{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:09:23Z","timestamp":1772168963833,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/gatesopenres.12820.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2018,12,4]],"date-time":"2018-12-04T00:00:00Z","timestamp":1543881600000}}],"reference-count":33,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2018,12,4]],"date-time":"2018-12-04T00:00:00Z","timestamp":1543881600000},"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":["OPP1033514"],"award-info":[{"award-number":["OPP1033514"]}],"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":["P30AI50410"],"award-info":[{"award-number":["P30AI50410"]}],"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":["K24AI120796"],"award-info":[{"award-number":["K24AI120796"]}],"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"}]},{"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":["K01TW010857"],"award-info":[{"award-number":["K01TW010857"]}],"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                    Sub-Saharan Africa bears a disproportionate burden of preterm birth and other adverse outcomes. A better understanding of the demographic, clinical, and biologic underpinnings of these adverse outcomes is urgently needed to plan interventions and inform new discovery.\u00a0\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Methods:<\/ns4:bold>\n                    The Zambian Preterm Birth Prevention Study (ZAPPS) is a prospective observational cohort established at the Women and Newborn Hospital (WNH) in Lusaka, Zambia. We recruit pregnant women from district health centers and the WNH and offer ultrasound examination to determine eligibility. Participants receive routine obstetrical care, lab testing, midtrimester cervical length measurement, and serial fetal growth monitoring. At delivery, we assess gestational age, birthweight, vital status, and sex and assign a delivery phenotype. We collect blood, urine, and vaginal swab specimens at scheduled visits and store them in an on-site biorepository.\u00a0In September 2017, enrollment of the ZAPPS Phase 1 \u2013 the subject of this report \u2013 was completed. Phase 2 \u2013 which is limited to HIV-uninfected women \u2013 reopened in January 2018.\u00a0\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Results:<\/ns4:bold>\n                    Between August 2015 and September 2017, we screened 1784 women, of whom 1450 (81.2%) met inclusion criteria and were enrolled. The median age at enrollment was 27 years (IQR 23\u201332) and thee median gestational age was 16 weeks (IQR 13\u201318). Among parous women (N=866; 64%), 21% (N=182) reported a prior miscarriage, 49% (N=424) reported a prior preterm birth, and 13% (N=116) reported a prior stillbirth. The HIV seroprevalence was 24%.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Discussion:<\/ns4:bold>\n                    We have established a large cohort of pregnant women and newborns at the WHN to characterize the determinants of adverse birth outcomes in Lusaka, Zambia. Our overarching goal is to elucidate biological mechanisms in an effort to identify new strategies for early detection and prevention of adverse outcomes. We hope that findings from this cohort will help guide future studies, clinical care, and policy.\n                  <\/ns4:p>","DOI":"10.12688\/gatesopenres.12820.2","type":"journal-article","created":{"date-parts":[[2018,12,4]],"date-time":"2018-12-04T11:25:29Z","timestamp":1543922729000},"page":"25","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["The Zambian Preterm Birth Prevention Study (ZAPPS): Cohort characteristics at enrollment"],"prefix":"10.12688","volume":"2","author":[{"given":"Marcela C.","family":"Castillo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nurain M.","family":"Fuseini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katelyn","family":"Rittenhouse","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joan T.","family":"Price","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":"Humphrey","family":"Mwape","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Winston","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8494-4735","authenticated-orcid":false,"given":"Ntazana","family":"Sindano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Courtney","family":"Baruch-Gravett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1435-8455","authenticated-orcid":false,"given":"Benjamin H.","family":"Chi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7285-998X","authenticated-orcid":false,"given":"Margaret P.","family":"Kasaro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James A.","family":"Litch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9590-7216","authenticated-orcid":false,"given":"Jeffrey S. A.","family":"Stringer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bellington","family":"Vwalika","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2018,12,4]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"2162-2172","DOI":"10.1016\/S0140-6736(12)60820-4","article-title":"National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications.","volume":"379","author":"H Blencowe","year":"2012","journal-title":"Lancet."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"82-90","DOI":"10.1056\/NEJM198501103120204","article-title":"The contribution of low birth weight to infant mortality and childhood morbidity.","volume":"312","author":"M McCormick","year":"1985","journal-title":"N Engl J 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Stringer","year":"2018","journal-title":"Open Science Framework."}],"updated-by":[{"DOI":"10.12688\/gatesopenres.12820.3","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2019,7,15]],"date-time":"2019-07-15T00:00:00Z","timestamp":1563148800000}}],"container-title":["Gates Open 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status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/gatesopenres.13888.r26410, Zahida Qureshi, Department of Obstetrics and Gynaecology, School of Medicine, University of Nairobi, Nairobi, Kenya, 24 May 2018, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/gatesopenresearch.org\/articles\/2-25\/v1#referee-response-26410","order":0,"name":"referee-response-26410","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Jeffrey S. A. Stringer<\/b>; \n<i>Posted: 12 Nov 2018<\/i>; \n<b>Zahida Qureshi<\/b>,&nbsp;Department of Obstetrics and Gynaecology, School of Medicine, University of Nairobi, Nairobi, Kenya&nbsp;\n<b>Approved<\/b>&nbsp;Thank you for giving me the opportunity to review the research article entitled \u201cThe Zambian Preterm Birth Prevention Study (ZAPPS: Cohort characteristics at enrollment)\u201d&nbsp;Overall the study is important to understand the dynamics of preterm birth in a sub-saharan developing country, with intent to plan interventions.&nbsp;I have the following comments: -\n<b>Abstract:<\/b>Methods \u2013 should read as \u2018the Zambian Preterm Birth Prevention study (ZAPPS) is an observational study, of a prospective antenatal cohort \u2026\u2026\u2026.\u2019\n<i>This suggested edit has been made (line 10).<\/i>\n<b>Results-<\/b>this cohort is 1450 participants and is not clear is this the entire cohort or a subset as the protocol mentions the enrollment to be estimated at 4000, so is recruitment still ongoing? This needs to be clarified.&nbsp;\n<i>Recruitment is indeed ongoing, but under a slightly revised protocol. This is a description of the cohort established under the original protocol only. The original estimated enrollment of 4000 has been amended to 2000 on the ClinicalTrials.gov website.<\/i>\n<b>Discussion<\/b>\u2013 also add the primary objective of the ZAPPS study, as stated below\n<i>Our primary objective in the protocol reads as follows: \u201cto establish a cohort of 2,000 pregnant women and their infants, following them through delivery and up to 42 days postpartum.\u201d We have revised the language in the Discussion of the abstract to reflect that original wording (lines 31-32).&nbsp;<\/i>\n<b>Page 3&nbsp;<\/b>Primary objective \u2013 should also include the primary objective of the study as stated in the protocol&nbsp;&nbsp;\n<i>Our primary objective in the protocol reads as follows: \u201cto establish a cohort of 2,000 pregnant women and their infants, following them through delivery and up to 42 days postpartum. We will recruit and enroll 2,000 women and their newborn infants in Zambia.\u201d We have revised the language in our \u201cPrimary objective\u201d section to reflect this wording (lines 106-110).&nbsp;<\/i>Primary outcome measure \u2013 Rate of preterm births per 100 person years, incidence rate of preterm birth (delivery &lt;37 weeks\u2019 gestation)\n<i>Thank you for noting this inconsistency. The primary outcome as stated in the most recent protocol is as follows:&nbsp;<\/i>\n<i>\u201cThe primary outcome is preterm birth, defined as birth prior to 37 weeks completed gestation. The secondary outcomes are (1) delivery prior to 34 weeks completed gestation and (2) low birth weight, defined as less than 2500 grams.\u201d<\/i>\n<i>We have added an \u201cOutcomes\u201d section to the Methods of this paper to address this omission (lines 111-118).<\/i>\n<b>Page 4 Clinical care and follow up<\/b>It is stated that after enrollment women return for cervical length evaluation between 20 and 24 weeks and those with a short cervix have additional visits at 28 and 32- in table 1 the ultrasound is at 34 and not 32 weeks. It is important to mention if this is standard of care for all patients at this site or only for those with previous preterm birth. Page 6 mentions that this is a non-interventional study.\n<i>We have revised the text to the following: \u201cAfter enrollment, all participants return for universal cervical length evaluation between 20 and 24 weeks\u2019 gestation. Those with a short cervix by transvaginal ultrasound, defined as &lt;2.5 cm, then attend additional visits scheduled at 28 and 32 weeks\u2019 gestation for repeat cervical length ultrasounds and are referred to a study physician at the UTH for further counseling and follow-up\u201d (lines 135-139). The additional visits at 28 and 34 weeks\u2019 for cervical length ultrasound are only for those women with short cervix. This is explained also in the footnote to Table 1. Biometry ultrasound at 32 weeks is performed for all participants.&nbsp;<\/i>&nbsp;No mention is made of the maternal depression screen at 24 and 42 weeks.\n<i>Thank you for pointing this out. The following sentence has been added to the section on Clinical care &amp; follow-up:<\/i>\n<i>\u201cThe Edinburgh Postnatal Depression Screen is self-administered by participants at 24 weeks and again at the postpartum visit. Participants who screen positive are referred to outpatient psychiatric care\u201d (lines 157-159). In addition, \u201cMaternal depression screen\u201d appears in Table 1 at 24 weeks and 42 days postpartum.<\/i>&nbsp;\n<b>Page 4 Biological specimen collection&nbsp;<\/b>Study nurses collected maternal specimens at enrollment \u2013and these were point of care tests for HIV, anemia, syphilis and UTI.The results section has a reasonably large number of missing information on some of the parameters.&nbsp;\n<i>Since our study is integrated with routine care at the clinical sites, for several cases\u2014particularly in the early conduct of the study\u2014we did not repeat routine tests previously performed at government clinics and failed to document these results on our study forms. This is a limitation of the study that we have described in our Discussion (lines 295-299). We also note that it has been rectified in Phase 2 of the cohort (line 299).<\/i>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;\n<b>Page 5 table 1&nbsp;<\/b>What were the vaginal and rectal swab tests for?\n<i>Vaginal and rectal swabs are collected for specimen storage for future protocol-related testing. No real-time tests are currently being performed on these swabs. We have clarified this in Table 1.<\/i>\n<b>Page 6&nbsp;Results section&nbsp;<\/b>Table 2-&nbsp; the missing numbers of participates with data on Syphilis is 107, Haemoglobin at enrollment 424 and malaria is 302, this needs to be explained by the authors. Patients with malaria, low haemoglobin and syphilis are at risk for preterm birth, so missing data will influence results for the ZAPPS study.&nbsp;This should be discussed by the authors as a study limitation if these figures are correct.\n<i>These figures are correct. As we note above, since our study is integrated with routine care at the clinical sites, for several cases\u2014particularly in the early conduct of the study\u2014we did not repeat routine tests previously performed at government clinics and failed to document these results on our study forms. This is a limitation of the study that we have described in our Discussion (lines 295-299). We also note that it has been rectified in Phase 2 of the cohort (line 299).<\/i>&nbsp;This comment does not influence this paper as it for those recruited up to Sept 2017. Of note is that the protocol for ZAPPS has been amended in Feb 2018 to exclude women with HIV. So eventually will there be separate analysis for the women who are included in this manuscript vs those recruited later?\n<i>That is correct. Given the amended protocol has revised key inclusion \/ exclusion criteria, the next phase of the ZAPPS cohort has not been described in this baseline manuscript. We have added an explicit description of the two phases of the ZAPPS cohort in the Methods section (lines 102-104).<\/i>","URL":"https:\/\/gatesopenresearch.org\/articles\/2-25\/v2#referee-comment-3140","order":1,"name":"referee-comment-3140","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.13986.r26804, Fyezah Jehan, Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan, 03 Jan 2019, version 2, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/2-25\/v2#referee-response-26804","order":2,"name":"referee-response-26804","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Bill and Melinda Gates Foundation grant to the Global Alliance to Prevent Prematurity and Stillbirth (Seattle Children\u2019s Hospital\/GAPPS 13008\/OPP1033514). \nAdditional support was provided by the US National Institutes of Health through the UNC Center for AIDS Research (P30 AI50410) and trainee \/ mentor support: T32 HD075731 (MCC, NMF, JTP), K01 TW010857 (JTP), D43 TW009340 (KR), and K24 AI120796 (BHC). 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"}]}}