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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Operative time in minutes
Time from from operative cannula insertion until it is removed
Time frame: during surgery
Number of Participants that have a gestational age of less than 37 weeks
Time frame: at time of delivery (about 20 weeks from surgery)
Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention
Time frame: end of surgery (about 60 minutes after start of surgery)
Total number of procedures with completion of the laser ablation
Time frame: end of surgery (about 60 minutes after start of 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.
Time frame: end of surgery (about 60 minutes after start of 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
Time frame: end of surgery (about 60 minutes after start of surgery)
Total number of fetuses alive, after the laser photocoagulation procedure
Time frame: at discharge from hospital (about 24 hours after surgery)
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Total number of maternal patients that present with morbidity
Time frame: at discharge from hospital (about 24 hours after surgery)
Total number of patients that have maternal and/or fetal perioperative complications
Time frame: end of surgery (about 60 minutes after start of surgery)
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
Time frame: end of surgery (about 60 minutes after start of surgery)
Number of live births
Time frame: at time of delivery (about 20 weeks from surgery)
Number of neonates with a short-term morbidity
Time frame: from birth until hospital discharge
Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)
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
Time frame: 24 months of age