{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:54:19Z","timestamp":1753880059737,"version":"3.41.2"},"reference-count":24,"publisher":"ASME International","issue":"2","license":[{"start":{"date-parts":[[2020,12,18]],"date-time":"2020-12-18T00:00:00Z","timestamp":1608249600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.asme.org\/publications-submissions\/publishing-information\/legal-policies"}],"content-domain":{"domain":["asmedigitalcollection.asme.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Vaginal delivery is typically avoided in the extremely preterm breech population due to the concern of entrapment by the cervix of the aftercoming head. A mechanical device concept is presented to enable vaginal delivery by preventing retraction of the cervix against the fetus during delivery. The two-part device was designed to dilate the cervix, prevent prolapse of small fetal parts and maintain sufficient dilation during delivery. The two-part device was designed and manufactured with the following modules: an inflatable saline-filled cervical balloon for dilation and a cervical retractor composed of semirigid beams to stabilize the cervix and maintain adequate dilation. The device was tested using a cervical phantom designed to simulate the compressive force the cervix exerts. The cervical balloon reached a maximum dilation of 8.5\u2009cm, after which there was leakage of saline from the balloon. While this dilation was less than the target goal of 10\u2009cm, the leaking was attributed to prototype manufacturing defects, which could be resolved with further development. The cervical retractor was able to withstand between 1\u20133\u2009kPa. Although estimates of cervical pressure values can be upward of 30 kPa, there are no in vivo measurements to formally identify the pressure values for patients in preterm labor. This device serves as a viable proof-of-concept for utilizing an inflatable balloon device to prevent cervical retraction in the setting of extremely preterm vaginal breech delivery. Further manufacturing improvements and design changes could improve the device for continued development and testing.<\/jats:p>","DOI":"10.1115\/1.4049086","type":"journal-article","created":{"date-parts":[[2020,11,11]],"date-time":"2020-11-11T14:45:58Z","timestamp":1605105958000},"update-policy":"https:\/\/doi.org\/10.1115\/crossmarkpolicy-asme","source":"Crossref","is-referenced-by-count":2,"title":["Device Prototype for Vaginal Delivery of Extremely Preterm Fetuses in the Breech Presentation"],"prefix":"10.1115","volume":"15","author":[{"given":"Mallory","family":"Whalen","sequence":"first","affiliation":[{"name":"Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA 02139"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Chang-Davidson","sequence":"additional","affiliation":[{"name":"Department of Mechanical Engineering,Carnegie Mellon University, Pittsburgh, PA 15213; Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA 02139"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terra","family":"Moran","sequence":"additional","affiliation":[{"name":"Master in Design Engineering Program, Harvard University, Cambridge, MA 02138"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel","family":"Hoffman","sequence":"additional","affiliation":[{"name":"Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA 02139"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Galit H.","family":"Frydman","sequence":"additional","affiliation":[{"name":"Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, MA 02139; Department of Surgery, Massachusetts General Hospital, Boston, MA 02114"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Slocum","sequence":"additional","affiliation":[{"name":"Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA 02139"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alissa","family":"Dangel","sequence":"additional","affiliation":[{"name":"TL1 Clinical Research Fellow, Tufts Medical Center\u2014CTSI, Boston, MA 02111"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"33","published-online":{"date-parts":[[2020,12,18]]},"reference":[{"edition":"3rd ed.","volume-title":"Cunningham and Gilstrap's Operative Obstetrics","year":"2017","key":"2020121803590215900_bib1"},{"issue":"2","key":"2020121803590215900_bib2","doi-asserted-by":"crossref","first-page":"65","DOI":"10.4103\/2230-8229.97050","article-title":"Preterm Singleton Breech Delivery in a Teaching Hospital of Saudi Arabia: Vaginal Versus Cesarean Delivery","volume":"15","year":"2008","journal-title":"J. Family Commun. Med."},{"first-page":"179","article-title":"Safe Prevention of the Primary Cesarean Delivery","year":"2014","key":"2020121803590215900_bib3"},{"issue":"4","key":"2020121803590215900_bib4","first-page":"633","article-title":"Maternal and Perinatal Morbidity Associated With Classic and Inverted T Cesarean Incisions","volume":"100","year":"2002","journal-title":"Obstet. Gynecol."},{"issue":"3","key":"2020121803590215900_bib5","doi-asserted-by":"crossref","first-page":"312.e1","DOI":"10.1016\/j.ajog.2016.11.1006","article-title":"Maternal Outcomes Associated With Early Preterm Cesarean Delivery","volume":"216","year":"2017","journal-title":"Am. J. Obstet. Gynecol."},{"issue":"18","key":"2020121803590215900_bib6","doi-asserted-by":"crossref","first-page":"1788","DOI":"10.3109\/14767058.2013.811226","article-title":"Uterine Incision-to-Delivery Interval and Perinatal Outcomes in Transverse Versus Vertical Incisions in Preterm Cesarean Deliveries","volume":"26","year":"2013","journal-title":"J Matern. Fetal Neonatal Med."},{"volume-title":"Management of Unintended and Abnormal Pregnancy: Comprehensive Abortion Care","year":"2009","key":"2020121803590215900_bib7"},{"article-title":"Foley Catheters","year":"2020","author":"Health Products for You","key":"2020121803590215900_bib8"},{"article-title":"Cook\u00ae Cervical Ripening Balloon With Stylet","year":"2020","author":"Cook Medical LLC","key":"2020121803590215900_bib9"},{"volume-title":"Lecture Notes on The Mechanics of Elastic Solids","year":"1987","key":"2020121803590215900_bib10"},{"issue":"8","key":"2020121803590215900_bib11","doi-asserted-by":"crossref","first-page":"e0136856","DOI":"10.1371\/journal.pone.0136856","article-title":"Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial","volume":"10","year":"2015","journal-title":"PLoS One"},{"issue":"7","key":"2020121803590215900_bib12","doi-asserted-by":"crossref","first-page":"677","DOI":"10.1115\/1.2722334","article-title":"Teaching High School Students and College Freshmen Product Development by Deterministic Design With PREP","volume":"129","year":"2007","journal-title":"ASME J. Mech. Des."},{"key":"2020121803590215900_bib13","doi-asserted-by":"crossref","first-page":"4700107","DOI":"10.1109\/JTEHM.2013.2271897","article-title":"Classroom to Clinic: Merging Education and Research to Efficiently Prototype Medical Devices","volume":"1","year":"2013","journal-title":"IEEE J. Transl. Eng. Health Med."},{"issue":"6","key":"2020121803590215900_bib14","first-page":"1025","article-title":"Extremely Preterm Vaginal Breech Delivery en Caul","volume":"99","year":"2002","journal-title":"Obstet. Gynecol."},{"issue":"2","key":"2020121803590215900_bib15","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1148\/radiology.152.2.6739822","article-title":"Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters","volume":"152","year":"1984","journal-title":"Radiology"},{"key":"2020121803590215900_bib16","unstructured":"Myers, K., 2008, \u201c An Investigation of the Structure-Function Relationship in Human Cervical Tissue,\u201d Ph.D. thesis, Massachusetts Institute of Technology, Cambridge, MA.http:\/\/hdl.handle.net\/1721.1\/44755"},{"key":"2020121803590215900_bib17","unstructured":"Paskaleva, A., 2007, \u201c Biomechanics of Cervical Function in Pregnancy: Case of Cervical Insufficiency,\u201d Ph.D. thesis, Massachusetts Institute of Technology, Cambridge, MA.http:\/\/hdl.handle.net\/1721.1\/42287"},{"issue":"1","key":"2020121803590215900_bib18","doi-asserted-by":"crossref","first-page":"104","DOI":"10.1016\/j.actbio.2007.04.009","article-title":"Mechanical and Biochemical Properties of Human Cervical Tissue","volume":"4","year":"2008","journal-title":"Acta Biomater."},{"issue":"3","key":"2020121803590215900_bib19","doi-asserted-by":"crossref","first-page":"e91121","DOI":"10.1371\/journal.pone.0091121","article-title":"Cervical Stiffness Evaluated In Vivo by Endoflip in Pregnant Women","volume":"9","year":"2014","journal-title":"PLoS One"},{"issue":"2","key":"2020121803590215900_bib20","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1007\/s00404-015-3623-3","article-title":"Experimental Comparison of Properties of Natural and Synthetic Osmotic Dilators","volume":"292","year":"2015","journal-title":"Arch. Gynecol. Obstet."},{"issue":"8","key":"2020121803590215900_bib21","doi-asserted-by":"crossref","first-page":"763","DOI":"10.1111\/j.1471-0528.1996.tb09870.x","article-title":"Head-to-Cervix Force: An Important Physiological Variable in Labour. 1. The Temporal Relation Between Head-to-Cervix Force and Intrauterine Pressure During Labour","volume":"103","year":"1996","journal-title":"BJOG: An Int. J. Obstet. Gynaecol."},{"volume-title":"Theory of Elastic Stability","year":"1970","key":"2020121803590215900_bib22"},{"volume-title":"Buckling of a Pressurized Toroidal Ring Under Uniform External Loading","year":"1967","key":"2020121803590215900_bib23"},{"article-title":"Transcervical Foley Catheter Versus Laminaria: A Randomized Controlled Trial Comparing Efficacy and Safety in Facilitating Cervical Dilatation in Cases of Molar Pregnancies*","volume-title":"Philipp. J. Obstet. Gynecol.","year":"2015","key":"2020121803590215900_bib24"}],"container-title":["Journal of Medical Devices"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/asmedigitalcollection.asme.org\/medicaldevices\/article-pdf\/doi\/10.1115\/1.4049086\/6605632\/med_015_02_021002.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/asmedigitalcollection.asme.org\/medicaldevices\/article-pdf\/doi\/10.1115\/1.4049086\/6605632\/med_015_02_021002.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,12]],"date-time":"2023-10-12T02:20:59Z","timestamp":1697077259000},"score":1,"resource":{"primary":{"URL":"https:\/\/asmedigitalcollection.asme.org\/medicaldevices\/article\/doi\/10.1115\/1.4049086\/1090632\/Device-Prototype-for-Vaginal-Delivery-of-Extremely"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,18]]},"references-count":24,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,6,1]]}},"URL":"https:\/\/doi.org\/10.1115\/1.4049086","relation":{},"ISSN":["1932-6181","1932-619X"],"issn-type":[{"type":"print","value":"1932-6181"},{"type":"electronic","value":"1932-619X"}],"subject":[],"published":{"date-parts":[[2020,12,18]]},"article-number":"021002"}}