{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:11:21Z","timestamp":1772169081895,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/gatesopenres.13716.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T00:00:00Z","timestamp":1671408000000}}],"reference-count":33,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T00:00:00Z","timestamp":1671408000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1192462"],"award-info":[{"award-number":["OPP1192462"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["K01TW010857"],"award-info":[{"award-number":["K01TW010857"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["T32HD075731"],"award-info":[{"award-number":["T32HD075731"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["D43TW009340"],"award-info":[{"award-number":["D43TW009340"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["gatesopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Gates Open Res"],"abstract":"<ns4:p>\n                    <ns4:bold>Background:<\/ns4:bold>\n                    Each year, nearly 300,000 women and 5 million fetuses or neonates die during childbirth or shortly thereafter, a burden concentrated disproportionately in low- and middle-income countries. Identifying women and their fetuses at risk for intrapartum-related morbidity and death could facilitate early intervention.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Methods:<\/ns4:bold>\n                    The Limiting Adverse Birth Outcomes in Resource-Limited Settings (LABOR) Study is a multi-country, prospective, observational cohort designed to exhaustively document the course and outcomes of labor, delivery, and the immediate postpartum period in settings where adverse outcomes are frequent. The study is conducted at four hospitals across three countries in Ghana, India, and Zambia. We will enroll approximately 12,000 women at presentation to the hospital for delivery and follow them and their fetuses\/newborns throughout their labor and delivery course, postpartum hospitalization, and up to 42 days thereafter. The co-primary outcomes are composites of maternal (death, hemorrhage, hypertensive disorders, infection) and fetal\/neonatal adverse events (death, encephalopathy, sepsis) that may be attributed to the intrapartum period. The study collects extensive physiologic data through the use of physiologic sensors and employs medical scribes to document examination findings, diagnoses, medications, and other interventions in real time.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Discussion:<\/ns4:bold>\n                    The goal of this research is to produce a large, sharable dataset that can be used to build statistical algorithms to prospectively stratify parturients according to their risk of adverse outcomes. We anticipate this research will inform the development of new tools to reduce peripartum morbidity and mortality in low-resource settings.\n                  <\/ns4:p>","DOI":"10.12688\/gatesopenres.13716.2","type":"journal-article","created":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T05:30:07Z","timestamp":1671427807000},"page":"115","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Limiting adverse birth outcomes in resource-limited settings (LABOR): protocol of a prospective intrapartum cohort study"],"prefix":"10.12688","volume":"6","author":[{"given":"Amanda","family":"Adu-Amankwah","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mrutunjaya B.","family":"Bellad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aimee M.","family":"Benson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Titus K.","family":"Beyuo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manisha","family":"Bhandankar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Umesh","family":"Charanthimath","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maureen","family":"Chisembele","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen R.","family":"Cole","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9575-5251","authenticated-orcid":false,"given":"Sangappa M.","family":"Dhaded","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christabel","family":"Enweronu-Laryea","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5419-6000","authenticated-orcid":false,"given":"Bethany L.","family":"Freeman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikki L. 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,6]],"date-time":"2023-01-06T08:20:11Z","timestamp":1672993211000},"score":1,"resource":{"primary":{"URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,19]]},"references-count":33,"URL":"https:\/\/doi.org\/10.12688\/gatesopenres.13716.2","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/gatesopenres.15569.r32809","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/gatesopenres.15569.r32809","asserted-by":"object"}]},"ISSN":["2572-4754"],"issn-type":[{"value":"2572-4754","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,19]]},"assertion":[{"value":"Indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/gatesopenres.15003.r32416, G. Justus Hofmeyr, Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand and Walter Sisulu, East London, South Africa, 06 Sep 2022, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v1#referee-response-32416","order":0,"name":"referee-response-32416","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Joan Price<\/b>; \n<i>Posted: 05 Dec 2022<\/i>; Thank you for your careful review and for approving our manuscript for publication. Please see point-by-point responses to your questions and comments below.  \n<b>What clinical fetal monitoring unblinded to caregivers has been employed?<\/b> Standard-of-care fetal monitoring at each of our four sites relies on intermittent monitoring by fetoscope or by handheld Doppler. Periodically, high-risk cases are monitored by continuous monitoring primarily at the Belgaum site. Study sensors were not intended for clinical care, so no sensor data was provided to caregivers in real time. See revised manuscript \u201csensor placement\u201d page 6. &nbsp; \n<b>Has information been collected on the presence of childbirth companions, which may impact several of the outcomes being measured, such as low Apgar scores?<\/b> We did not collect this information, but anecdotally childbirth companions are rarely present at any of the study sites. &nbsp; \n<b>Has information been collected on maternal position, particularly the supine position during the second stage of labour, and will it be possible to relate maternal position to the physiological data collected (or to impute maternal position from the data provided by the sensors)?<\/b> We do collect information on maternal position (and position changes). We plan to validate positional data from the maternal sensors using real-time data collected by scribes at the bedside. See revised section on \u201csensor placement\u201d page 6. &nbsp; \n<b>Were partographs used for guiding labor management, and if so which design of partograph?<\/b> Yes, partographs are regularly used to guide labor management at each site. At all four study sites, the modified WHO partograph is used. The most recent WHO Labour Care Guide has not yet been implemented at any of the study sites. &nbsp; \n<b>Were clinical management protocols in use? If so, some information on the protocols would be useful.<\/b> Clinical care at each site is guided by clinical protocols and algorithms for the management of various conditions such as hypertension, preeclampsia, antepartum hemorrhage, postpartum hemorrhage, etc. Our study scribes document care received (i.e., actions, diagnoses, medications) in real time, but do not assess providers\u2019 adherence to or variance from established clinical management protocols per se. We plan to investigate both variations in care between sites and variance from established protocols in future manuscripts, but think that a description of the various protocols at 4 different sites is beyond the scope of this protocol paper.  \n<b>It would be useful to update certain statements, for example, whether recruitment, which is due to have been completed, has indeed been completed, and whether certain proposed changes in the technology available did in fact take place.<\/b> As we write, recruitment has indeed concluded, and we transitioned from Meridian to wireless Sibel fetal sensors as planned. These statements have been updated in the revised manuscript on pages 6 and 13.  \n<b>Study participants: the phrase: &quot;3) admission to hospital labor and delivery unit with plan for either (a) vaginal delivery or (b) cesarean delivery in the presence of signs\/symptoms of parturition, elevated blood pressure, or fever;&quot; is not very clear - perhaps it could be written more precisely.<\/b> This is the eligibility criterion as written verbatim in the protocol. We have clarified this further in the manuscript.","URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v2#referee-comment-3584","order":1,"name":"referee-comment-3584","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.15569.r32809, Soo Downe, THRIVE Centre, School of Community Health and Midwifery, University of Central Lancashire, Preston, UK, 06 Jan 2023, version 2, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/6-115\/v2#referee-response-32809","order":2,"name":"referee-response-32809","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"The LABOR Study is funded by a grant from the Bill and Melinda Gates Foundation (OPP1192462). Additional support was provided by the US National Institutes of Health for JTP (K01 TW010857) and MBS (T32 HD075731; D43 TW009340). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}