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Adnexal masses are identified in pregnant patients at a rate of 2 to 20 in 1000, approximately 2 to 20 times more frequently than in the age-matched general population. The most common types of adnexal masses in pregnancy requiring surgical management are dermoid cysts (32%), endometriomas (15%), functional cysts (12%), serous cystadenomas (11%), and mucinous cystadenomas (8%). Approximately 2% of adnexal masses in pregnancy are malignant. While most adnexal masses in pregnancy can be safely observed and around 70% spontaneously resolve, a minority warrant surgical intervention due to symptoms, risk of torsion, or suspicion for malignancy. Ultrasound is the mainstay of evaluation of adnexal masses in pregnancy due to accuracy, safety, and availability. Several ultrasound mass scoring systems, including the Sassone, Lerner, International Ovarian Tumor Analysis (IOTA) Simple Rules, and IOTA Assessment of Different NEoplasias in the adneXa (ADNEX) scoring systems have been validated specifically in pregnant populations. Decisions regarding expectant versus surgical management of adnexal masses in pregnancy must balance the risks of torsion or malignancy with the likelihood of spontaneous resolution and the risks of surgery. Laparoscopic surgery is preferred over open surgery when possible due to consistently demonstrated shorter hospital length of stay and less post-operative pain, as well as some data demonstrating shorter operative time, lower blood loss, and lower risks of fetal loss, pre-term birth, and low birth weight. Best practices for laparoscopic surgery during pregnancy include left lateral decubitus positioning after the first trimester, port placement with respect to uterine size and pathology location, insufflation pressure of less than 12-15 mm Hg, intraoperative maternal capnography, pre- and post-operative fetal heart rate and contraction monitoring, and appropriate mechanical and chemical thromboprophylaxis. While planning surgery for the second trimester generally affords time for mass resolution while optimizing visualization with regards to uterine size and pathology location, necessary surgery should not be delayed due to gestational age. When performed at a facility with appropriate obstetric, anesthetic, and neonatal support, adnexal surgery in pregnancy generally results in excellent outcomes for mother and fetus. [ABSTRACT FROM AUTHOR]

Open spina bifida is the most common congenital anomaly of the central nervous system compatible with life. Prenatal repair of open spina bifida via open maternal-fetal surgery has been shown to improve postnatal neurologic outcomes, including reducing the need for ventriculoperitoneal shunting and improving lower neuromotor function. Fetoscopic repair of open spina bifida minimizes the maternal risks while providing similar neurosurgical outcomes to the fetus. The following 2 fetoscopic techniques are currently in use: (1) the laparotomy-assisted approach, and (2) the percutaneous approach. The laparotomy-assisted fetoscopic technique appears to be associated with a lesser risk of preterm birth than the percutaneous approach. However, the percutaneous approach avoids laparotomy and uterine exteriorization and is associated with lesser anesthesia risk and improved maternal postsurgical recovery. The purpose of this article was to describe our experience with a modified surgical approach, which we call percutaneous/mini-laparotomy fetoscopy, in which access to the uterus for one of the ports is done via a mini-laparotomy, whereas the other ports are inserted percutaneously. This technique draws on the benefits of both the laparotomy-assisted and the percutaneous techniques while minimizing their drawbacks. This surgical approach may prove invaluable in the prenatal repair of open spina bifida and other complex fetal surgical procedures. [ABSTRACT FROM AUTHOR]

Intraoperative blood transfer between twins during laser surgery for twin-twin transfusion syndrome can vary by surgical technique and has been proposed to explain differences in donor twin survival. This trial compared donor twin survival with 2 laser techniques: the sequential technique, in which the arteriovenous communications from the volume-depleted donor to the volume-overloaded recipient are laser-occluded before those from recipient to donor, and the selective technique, in which the occlusion of the vascular communications is performed in no particular order. A single-center, open-label, randomized controlled trial was conducted in which twin-twin transfusion syndrome patients were randomized to sequential vs selective laser surgery. Nested within the trial, a second trial randomized patients with superficial anastomoses (arterioarterial and venovenous) to ablation of these connections first (before ablating the arteriovenous anastomoses) vs last. The primary outcome measure was donor twin survival at birth. A total of 642 patients were randomized. Overall donor twin survival was similar between the 2 groups (274 of 320 [85.6%] vs 271 of 322 [84.2%]; odds ratio, 1.12 [95% confidence interval, 0.73–1.73]; P =.605). Superficial anastomoses occurred in 177 of 642 cases (27.6%). Donor survival was lower in the superficial anastomosis group vs those with only arteriovenous communications (125 of 177 [70.6%] vs 420 of 465 [90.3%]; adjusted odds ratio, 0.33 [95% confidence interval, 0.20–0.54]; P <.001). In cases with superficial anastomoses, donor survival was independent of the timing of ablation or surgical technique. The postoperative mean middle cerebral artery peak systolic velocity was lower in the sequential vs selective group (1.00±0.30 vs 1.06±0.30 multiples of the median; P =.003). Post hoc analyses showed 2 factors that were associated with poor overall donor twin survival: the presence or absence of donor twin preoperative critical abnormal Doppler parameters and the presence or absence of arterioarterial anastomoses. Depending on these factors, 4 categories of patients resulted: (1) Category 1 (347 of 642 [54%]), no donor twin critical abnormal Doppler + no arterioarterial anastomoses: donor twin survival was 91.2% in the sequential and 93.8% in the selective groups; (2) Category 2 (143 of 642 [22%]), critical abnormal Doppler present + no arterioarterial anastomoses: donor survival was 89.9% vs 75.7%; (3) Category 3 (73 of 642 [11%]), no critical abnormal Doppler + arterioarterial anastomoses present: donor survival was 94.7% vs 74.3%; and (4) Category 4 (79 of 642 [12%]), critical abnormal Doppler present + arterioarterial anastomoses present: donor survival was 47.6% vs 64.9%. Donor twin survival did not differ between the sequential vs selective laser techniques and did not differ if superficial anastomoses were ablated first vs last. The donor twin's postoperative middle cerebral artery peak systolic velocity was improved with the sequential vs the selective approach. Post hoc analyses suggest that donor twin survival may be associated with the choice of laser technique according to high-risk factors. Further study is needed to determine whether using these categories to guide the choice of surgical technique will improve outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

Pain is a complex phenomenon that involves more than a simple physical response to external stimuli. In maternal-fetal surgical procedures, fetal analgesia is used primarily to blunt fetal autonomic responses and minimize fetal movement. The purpose of this Consult is to review the literature on what is known about the potential for fetal awareness of pain and to discuss the indications for and the risk-benefit calculus involved in the use of fetal anesthesia and analgesia. The recommendations by the Society for Maternal-Fetal Medicine are as follows: (1) we suggest that fetal paralytic agents be considered in the setting of intrauterine transfusion, if needed, for the purpose of decreasing fetal movement (GRADE 2C); (2) although the fetus is unable to experience pain at the gestational age when procedures are typically performed, we suggest that opioid analgesia should be administered to the fetus during invasive fetal surgical procedures to attenuate acute autonomic responses that may be deleterious, avoid long-term consequences of nociception and physiological stress on the fetus, and decrease fetal movement to enable the safe execution of procedures (GRADE 2C); and (3) due to maternal risk and a lack of evidence supporting benefit to the fetus, we recommend against the administration of fetal analgesia at the time of pregnancy termination (GRADE 1C). [ABSTRACT FROM AUTHOR]

Antenatal corticosteroids have been used for the prevention of respiratory complications, intraventricular hemorrhage, necrotizing enterocolitis, and other adverse neonatal outcomes for over 50 years, with limited evidence about their optimal doses. Higher steroid doses or frequencies of antenatal corticosteroids in preterm newborns pose adverse effects such as prolonged adrenal suppression, negative effects on fetal programming and metabolism, and increased risks of neurodevelopmental and neuropsychological impairments. Conversely, lower doses of antenatal corticosteroids may be an effective alternative to induce fetal lung maturation with less risk to the fetus. Late preterm births represent the largest population of all preterm neonates, with a respiratory distress syndrome risk of 8.83%. Therefore, determining the optimal antenatal corticosteroid dosage is of particular importance for this population. This study aimed to compare the efficacy of 5-mg and 6-mg dexamethasone in preventing neonatal respiratory distress syndrome in women with preterm births at 320 to 366 weeks of gestation. This was an open-label, randomized, controlled, noninferiority trial. Singleton pregnant women (n=370) at 320 to 366 weeks of gestation with spontaneous preterm labor or preterm premature rupture of membranes were enrolled. They were randomly assigned (1:1) to a 5-mg or 6-mg dexamethasone group. Dexamethasone was administered intramuscularly every 12 hours for 4 doses or until delivery. The primary outcome was the reduction in neonatal respiratory distress syndrome cases, whereas the secondary outcomes were any adverse maternal or neonatal events. Between December 2020 and April 2022, 370 eligible women, anticipating deliveries within the gestational range of 32 0/7 to 36 6/7 weeks, willingly participated in the study. They were evenly split, with 185 women assigned to the 5-mg group and 185 to the 6-mg group. The study revealed that the demographic profiles of the participants in the 2 groups were remarkably similar, with no statistically significant disparities (P >.05). It is noteworthy that most of these women gave birth after 34 weeks of gestation. Despite a substantial proportion not completing the full course of steroid treatment, the 5-mg dose exhibited noninferiority compared with the 6-mg dose of dexamethasone, as indicated by a modest proportional difference of 0.5% (95% confidence interval, −2.8 to 43.9). Neonatal respiratory distress syndrome occurred in a relatively low percentage of newborns in both groups, affecting 2.2% in the 5-mg group and 1.6% in the 6-mg group. Notably, the risk difference of 0.6% fell comfortably within the predefined noninferiority threshold of 10%. Our study suggests that a 5-mg dexamethasone dose is noninferior to a standard 6-mg dose in preventing neonatal respiratory distress syndrome in preterm births. [Display omitted] [ABSTRACT FROM AUTHOR]

Vasa previa is an obstetrical condition in which fetal vessels located near the cervix traverse the fetal membranes unprotected by underlying placenta. Type I vasa previa arises directly from a velamentous cord root, whereas types II and III arise from an accessory lobe or a distal lobe of the same placenta, respectively. Fetoscopic laser ablation for types II and III vasa previa is a novel therapeutic option with benefits that include surgical resolution of the vasa previa, avoidance of prolonged hospitalization, and opportunity for a term vaginal delivery. The potential risks of fetoscopy can be mitigated by delaying laser surgery until a gestational age of 31 to 33 weeks, immediately before anticipated hospitalized surveillance. This study aimed to assess feasibility and outcomes of types II and III vasa previa patients treated via fetoscopic laser ablation in the third trimester. This is a retrospective study of singleton pregnancies with types II and III vasa previa treated with fetoscopic laser ablation at a gestational age ≥31 weeks at a single center between 2006 and 2022. Pregnancy and newborn outcomes were assessed. Continuous variables are expressed as mean±standard deviation. Of 84 patients referred for vasa previa, 57 did not undergo laser ablation: 19 either had no or resolved vasa previa, 25 had type I vasa previa (laser-contraindicated), and 13 had type II or III vasa previa but declined laser treatment. Of the remaining 27 patients who underwent laser ablation, 7 were excluded (laser performed at <31 weeks and/or twins), leaving 20 study patients. The mean gestational age at fetoscopic laser ablation was 32.0±0.6 weeks, and total operative time was 62.1±19.6 minutes. There were no perioperative complications. All patients had successful occlusion of the vasa previa vessels (1 required a second procedure). All patients were subsequently managed as outpatients. The mean gestational age at delivery was 37.2±1.8 weeks, the mean birthweight was 2795±465 g, and 70% delivered vaginally. Neonatal intensive care unit admission occurred in 3 cases: 1 for respiratory distress syndrome and 2 for hyperbilirubinemia requiring phototherapy. There were no cases of neonatal transfusion, intraventricular hemorrhage, sepsis, patent ductus arteriosus, or death. Laser ablation for types II and III vasa previa at 31 to 33 gestational weeks was technically achievable and resulted in favorable outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

There has been growing concern about the detrimental effects of certain anesthetic agents on the developing brain. Preclinical studies in small animal models as well as nonhuman primates suggested loss or death of brain cells and consequent impaired neurocognitive function following anesthetic exposure in neonates and late gestation fetuses. Human studies in this area are limited and currently inconclusive. On Dec. 14, 2016, the US Food and Drug Administration issued a warning regarding impaired brain development in children following exposure to certain anesthetic agents used for general anesthesia, namely the inhalational anesthetics isoflurane, sevoflurane, and desflurane, and the intravenous agents propofol and midazolam, in the third trimester of pregnancy. Furthermore, this warning recommends that health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against potential risks, especially for procedures that may last >3 hours or if multiple procedures are required in children <3 years old. The objective of this article is to highlight how the Food and Drug Administration warning may impact the anesthetic and surgical management of the obstetric patient. Neuraxial anesthesia (epidural or spinal anesthesia) is more commonly administered for cesarean delivery than general anesthesia. The short duration of fetal exposure to general anesthesia during cesarean delivery has not been associated with learning disabilities. However, the fetus can also be exposed to both intravenous and inhalation anesthetics during nonobstetric or fetal surgery in the second and third trimester; this exposure is typically longer than that for cesarean delivery. Very few studies address the effect of anesthetic exposure on the fetus in the second trimester when most nonobstetric and fetal surgical procedures are performed. It is also unclear how the plasticity of the fetal brain at this stage of development will modulate the consequences of anesthetic exposure. Strategies that may circumvent possible untoward long-term neurologic effects of anesthesia in the baby include: (1) use of nonimplicated (nongamma-aminobutyric acid agonist) agents for sedation such as opioids (remifentanil, fentanyl) or the alpha-2 agonist, dexmedetomidine, when appropriate; (2) minimizing the duration of exposure to inhalational anesthetics for fetal, obstetric, and nonobstetric procedures in the pregnant patient, as much as possible within safe limits; and (3) commencing surgery promptly and limiting the interval between induction of anesthesia and surgery start time will help decrease patient exposure to inhalational agents. While the Food and Drug Administration warning was based on duration and repetitive nature of exposure rather than concentration of inhalational agents, intravenous tocolytics can be considered for intraoperative use, to provide uterine relaxation for fetal surgery, in lieu of high concentrations of inhalational anesthetic agents. Practitioners should consider the type of anesthesia that will be administered and the potential risks when scheduling patients for nonobstetric and fetal surgery. [ABSTRACT FROM AUTHOR]

In utero repair of open neural tube defects using an open hysterotomy approach (hereafter referred to as "open") has been shown to reduce the need for ventriculoperitoneal shunting and to improve motor outcomes for affected infants. Laparotomy-assisted fetoscopic repair (hereafter referred to as "hybrid") is an alternative approach that may confer similar neurologic benefits while reducing the incidence of hysterotomy-related complications. This study aimed to analyze procedure-related maternal and fetal complications of in utero repair using the Clavien–Dindo classification, and to compare the outcomes of the hybrid and open approaches. This was a retrospective cohort study conducted in a single center between September 2011 and July 2021. All patients who met the Management of Myelomeningocele Study criteria and who underwent either hybrid or open fetal surgery were included. Maternal complications were classified using a unique adaptation of the Clavien–Dindo scoring system, allowing the development of a comprehensive complication index score specific to fetal surgery. Primary fetal outcome was defined as gestational age at delivery and summarized according to the World Health Organization definitions of preterm delivery. There were 146 fetuses with open neural tube defects who were eligible for, and underwent, in utero repair during the study period. Of these, 102 underwent hybrid fetoscopic repair and 44 underwent open hysterotomy repair. Gestational age at the time of surgery was higher in the hybrid group than in the open group (25.1 vs 24.8 weeks; P =.004). Maternal body mass index was lower in the hybrid than in the open group (25.4 vs 27.1 kg/m2; P =.02). The duration of hybrid fetoscopic surgery was significantly longer in the hybrid than in the open group (250 vs 164 minutes; P <.001). There was a significantly lower Clavien–Dindo Grade III complication rate (4.9% vs 43.2%; P <.001) and a significantly lower overall comprehensive maternal complication index (8.7 vs 22.6; P =.021) in the hybrid group than in the open group. Gestational age at delivery was significantly higher in the hybrid group than in the open group (38.1 vs 35.8 weeks; P <.001), and this finding persisted when gestational age at delivery was analyzed using the World Health Organization definitions of preterm delivery. Use of our adaptation of the standardized Clavien–Dindo classification to assess the maternal complications associated with in utero open neural tube defect repair provides a new method for objectively assessing different fetal surgical approaches. It also provides a much-needed standardized tool to allow objective comparisons between methods, which can be used when counseling patients. The hybrid open neural tube defect repair was associated with lower rates of maternal adverse events , and later gestational age at delivery compared with the open approach. [ABSTRACT FROM AUTHOR]

The functional maternal-fetal hemodynamic unit includes fetal umbilical vein flow and maternal peripheral vascular resistance. This study investigated the relationships between maternal and fetal hemodynamics in a population with suspected fetal growth restriction. This was a prospective study of normotensive pregnancies referred to our outpatient clinic for a suspected fetal growth restriction. Maternal hemodynamics measurement was performed, using a noninvasive device (USCOM-1A) and a fetal ultrasound evaluation to assess fetal biometry and velocimetry Doppler parameters. Comparisons among groups were performed with 1-way analysis of variance with Student-Newman-Keuls correction for multiple comparisons and with Kruskal-Wallis test where appropriate. The Spearman rank coefficient was used to assess the correlation between maternal and fetal hemodynamics. Pregnancies were observed until delivery. A total of 182 normotensive pregnancies were included. After the evaluation, 54 fetuses were classified as growth restricted, 42 as small for gestational age, and 86 as adequate for gestational age. The fetus with fetal growth restriction had significantly lower umbilical vein diameter (P <.0001), umbilical vein velocity (P =.02), umbilical vein flow (P <.0001), and umbilical vein flow corrected for fetal weight (P <.01) than adequate-for-gestational-age and small-for-gestational-age fetuses. The maternal hemodynamic profile in fetal growth restriction was characterized by elevated systemic vascular resistance and reduced cardiac output. The umbilical vein diameter was positively correlated to maternal cardiac output (r s =0.261), whereas there was a negative correlation between maternal systemic vascular resistance (r s =−0.338) and maternal potential energy–to–kinetic energy ratio (r s =−0267). The fetal umbilical vein time averaged max velocity was positively correlated to maternal cardiac output (r s =0.189) and maternal inotropy index (r s =0.162), whereas there was a negative correlation with maternal systemic vascular resistance (r s =−0.264) and maternal potential energy–to–kinetic energy ratio (r s =−0.171). The fetal umbilical vein flow and the flow corrected for estimated fetal weight were positively correlated with maternal cardiac output (r s =0.339 and r s =0.297) and maternal inotropy index (r s =0.217 and r=0.336), whereas there was a negative correlation between maternal systemic vascular resistance (r s =−0.461 and r s =−0.409) and maternal potential energy–to–kinetic energy ratio (r s =−0.336 and r s =−0.408). Maternal and fetal hemodynamic parameters were different in the 3 groups of fetuses: fetal growth restriction, small for gestational age, and adequate for gestational age. Maternal hemodynamic parameters were closely and continuously correlated with fetal hemodynamic features. In particular, a maternal hemodynamic profile with high systemic vascular resistance, low cardiac output, reduced inotropism, and hypodynamic circulation was correlated with a reduced umbilical vein flow and increased umbilical artery pulsatility index. The mother, placenta, and fetus should be considered as a single cardiac-fetal-placental unit. The correlations of systemic vascular resistance, cardiac output, and inotropy index with umbilical artery impedance indicate the key role of these 3 parameters in placental vascular tree development. The umbilical vein flow rate and, therefore, the placental perfusion seems to be influenced not only by these three parameters but also by the maternal cardiovascular kinetic energy. [ABSTRACT FROM AUTHOR]

Background: Esophageal atresia is a major anomaly of varying severity. The complexity of surgical correction depends on the presence of a distal fistula.Objective: This study aimed to determine the feasibility and accuracy of prenatal ultrasound detection of the distal fistula in fetuses diagnosed with esophageal atresia.Study Design: This was an observational study conducted at a single tertiary care center between 2019 and 2021. Included were pregnant patients carrying a fetus prenatally diagnosed with esophageal atresia that was confirmed postnatally during corrective surgery or at postmortem autopsy. During the scan, the performing investigator determined the presence or absence of a distal fistula by scanning the location of the lower esophagus during fetal breathing. Cases in which the lower esophagus was observed distending with amniotic fluid during breathing were deemed "fistula present," and the remaining cases "fistula absent." Test feasibility and performance indices, including sensitivity, specificity, and positive and negative predictive value were calculated. The offline clips and images were reviewed by 2 investigators for the assessment of interoperator agreement using Cohen's Kappa formula.Results: Included were 16 fetuses with esophageal atresia scanned between 2019 and 2021. All fetuses were successfully scanned with sufficient resolution of the area of interest during at least 3 cycles of breathing. It took a median of 8.5 minutes to determine the presence or absence of a distal fistula. The feasibility of the test was 100% (16/16). The test's sensitivity, specificity, and positive and negative predictive values were 80% (95% confidence interval, 55-100), 100% (95% confidence interval, 60-100), 100% (95% confidence interval, 65-100), and 75% (95% confidence interval, 45-100), respectively. The Cohen's Kappa for interoperator agreement was calculated to be 1, P<.001, corresponding to a "perfect" level of agreement.Conclusion: Distal fistulas in esophageal atresia can be demonstrated prenatally by targeted scanning using appropriate technique. The method provided is feasible, reproducible, and has excellent performance indices. This novel technique and observations may improve the prenatal diagnosis and counseling of esophageal atresia. [ABSTRACT FROM AUTHOR]

Background: Complete coagulation of the vascular equator (as in the Solomon technique) has been suggested to reduce postoperative complications such as twin anemia polycythemia syndrome and the recurrence of twin-twin transfusion syndrome following fetoscopic laser coagulation of chorionic vessels for twin-twin transfusion syndrome.Objective: We aimed to evaluate the benefit of this technique on perinatal outcomes compared with selective ablation of anastomoses.Study Design: We conducted a monocentric retrospective study comparing selective laser coagulation of anastomoses to the Solomon technique from January 2006 to August 2020. To adjust for potential confounders, the cases operated by selective surgery were matched to the cases operated with the Solomon technique according to the gestational age at laser therapy, placental localization, and Quintero stage using propensity score matching.Results: With a total of 994 cases, 399 matched pairs were included in the analysis. Compared with selective ablation, the Solomon technique was associated with significantly improved survival: the overall twin survival at delivery and discharge was 72% vs 79% (P=.003) and 69% vs 75% (P=.006), respectively; the double twin survival rate at discharge was 55% vs 65% (P=.02), respectively, and the rate of intrauterine death dropped from 18% to 12% (P=.003), respectively. The Solomon technique significantly reduced the rate of twin anemia polycythemia syndrome (10% vs 4%; P=.02), leading to fewer secondary rescue procedures (13% vs 7.3%; P=.01). However, the Solomon technique was associated with an increased risk of preterm rupture of membranes, especially at early gestational ages (3.8% vs 11%; P<.001 for preterm rupture of membranes <24 weeks). Among the survivors at delivery, both the groups had similar gestational ages at birth. Both neonatal mortality and severe neurologic morbidity were similar in both the groups. However, an increased risk of bronchopulmonary dysplasia was found in the Solomon group (4.5% vs 12%; P<.001).Conclusion: Although the risk of preterm premature rupture of membranes has increased, the introduction of the Solomon technique has significantly improved perinatal outcomes in pregnancies affected with twin-twin transfusion syndrome. [ABSTRACT FROM AUTHOR]

Following the promising multicenter randomized trial results of in utero fetal myelomeningocele repair; we anticipate that an increasing number of tertiary care centers may want to offer this therapy. It is essential to establish minimum criteria for centers providing open fetal myelomeningocele repair to ensure optimal maternal and fetal/pediatric outcomes, as well as patient safety both short- and long-term; and to advance our knowledge of the role and benefit of fetal surgery in the management of fetal myelomeningocele. The fetal myelomeningocele Maternal-Fetal Management Task Force was initially convened by the Eunice Kennedy Shriver National Institute of Child Health and Human Development to discuss the implementation of maternal fetal surgery for myelomeningocele. The decision was made to develop the optimal practice criteria presented in this document for the purpose of medical and surgical leadership. These criteria are not intended to be used for legal or regulatory purposes. [ABSTRACT FROM AUTHOR]

Background: Two randomized controlled trials compared the neonatal and infant outcomes after fetoscopic endoluminal tracheal occlusion with expectant prenatal management in fetuses with severe and moderate isolated congenital diaphragmatic hernia, respectively. Fetoscopic endoluminal tracheal occlusion was carried out at 27+0 to 29+6 weeks' gestation (referred to as "early") for severe and at 30+0 to 31+6 weeks ("late") for moderate hypoplasia. The reported absolute increase in the survival to discharge was 13% (95% confidence interval, -1 to 28; P=.059) and 25% (95% confidence interval, 6-46; P=.0091) for moderate and severe hypoplasia.Objective: Data from the 2 trials were pooled to study the heterogeneity of the treatment effect by observed over expected lung-to-head ratio and explore the effect of gestational age at balloon insertion.Study Design: Individual participant data from the 2 trials were reanalyzed. Women were assessed between 2008 and 2020 at 14 experienced fetoscopic endoluminal tracheal occlusion centers and were randomized in a 1:1 ratio to either expectant management or fetoscopic endoluminal tracheal occlusion. All received standardized postnatal management. The combined data involved 287 patients (196 with moderate hypoplasia and 91 with severe hypoplasia). The primary endpoint was survival to discharge from the neonatal intensive care unit. The secondary endpoints were survival to 6 months of age, survival to 6 months without oxygen supplementation, and gestational age at live birth. Penalized regression was used with the following covariates: intervention (fetoscopic endoluminal tracheal occlusion vs expectant), early balloon insertion (yes vs no), observed over expected lung-to-head ratio, liver herniation (yes vs no), and trial (severe vs moderate). The interaction between intervention and the observed over expected lung-to-head ratio was evaluated to study treatment effect heterogeneity.Results: For survival to discharge, the adjusted odds ratio of fetoscopic endoluminal tracheal occlusion was 1.78 (95% confidence interval, 1.05-3.01; P=.031). The additional effect of early balloon insertion was highly uncertain (adjusted odds ratio, 1.53; 95% confidence interval, 0.60-3.91; P=.370). When combining these 2 effects, the adjusted odds ratio of fetoscopic endoluminal tracheal occlusion with early balloon insertion was 2.73 (95% confidence interval, 1.15-6.49). The results for survival to 6 months and survival to 6 months without oxygen dependence were comparable. The gestational age at delivery was on average 1.7 weeks earlier (95% confidence interval, 1.1-2.3) following fetoscopic endoluminal tracheal occlusion with late insertion and 3.2 weeks earlier (95% confidence interval, 2.3-4.1) following fetoscopic endoluminal tracheal occlusion with early insertion compared with expectant management. There was no evidence that the effect of fetoscopic endoluminal tracheal occlusion depended on the observed over expected lung-to-head ratio for any of the endpoints.Conclusion: This analysis suggests that fetoscopic endoluminal tracheal occlusion increases survival for both moderate and severe lung hypoplasia. The difference between the results for the Tracheal Occlusion To Accelerate Lung growth trials, when considered apart, may be because of the difference in the time point of balloon insertion. However, the effect of the time point of balloon insertion could not be robustly assessed because of a small sample size and the confounding effect of disease severity. Fetoscopic endoluminal tracheal occlusion with early balloon insertion in particular strongly increases the risk for preterm delivery. [ABSTRACT FROM AUTHOR]

Objective: The objective of the study was to reproduce severe forms of extremity amniotic bands, which result in amputation or severe lesions. Study design: Right limbs of 5 60-day gestational age pregnant sheep were ligated with silk suture at the infracondilar level. Left limbs were used for paired comparison. The limbs obtained from term fetuses were analyzed morphologically, radiologically, and histologically. Results: The ligated limbs showed an amputation or quasiamputation. Four extremities showed a necrotic pattern and 4 an edema pattern. Conclusion: A model of severe extremity amniotic bands that reproduces the effect of the extremity amniotic bands in the human fetus was developed. Future applications of this new model could be an experimental study of in utero salvage of limbs affected with severe extremity amniotic bands in the ovine fetus. [ABSTRACT FROM AUTHOR]

Objective: This study was undertaken to examine short-term neurodevelopmental outcomes in children with myelomeningocele (MMC) who underwent in utero neurosurgical closure. Study design: Between 1998 and 2002, 51 fetuses underwent in utero MMC closure at our Center. Thirty (63%) of these children have returned for neurodevelopmental testing at 2 years of age using the Bayley Scales of Infant Development and Preschool Language Scales. Results: Overall shunt rate was 43% in this group. Neurodevelopmental testing found 67% with cognitive language and personal-social skills in the normal range, 20% with mild delays, and 13% with significant delays. Children with shunted hydrocephalus scored lower than those with un-shunted ventriculomegaly. Conclusion: Children who have undergone fetal MMC closure have characteristic neurodevelopmental deficits that do not appear worsened by fetal surgery, and developmental outcomes may be improved by decreasing the need for ventriculoperitoneal shunting. [ABSTRACT FROM AUTHOR]

Objective: This study was undertaken to characterize risk factors associated with nonanomalous stillborn (SB) infants and to ascribe the probability of fetal survival by gestational age among high-risk pregnancies. Study design: We compiled a database of all SB infants and an equivalent number of controls using information obtained from Utah Birth and Fetal Death Certificates during the years 1992 through 2002. Adjusted and unadjusted odds ratios for risk factors associated with SB were generated. Cox proportional hazard models were used to generate survival curves comparing pregnancies complicated by chronic hypertension or gestational hypertension with those of controls. Results: Infants with major anomalies were eliminated from both cases and controls, to generate 1566 nonanomalous SBs and 2720 nonanomalous controls. In a logistic regression model controlling for multiple maternal and fetal factors, placental abruption, hydramnios, cord prolapse, and essential hypertension were associated with an increased risk of SB. In pregnancies complicated by essential hypertension, the survival curve diverged from that of controls at those gestational ages approaching term (hazard ratio 2.24; 95% CI 1.52-3.32). Conclusion: SB in nonanomalous infants in Utah is more common among pregnancies complicated by placental abruption, hydramnios, cord prolapse, and essential hypertension. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to determine how closely the surgically induced sheep myelomeningocele (MMC) model resembles the central nervous system derangements seen in human disease, and identify which aspects of MMC are the result of the early neuronal developmental defect, and which are secondary to the cerebrospinal fluid (CSF) drainage. Study design: An MMC-like lesion was created surgically in 16 fetal sheep at 75 days' gestation: 5 died in utero, 7 underwent no fetal repair, 4 were repaired (2-layer closure or biological glue) at 100 days' gestation. MMC sheep were delivered at term and allowed to survive up to 17 days for analysis of behavioral status and feeding behavior. Animals not repaired in utero were repaired at birth. All lambs were sacrificed and analyzed for hindbrain herniation, hydrocephalus, and other CNS derangements. Results: Hindbrain herniation was observed in 43% of animals not repaired in utero, and in 1 lamb repaired with Bioglue, No animal developed hydrocephalus or other CNS derangements. Conclusion: Although this sheep MMC-like model reproduces the CSF leak, but not the developmental defect seen in humans, it suggests CSF leak contributes to hindbrain herniation seen in humans. This model may be useful to develop new minimally invasive techniques to halt CSF leak in utero. [ABSTRACT FROM AUTHOR]

Objective: Amniotic access for fetal diagnosis and therapy can lead to membrane leaks, separation, and preterm premature rupture of membranes. Morbidity limits the beneficial effects of fetal intervention. We propose to examine a novel preventive "presealant" membrane puncture technique and evaluate it in vitro. Study design: Fetal membranes from normal term deliveries were fastened to a pressure controlled pump and punctured after presealant placement. Distinct bioadhesixes were then compared for sealing efficacy by the measurement of leak pressures. Membranes were also evaluated for changes in tensile rupture strength after treatment. Results: Preemptive sealing by 2 of the presealants achieved significantly higher leak pressures compared with control membranes (85 and 78, respectively, vs 27 cm of water; P < .05). One of the presealants worked effectively in a membrane-sealant-membrane interface (62 vs 30 cm of water; P < .05). All treated membranes, however, demonstrated diminished tensile rupture forces compared with control membranes (124 vs 170 g/cm²; P > .05). Conclusion: The application of a presealant is effective for the prevention of iatrogenic rupture in an in vitro model and may be beneficial for clinical application. Further studies with different bioadhesives are needed, given the limitations of the glues that are described in this study. [ABSTRACT FROM AUTHOR]

Objective: Intrauterine myelomeningocele (MMC) repair decreases hindbrain herniation and the need for postnatal ventriculoperitoneal shunting. We examined the impact of intrauterine repair on the progression of ventriculomegaly in utero. Study design: Fetuses with MMC were identified through computerized databases from June 1988 to April 2003. A retrospective cohort design was used to evaluate the impact of intrauterine repair on ventricular progression with a multivariate linear regression model that included baseline ventricle measurement, gestational age, level of lesion, and gender. Results: Fourteen fetuses with intrauterine repair and 39 fetuses with postnatal repair were identified. The natural history of progression of ventricular diameter increased in a linear fashion throughout gestation (0.57 mm/week). After adjusting for confounding variables, no transient or sustained difference was observed in the rate progression of ventriculomegaly between intrauterine and postnatal repair (0.27 ± 0.35 mm/week; P = .45). Conclusion: Intrauterine MMC repair does not impact the progression of ventriculomegaly. [ABSTRACT FROM AUTHOR]

Objective: The study was undertaken to evaluate short-term clinical outcomes with antenatal myelomeningocele (MMC) repair.Study Design: Retrospective review of 50 fetuses that underwent open fetal MMC closure was performed. Inclusion criteria included less than 26 weeks' gestation, thoracic to S1 level defect, absent clubfoot deformity, Arnold-Chiari malformation, ventriculomegaly less than 17 mm, normal karyotype, and no other anomalies.Results: Perinatal survival was 94% (47/50 fetuses). Mean age at delivery was 34 weeks 3 days. All fetuses demonstrated reversal of hindbrain herniation. Forty-three percent of the 50 fetuses have required ventriculoperitoneal shunting compared with 100% thoracic, 88% lumbar, and 68% sacral (85% overall) in 297 historic controls. Better-than-predicted leg function was seen in 57% of thoracic and lumbar level lesion patients.Conclusion: Early experience with fetal MMC repair suggests a decreased need for ventriculoperitoneal shunting, arrest or slowing of progressive ventriculomegaly, and consistent resolution of hindbrain herniation. However, further long-term follow-up is needed to evaluate neurodevelopment and bladder and bowel function. [ABSTRACT FROM AUTHOR]

The transition from innovation to standard of care for fetal surgery should be guided by ethical considerations. We provide an ethical framework that identifies criteria for the investigation of fetal surgery. This framework addresses the initiation and assessment of clinical trials to determine whether they establish a standard of care, describes an appropriate informed consent process, considers whether selection criteria should include the abortion preferences of the pregnant woman, and considers whether physicians have an obligation to offer referral to such investigation. This ethical framework, in a clinically comprehensive fashion, takes account of the physician's obligations to the fetal patient, the pregnant woman, and future fetal and pregnant patients. We apply this framework to clinical investigations of fetal surgery for spina bifida. [ABSTRACT FROM AUTHOR]

Objective: Our purpose was to evaluate in a sheep model for endoscopic fetal surgery the impact of nitrous oxide-gas amniodistention compared with fluid amniodistention on duration of surgery, hemorrhagic events, and fetomaternal acid-base status.Study Design: Pregnant ewes (n = 16) at 92 to 104 days of gestation (term, 145 days) underwent amniodistention with Hartmann's solution (group I, n = 8) or nitrous oxide (group II, n = 8) at 38 degrees C. Endoscopic tracheal clipping according to a standardized surgical protocol was performed in all animals. The duration of fetoscopy (from insertion of first cannula until removal of last one), fetal surgery (fetal skin incision to skin closure), and number of bleeding episodes was recorded. Maternal and fetal blood gas values (pH, PO2, and PCO2) were measured at baseline and every 15 minutes during the experiment. Videotapes of the operations were assessed independently and scored by a visual analog scale in terms of smoothness of the operation and control of hemorrhagic events.Results: Mean duration of fetoscopy (+/-SEM) (68 +/- 16 minutes vs 92 +/- 23 minutes) and fetal surgery (19 +/- 6 minutes vs 42 +/- 18 minutes) as well as number of bleeding episodes (1.9 +/- 0.8 minutes vs 5.8 +/- 2.1 minutes) was significantly reduced in animals operated with use of nitrous oxide amniodistention. In both groups, fetal and maternal blood gases remained unchanged during the entire experiment. Visual analog scale (VAS) scores were significantly higher for procedures conducted with use of gas distention.Conclusion: In a lamb model for fetal surgery, gas amniodistention with use of nitrous oxide results in a quicker operation procedure with less bleeding compared with fluid amniodistention, and without adverse side effects on fetomaternal acid-base status. [ABSTRACT FROM AUTHOR]

Illustrates the feasibility of preoperative planning with magnetic resonance imaging, 3-dimensional reconstruction, and volume-rendering techniques in twin-to-twin transfusion syndrome treated by endoscopic laser ablation of communicating vessels. Determination of the syndrome and the indications for intervention; Assignment of colors or shades of gray to separate organs or tissues; Anatomic relationships between fetuses and placental vessels.

Examines the effects of myelomeningocele prenatal repair on hindbrain herniation in fetal lambs. Observation of hernia development in lambs with myelomeningocele repair; Condition of fetal brains following hysterectomy; Details on the prenatal repair of myelomeningocele; Implication for the prevention of hindbrain herniation.

Describes the performance of fetal hydrolaparascopy and endoscopic fetal cystotomy in two fetuses with complicated lower obstructive uropathy. Cases where the method was performed; Adequate bladder drainage obtained; Effectiveness of the method; Indications for the procedure.