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      The legal frameworks that govern fetal surgery in the United Kingdom, European Union, and the United States

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          Abstract

          The specialty of fetal surgery or fetal intervention is one of the most exciting emerging fields of modern medicine. It is made possible by decades of major developments in antenatal imaging, obstetric anaesthesia, fetal medicine, paediatric surgery, and of course by the bold and novel practitioners willing to take new steps to advance the field. Beginning in the 1970s, it has now reached a stage of maturity where there are several established in utero procedures and countless clinical trials and studies to develop more. But what is the legal situation that fetal surgeons find themselves in? What are the rights and legal protections for the fetus and the mother, both of which are arguably the patient? This article will address this question, discussing and summarising the current legal frameworks governing fetal surgery in the jurisdictions of the United Kingdom, European Court of Human Rights, and the United States of America as well as discuss what the future may hold and how researchers and physicians in the specialty can best navigate the legal environment.

          Abstract

          What's already known about this topic?

          • Fetal surgery is entering mainstream clinical care as a specialty that introduces an exciting range of new treatments for mothers and their unborn babies.

          • The conflict between maternal autonomy and interests in fetal health is relatively well known. How does fetal surgery affect this issue?

          What does this study add?

          • Clarifies the legal frameworks that govern fetal surgery in the United Kingdom, European Union, and the United States.

          • Examines how fetal surgery may influence the legal position.

          • Discusses clinical best practice and how physicians can influence future laws that govern this specialty.

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          Most cited references22

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          A randomized trial of prenatal versus postnatal repair of myelomeningocele.

          Prenatal repair of myelomeningocele, the most common form of spina bifida, may result in better neurologic function than repair deferred until after delivery. We compared outcomes of in utero repair with standard postnatal repair. We randomly assigned eligible women to undergo either prenatal surgery before 26 weeks of gestation or standard postnatal repair. One primary outcome was a composite of fetal or neonatal death or the need for placement of a cerebrospinal fluid shunt by the age of 12 months. Another primary outcome at 30 months was a composite of mental development and motor function. The trial was stopped for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. This report is based on results in 158 patients whose children were evaluated at 12 months. The first primary outcome occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal-surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P<0.001). Actual rates of shunt placement were 40% in the prenatal-surgery group and 82% in the postnatal-surgery group (relative risk, 0.48; 97.7% CI, 0.36 to 0.64; P<0.001). Prenatal surgery also resulted in improvement in the composite score for mental development and motor function at 30 months (P=0.007) and in improvement in several secondary outcomes, including hindbrain herniation by 12 months and ambulation by 30 months. However, prenatal surgery was associated with an increased risk of preterm delivery and uterine dehiscence at delivery. Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00060606.).
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            An extra-uterine system to physiologically support the extreme premature lamb

            In the developed world, extreme prematurity is the leading cause of neonatal mortality and morbidity due to a combination of organ immaturity and iatrogenic injury. Until now, efforts to extend gestation using extracorporeal systems have achieved limited success. Here we report the development of a system that incorporates a pumpless oxygenator circuit connected to the fetus of a lamb via an umbilical cord interface that is maintained within a closed ‘amniotic fluid' circuit that closely reproduces the environment of the womb. We show that fetal lambs that are developmentally equivalent to the extreme premature human infant can be physiologically supported in this extra-uterine device for up to 4 weeks. Lambs on support maintain stable haemodynamics, have normal blood gas and oxygenation parameters and maintain patency of the fetal circulation. With appropriate nutritional support, lambs on the system demonstrate normal somatic growth, lung maturation and brain growth and myelination.
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              Fetoscopic laser coagulation of the vascular equator versus selective coagulation for twin-to-twin transfusion syndrome: an open-label randomised controlled trial.

              Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique).
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                Author and article information

                Contributors
                kevxcao@gmail.com
                Journal
                Prenat Diagn
                Prenat. Diagn
                10.1002/(ISSN)1097-0223
                PD
                Prenatal Diagnosis
                John Wiley and Sons Inc. (Hoboken )
                0197-3851
                1097-0223
                17 May 2018
                June 2018
                : 38
                : 7 , Special Topic Issue on Fetal Surgery ( doiID: 10.1002/pd.v38.7 )
                : 475-481
                Affiliations
                [ 1 ] Department of Urology Great Ormond Street Hospital London UK
                [ 2 ] Leicester De Montfort Law School Leicester UK
                [ 3 ] UCL Centre for Medical Image Computing London UK
                [ 4 ] UCL Institute for Women's Health London UK
                [ 5 ] Department of Development and Regeneration Katholieke Universiteit Leuven Leuven Belgium
                [ 6 ] School of Law Queen Mary University London UK
                Author notes
                [*] [* ] Correspondence

                Kevin Cao, Department of Urology, Great Ormond Street Hospital for Children, Great Ormond Street, London WC1N 3JH, UK.

                Email: kevxcao@ 123456gmail.com

                Author information
                http://orcid.org/0000-0002-9494-0946
                http://orcid.org/0000-0002-5694-5340
                http://orcid.org/0000-0002-0199-6140
                http://orcid.org/0000-0001-6065-4717
                Article
                PD5267 PD-17-0351.R3
                10.1002/pd.5267
                6033164
                29663461
                f40cdd78-d1ad-4192-824e-16b2c69c4415
                © 2018 The Authors Prenatal Diagnosis Published by John Wiley & Sons Ltd

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 31 July 2017
                : 03 April 2018
                : 05 April 2018
                Page count
                Figures: 0, Tables: 1, Pages: 7, Words: 4573
                Funding
                Funded by: Engineering and Physical Sciences Research Council (EPSRC)
                Award ID: NS/A000027/1
                Funded by: Wellcome Trust
                Award ID: WT101957
                Categories
                Review
                Reviews
                Custom metadata
                2.0
                pd5267
                June 2018
                Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.4.3 mode:remove_FC converted:05.07.2018

                Obstetrics & Gynecology
                Obstetrics & Gynecology

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