients that have maternal and/or fetal perioperative complications | end of surgery (about 60 minutes after start of surgery) | — |
| The number of participants that develop twin-anemia-polycythemia sequence (TAPS) | end of surgery (about 60 minutes after start of surgery) | — |
| Number of live births | at time of delivery (about 20 weeks from surgery) | — |
| Number of neonates with a short-term morbidity | from birth until hospital discharge | — |
| Total number of fetuses alive, after the laser photocoagulation procedure | at discharge from hospital (about 24 hours after surgery) | — |
| Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention | end of surgery (about 60 minutes after start of surgery) | — |
| Total number of procedures with completion of the laser ablation | end of surgery (about 60 minutes after start of surgery) | — |
| Improved visualization as assessed by the Likert scale | end of surgery (about 60 minutes after start of 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 | end of surgery (about 60 minutes after start of surgery) | This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree |
| Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3) | 24 months of age | Scored items on ASQ-3 address 5 areas of child development: communication, gross motor, Fine motor, problem solving, and personal-social and each of these have 6 questions each and is scored as yes( 10 points), sometimes (5 points) and not yet (0 points)-the total score is calculated for each area and scores should fall between 0-60, and a higher score indicates more development. There is a 9 item overall developmental section that is answered categorically as yes or no answer |
| Number of Participants that have a gestational age of less than 37 weeks | at time of delivery (about 20 weeks from surgery) | — |
Countries
United States
Contacts
Primary ContactJimmy Espinoza, MD, MSc,FACOG
Backup ContactElisa Garcia
Outcome results
None listed