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Journal of Perinatal Medicine Jun 2024Fetoscopic laser coagulation of placental anastomoses is usually performed for a treatment of twin-to-twin transfusion syndrome (TTTS). A common complication of... (Comparative Study)
Comparative Study
Fetoscopic laser coagulation for twin-to-twin transfusion syndrome: a comparison of flexible 1.0/1.2 mm fetoscopes with curved sheaths of 2.7/3.3 mm vs. 2 mm fetoscopic lens technique with sheaths of 6.6/11.3 mm.
OBJECTIVES
Fetoscopic laser coagulation of placental anastomoses is usually performed for a treatment of twin-to-twin transfusion syndrome (TTTS). A common complication of fetoscopic laser coagulation for TTTS is preterm preliminary rupture of fetal membranes (PPROM) aggravating the neonatal outcome significantly. However, use of an flexible 1 mm fetoscope with an curved sheath could reduce iatrogenic damage of the amniotic membrane and improve neonatal outcomes after laser treatment. The aim of this study was to compare neonatal outcomes using this flexible fetoscope with curved sheath vs. use of a standard lens technique.
METHODS
Outcomes were retrospective analyzed after use of a standard lens fetoscope of 2 mm (sheath 6.63 mm or 11.27 mm for anterior placenta) and a flexible fetoscope of 1 mm or 1.2 mm (sheath 2.65 mm or 3.34 mm) in two German centers of fetal surgery, performed during 2006-2019.
RESULTS
Neonatal outcome of 247 TTTS patients were analyzed including the rates of double and single fetal survival. The survival of at least one fetus was 97.2 % in the group with the ultrathin technique (n=154) compared to 88.3 % (n=93) in the group with the standard lens fetoscope (p=0.008). Survival of both fetuses was not different between groups (81.0 vs. 75.3 %). The procedure to delivery interval was significantly increased using the ultrathin fetoscope (89.1±35.0 d vs. 71.4±35.4 d, p=0.001) resulting in an increased gestational age at delivery by 11 days on average (231.9±28.1 d vs. 221.1±32.7 d, p=0.012).
CONCLUSIONS
Fetal survival can be significantly increased following TTTS using flexible fetoscope of 1 mm or 1.2 mm (sheath 2.65 mm or 3.34 mm).
Topics: Humans; Fetofetal Transfusion; Pregnancy; Female; Fetoscopy; Retrospective Studies; Laser Coagulation; Fetoscopes; Adult; Infant, Newborn; Fetal Membranes, Premature Rupture
PubMed: 38536953
DOI: 10.1515/jpm-2023-0328 -
Artificial Intelligence in Medicine Jan 2024Fetoscopic Laser Coagulation (FLC) for Twin to Twin Transfusion Syndrome is a challenging intervention due to the working conditions: low quality images acquired from a...
Fetoscopic Laser Coagulation (FLC) for Twin to Twin Transfusion Syndrome is a challenging intervention due to the working conditions: low quality images acquired from a 3 mm fetoscope inside a turbid liquid environment, local view of the placental surface, unstable surgical field and delicate tissue layers. FLC is based on locating, coagulating and reviewing anastomoses over the placenta's surface. The procedure demands the surgeons to generate a mental map of the placenta with the distribution of the anastomoses, maintaining, at the same time, precision in coagulation and protecting the placenta and amniotic sac from potential damages. This paper describes a teleoperated platform with a cognitive-based control that provides assistance to improve patient safety and surgery performance during fetoscope navigation, target re-location and coagulation processes. A comparative study between manual and teleoperated operation, executed in dry laboratory conditions, analyzes basic fetoscopic skills: fetoscope navigation and laser coagulation. Two exercises are proposed: first, fetoscope guidance and precise coagulation. Second, a resolved placenta (all anastomoses are indicated) to evaluate navigation, re-location and coagulation. The results are analyzed in terms of economy of movement, execution time, coagulation accuracy, amount of coagulated placental surface and risk of placenta puncture. In addition, new metrics, based on navigation and coagulation maps evaluate robotic performance. The results validate the developed platform, showing noticeable improvements in all the metrics.
Topics: Female; Pregnancy; Humans; Laser Coagulation; Fetoscopes; Robotics; Placenta; Exercise
PubMed: 38184348
DOI: 10.1016/j.artmed.2023.102725 -
American Journal of Obstetrics &... May 2022Preterm prelabor rupture of membranes is the most frequent complication of fetoscopic surgery. Strategies to seal the membrane defect created by fetoscopy have been...
BACKGROUND
Preterm prelabor rupture of membranes is the most frequent complication of fetoscopic surgery. Strategies to seal the membrane defect created by fetoscopy have been attempted with little success. We previously developed an integrated semirigid bioadhesive patch composed of silicone and hydroxypropyl methylcellulose that achieved ex vivo sealing of membrane defects.
OBJECTIVE
To evaluate the feasibility of the insertion of our integrated semirigid bioadhesive patches using a fetoscopic technique and to test the adhesion in ex vivo human membranes and in an in vivo ovine model.
STUDY DESIGN
An experimental study involving 2 experiments: (1) ex vivo-human fetal membranes were mounted in a custom-designed model with saline solution simulating intraamniotic pressure. The insertion of 2 different bioadhesive patches made of silicone-hydroxypropyl methylcellulose and silicone-polyurethane-hydroxypropyl methylcellulose was performed through a 12-Fr cannula mimicking fetoscopic surgery technique. The experiment was repeated 10 times with membranes from different donors. Measures included insertion time, successful insertion, and adhesion at 5 minutes; (2) in vivo-16 patches of silicone-hydroxypropyl methylcellulose were inserted by fetoscopy in the amniotic cavity of pregnant sheep (4 bioadhesives per animal, in 4 ewes). Measures included successful insertion, adhesion at 5 minutes, and adhesion at the end of surgery.
RESULTS
In the ex vivo insertion study, there was no difference in the insertion time between silicone-hydroxypropyl methylcellulose and silicone-polyurethane-hydroxypropyl methylcellulose patches (P=.49). Insertion was successful in all cases, but complete adhesion at 5 minutes was superior for silicone-hydroxypropyl methylcellulose (P=.02). In the in vivo study, insertion of silicone-hydroxypropyl methylcellulose by fetoscopy was feasible and successful in all cases, and no complications were reported. Adhesion persisted at 5 minutes and at the end of the surgery in 68.8% and 56.3% of the patches, respectively.
CONCLUSION
We describe the feasibility of deploying through a fetoscopic trocar a semirigid silicone-hydroxypropyl methylcellulose patch that seals fetal membranes after an invasive fetal procedure. The results warrant further research for improving long-term adhesion and developing a clinically applicable system.
Topics: Animals; Female; Fetoscopes; Fetoscopy; Hypromellose Derivatives; Polyurethanes; Pregnancy; Sheep; Silicones
PubMed: 35144009
DOI: 10.1016/j.ajogmf.2022.100593 -
Medical Devices (Auckland, N.Z.) 2020The annual global neonatal mortality stands at 2.5 million deaths, 1 million of them dying within the first day of life. An additional 2.6 million are stillborn...
BACKGROUND
The annual global neonatal mortality stands at 2.5 million deaths, 1 million of them dying within the first day of life. An additional 2.6 million are stillborn globally, the majority of them due to intrapartum events. Optimal fetal heart rate (FHR) monitoring has the potential to timely detect fetuses at risk and, if coupled with timely obstetric responses may save more newborns. Moyo is a new Doppler with nine crystals capable of monitoring FHR both intermittently and continuously.
AIM
To assess women's and midwives' opinions on the use of Moyo for intrapartum FHR monitoring.
METHODS
We conducted a cross-sectional study using a structured questionnaire to assess women's and midwives' perception. Women who gave birth at the hospital who used Moyo were interviewed using a questionnaire immediately before discharge from the hospital. Twenty-eight midwives who have been using Moyo for more than 6 months were also interviewed using a structured questionnaire. Data were analyzed using excel and result presented in figures.
RESULTS
In total 113 postpartum women who were monitored using Moyo were interviewed before discharge. Out of these, 46 (40.7%) were first-time mothers and the rest were multipara. In total, 95 women (84.1%) used Moyo and other devices for FHR monitoring, 81 (72%) said Moyo was better than Fetoscopes and handheld Doppler, two-third 75 (66.4%) felt that Moyo was comfortable and 93 (82.3%) would like Moyo to be used on them in the future. Out of 28 midwives, 11 (39.3%) used Moyo continuous only, 3 (10.7%) used Moyo intermittently only and 14 (50.0%) used both intermittent and continuous. Thirteen (46.4%) midwives prefer to use Moyo both intermittent and continuous. Sixteen (55.6%) said Moyo was effective, 21 (75%) felt comfortable to use Moyo, and 13 (46.4%) said Moyo was easy to use.
CONCLUSION
The majority of midwives and women who used Moyo felt that Moyo was comfortable for intrapartum FHR monitoring. Moyo can be used both intermittently and continuously depending on the user's preferences.
PubMed: 32256129
DOI: 10.2147/MDER.S241741 -
Ultrasound in Obstetrics & Gynecology :... Jul 2020Incompatibility between currently available fetoscopes and the anatomical constraints of the distended fetal bladder, with the resulting curvature around the bladder...
OBJECTIVES
Incompatibility between currently available fetoscopes and the anatomical constraints of the distended fetal bladder, with the resulting curvature around the bladder neck, account for most technical difficulties during fetal cystoscopy in lower urinary tract obstruction (LUTO). The aim of this anatomical study was to assess by magnetic resonance imaging (MRI) the variation in three bladder angles (bladder-neck angle (BNA), vesicourethral angle (VUA) and angle between bladder dome and posterior urethra (DUA)), according to gestational age (GA), bladder volume and the presence of LUTO.
METHODS
From our fetal medicine database, we retrieved for review 46 MRI examinations of male fetuses between 2015 and 2019, including 17 with LUTO, examined at a mean GA of 28.1 (range, 17.3-35.0) weeks and 29 age-matched controls, examined at 29.9 (range, 21.9-35.0) weeks. We measured bladder volume, bladder-wall thickness and the three bladder angles, and used the Mann-Whitney U-test to compare values between groups. Variations according to GA and bladder volume were determined using analysis of variance (ANOVA). A reliability study was performed using the Bland-Altman method and Lin's correlation coefficient was calculated.
RESULTS
Both bladder volume and bladder-wall thickness were significantly greater in the LUTO group (P < 0.01). BNA was significantly larger in LUTO compared with control fetuses: the mean (range) was 127.1° (101.6-161.6°) vs 111.2° (88.5-157.3°) (P < 0.01). DUA averaged 117° and showed no difference between the groups (P = 0.92). No statistical comparison was performed on VUA since this was not measurable in most control fetuses. ANOVA showed no variation of any angle with bladder volume in both LUTO fetuses and control fetuses. BNA in LUTO fetuses was the only angle to vary with GA, being larger after, compared with at or before, 25 weeks (P = 0.04). The reliability study showed an acceptable bias for both intra- and interobserver reproducibility for all three angles.
CONCLUSION
The findings that BNA is increased by approximately 15° in fetuses with LUTO and DUA averages 117° could aid in development of a customized fetal cystoscope and help to overcome the current technical challenges of fetal cystoscopy. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
Topics: Adult; Biometry; Case-Control Studies; Cystoscopy; Female; Gestational Age; Humans; Magnetic Resonance Imaging; Male; Pregnancy; Prenatal Diagnosis; Retrospective Studies; Ultrasonography, Prenatal; Urinary Bladder Neck Obstruction
PubMed: 31006924
DOI: 10.1002/uog.20297 -
BMC Pregnancy and Childbirth Apr 2018The Doppler is thought to be more comfortable and effective compared to the fetoscope for assessing the fetal heart rate (FHR) during labor. However, in a rural...
BACKGROUND
The Doppler is thought to be more comfortable and effective compared to the fetoscope for assessing the fetal heart rate (FHR) during labor. However, in a rural Tanzanian hospital, midwives who had easy access to both devices mostly used fetoscope. This study explored midwives' perception of factors influencing their preference for using either a Pinard fetoscope or a FreePlay wind-up Doppler for intermittent FHR monitoring.
METHODS
Midwives who had worked for at least 6 months in the labor ward were recruited. Focus group discussion (FGD) was used to collect data. Five FGDs were conducted between December 2015 and February 2016. Qualitative content analysis was employed using NVivo 11.0.
RESULTS
Three main themes emerged as factors perceived by midwives as influencing their preference; 1) Sufficient training and experience with using a device; Midwives had been using fetoscopes since their midwifery training, and they had vast experience using it. The Doppler was recently introduced in the maternity ward, and midwives had insufficient training in how to use it. 2) Ability of the device to produce reliable measurements; Using a fetoscope, one must listen for the heartbeat, count using a watch, and calculate, the Doppler provides both a display and sound of the FHR. Fetoscope measurements are prone to human errors, and Doppler measurements are prone to instrumental errors. 3) Convenience of use and comfort of a device; Fetoscopes do not need charging, and while it is possible to "personalize/hide" the measurements, and may be painful for mothers. Dopplers need charging and do not cause pain, but provide limited privacy.
CONCLUSION
Midwives' preferences of FHR monitoring devices are influenced by the level of device training, experience with using a device, reliable measurements, and convenience and comfort during use. Fetoscopes and Dopplers should be equally available during midwifery training and in clinical practice.
Topics: Attitude of Health Personnel; Cardiotocography; Female; Fetoscopy; Focus Groups; Heart Rate, Fetal; Humans; Labor, Obstetric; Midwifery; Perception; Pregnancy; Qualitative Research; Rural Population; Tanzania; Ultrasonography, Doppler
PubMed: 29661165
DOI: 10.1186/s12884-018-1736-y -
Reproductive Biology and Endocrinology... May 2017The aim of this study was to compare pregnancy rates in patients undergoing IVF/ICSI with embryo transfer after 4 and 5 days of culture in a closed incubation system... (Comparative Study)
Comparative Study
BACKGROUND
The aim of this study was to compare pregnancy rates in patients undergoing IVF/ICSI with embryo transfer after 4 and 5 days of culture in a closed incubation system with integrated time-lapse imaging.
METHODS
Out of n = 2207 in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI) cycles performed between January 2011 and April 2016 at a tertiary referral university hospital, a total of n = 599 IVF/ICSI cycles with prolonged embryo culture in an integrated time-lapse system (EmbryoScope (Vitrolife)) until day 4 or 5 were retrospectively analyzed with regard to embryo morphology and pregnancy rates.
RESULTS
A transfer on day 5 compared to a transfer on day 4 did not result in higher implantation and clinical pregnancy rates (IR 29.4% on day 4 versus 33.0% on day 5, p = 0.310; CPR 45.2% on day 4 versus 45.7% on day 5, p = 1.0). The percentage of ideal embryos transferred on day 4 was comparable to the rate of ideal embryos transferred on day 5 (41.6% versus 44.1%, p = 0.508). However, on day 4 a significantly higher number of embryos was transferred (1.92 on day 4 versus 1.84 on day 5, p = 0.023), which did not result in higher rates of multiple pregnancies.
CONCLUSIONS
Pregnancy rates in IVF/ICSI cycles with integrated time-lapse incubation and transfer on day 4 and 5 are comparable. This finding provides the clinician, IVF laboratory and patient with more flexibility.
TRIAL REGISTRATION
This study was retrospectively registered by the local ethics committee of the University of Heidelberg on December 19, 2016 (registration number S-649/2016).
Topics: Adult; Cells, Cultured; Cleavage Stage, Ovum; Embryo Culture Techniques; Embryo Implantation; Embryo Transfer; Female; Fertilization in Vitro; Fetoscopes; Humans; Incubators; Infertility, Female; Pregnancy; Pregnancy Rate; Retrospective Studies; Sperm Injections, Intracytoplasmic; Time Factors; Time-Lapse Imaging
PubMed: 28482910
DOI: 10.1186/s12958-017-0253-6 -
Journal of Visualized Experiments : JoVE Feb 2017We have developed a calibration target for use with fluid-immersed endoscopes within the context of the GIFT-Surg (Guided Instrumentation for Fetal Therapy and Surgery)...
We have developed a calibration target for use with fluid-immersed endoscopes within the context of the GIFT-Surg (Guided Instrumentation for Fetal Therapy and Surgery) project. One of the aims of this project is to engineer novel, real-time image processing methods for intra-operative use in the treatment of congenital birth defects, such as spina bifida and the twin-to-twin transfusion syndrome. The developed target allows for the sterility-preserving optical distortion calibration of endoscopes within a few minutes. Good optical distortion calibration and compensation are important for mitigating undesirable effects like radial distortions, which not only hamper accurate imaging using existing endoscopic technology during fetal surgery, but also make acquired images less suitable for potentially very useful image computing applications, like real-time mosaicing. In this paper proposes a novel fabrication method to create an affordable, sterilizable calibration target suitable for use in a clinical setup. This method involves etching a calibration pattern by laser cutting a sandblasted stainless steel sheet. This target was validated using the camera calibration module provided by OpenCV, a state-of-the-art software library popular in the computer vision community.
Topics: Algorithms; Calibration; Equipment Design; Fetoscopes; Fetoscopy; Humans; Image Processing, Computer-Assisted; Optics and Photonics; Reproducibility of Results; Software; Sterilization
PubMed: 28287588
DOI: 10.3791/55298 -
Reproductive Biology and Endocrinology... Aug 2016Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging.... (Comparative Study)
Comparative Study Randomized Controlled Trial
Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study.
BACKGROUND
Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo.
RESULTS
Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time (P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation.
CONCLUSIONS
Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands.
TRIAL REGISTRATION
NCT02246309 Registered September 18, 2014.
Topics: Adult; Embryo Culture Techniques; Embryo Implantation; Embryo Transfer; Female; Fertilization in Vitro; Fetoscopes; Fetoscopy; Follow-Up Studies; Humans; Infertility, Female; Pilot Projects; Pregnancy; Prognosis; Prospective Studies; Time-Lapse Imaging; Treatment Outcome
PubMed: 27553622
DOI: 10.1186/s12958-016-0181-x -
BJOG : An International Journal of... May 2016
Topics: Artificial Intelligence; Cardiotocography; Female; Fetal Hypoxia; Fetoscopes; Heart Rate, Fetal; History, 18th Century; History, 19th Century; History, 20th Century; History, 21st Century; Humans; Labor, Obstetric; Observer Variation; Obstetrics; Pregnancy
PubMed: 27101261
DOI: 10.1111/1471-0528.13844