Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-12

AUTHORS

Joan T. Price, Bellington Vwalika, Bethany L. Freeman, Stephen R. Cole, Helen B. Mulenga, Jennifer Winston, Felistas M. Mbewe, Elwyn Chomba, Lynne M. Mofenson, Dwight J. Rouse, Robert L. Goldenberg, Jeffrey S. A. Stringer

ABSTRACT

BACKGROUND: Each year, an estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries. Maternal HIV infection increases a woman's risk of delivering prematurely, and antiretroviral therapy (ART) may compound this risk. While prenatal progesterone prophylaxis prevents preterm birth among some high-risk women, it is unknown whether HIV-infected women could benefit from this therapy. We are studying the efficacy of progesterone supplementation to reduce the risk of preterm birth among pregnant women with HIV in Lusaka, Zambia. METHODS: The Improving Pregnancy Outcomes with Progesterone (IPOP) study is a Phase III double-masked, placebo-controlled, randomized trial of intramuscular 17-alpha hydroxprogesterone caproate (17P) to prevent preterm birth in HIV-infected women. A total of 800 women will be recruited prior to 24 weeks of gestation and randomly allocated to 17P or placebo administered by weekly intramuscular injection. The primary outcome will be a composite of live birth prior to 37 completed gestational weeks or stillbirth at any gestational age. Secondary outcomes will include very preterm birth (< 34 weeks), extreme preterm birth (< 28 weeks), small for gestational age (<10th centile), low birth weight (< 2500 g), and neonatal outcomes. In secondary analysis, we will assess whether specific HIV-related covariates, including the timing of maternal ART initiation relative to conception, is associated with progesterone's prophylactic efficacy, if any. DISCUSSION: We hypothesize that weekly prenatal 17P will reduce the risk of HIV-related preterm birth. An inexpensive intervention to prevent preterm birth among pregnant women with HIV could have substantial global public health impact. TRIAL REGISTRATION: NCT03297216 ; September 29, 2017. More... »

PAGES

81

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12884-019-2224-8

DOI

http://dx.doi.org/10.1186/s12884-019-2224-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112435541

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30813934


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1114", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Paediatrics and Reproductive Medicine", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "University of Zambia", 
          "id": "https://www.grid.ac/institutes/grid.12984.36", 
          "name": [
            "Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, 27599-7577, Chapel Hill, NC, USA", 
            "Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Price", 
        "givenName": "Joan T.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of Zambia", 
          "id": "https://www.grid.ac/institutes/grid.12984.36", 
          "name": [
            "Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, 27599-7577, Chapel Hill, NC, USA", 
            "Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Vwalika", 
        "givenName": "Bellington", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of North Carolina at Chapel Hill", 
          "id": "https://www.grid.ac/institutes/grid.10698.36", 
          "name": [
            "Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, 27599-7577, Chapel Hill, NC, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Freeman", 
        "givenName": "Bethany L.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of North Carolina at Chapel Hill", 
          "id": "https://www.grid.ac/institutes/grid.10698.36", 
          "name": [
            "Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Cole", 
        "givenName": "Stephen R.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "Pharmaceutical Society of Zambia, Lusaka, Zambia"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Mulenga", 
        "givenName": "Helen B.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of North Carolina at Chapel Hill", 
          "id": "https://www.grid.ac/institutes/grid.10698.36", 
          "name": [
            "Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, 27599-7577, Chapel Hill, NC, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Winston", 
        "givenName": "Jennifer", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "name": [
            "UNC Global Projects \u2013 Zambia, Lusaka, Zambia"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Mbewe", 
        "givenName": "Felistas M.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University Teaching Hospital", 
          "id": "https://www.grid.ac/institutes/grid.79746.3b", 
          "name": [
            "Department of Paediatrics, University Teaching Hospital, Lusaka, Zambia"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Chomba", 
        "givenName": "Elwyn", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Elizabeth Glaser Pediatric AIDS Foundation", 
          "id": "https://www.grid.ac/institutes/grid.420931.d", 
          "name": [
            "Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Mofenson", 
        "givenName": "Lynne M.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Brown University", 
          "id": "https://www.grid.ac/institutes/grid.40263.33", 
          "name": [
            "Department of Obstetrics and Gynecology, Brown University, Providence, RI, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Rouse", 
        "givenName": "Dwight J.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Columbia University", 
          "id": "https://www.grid.ac/institutes/grid.21729.3f", 
          "name": [
            "Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Goldenberg", 
        "givenName": "Robert L.", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of North Carolina at Chapel Hill", 
          "id": "https://www.grid.ac/institutes/grid.10698.36", 
          "name": [
            "Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, 27599-7577, Chapel Hill, NC, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Stringer", 
        "givenName": "Jeffrey S. A.", 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "https://doi.org/10.1016/j.cct.2005.01.009", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001184252"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/14651858.cd004947.pub3", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001924464"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/00002030-200012220-00013", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004185441"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/00002030-200012220-00013", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004185441"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmoa035140", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1005064298"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s2352-3018(15)00207-6", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009434683"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0140-6736(10)60496-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1010219360"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/00001648-200009000-00011", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1011053858"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/00001648-200009000-00011", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1011053858"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.ajog.2011.10.866", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1015891756"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/uog.15894", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020085218"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.ajog.2012.03.010", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1023624635"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0140-6736(12)60820-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1025793568"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/sim.3585", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1028864738"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/sim.3585", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1028864738"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s40814-016-0087-6", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1028914832", 
          "https://doi.org/10.1186/s40814-016-0087-6"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0140-6736(12)62160-6", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1030876281"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/uog.13448", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1033986905"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/ijgo.12036", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038641638"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/aje/kwn164", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041980095"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10654-012-9702-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1043194911", 
          "https://doi.org/10.1007/s10654-012-9702-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1471-0528.2010.02689.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044132795"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1471-0528.2010.02689.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044132795"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/infdis/jiv389", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1046793779"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/infdis/jis553", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1046975452"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejm199602293340904", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050486010"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1089/10430340152528174", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1059202189"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s40814-017-0170-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090746353", 
          "https://doi.org/10.1186/s40814-017-0170-7"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/s40814-017-0170-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1090746353", 
          "https://doi.org/10.1186/s40814-017-0170-7"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1001/jamapediatrics.2017.2222", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1091085327"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s2214-109x(18)30218-3", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1104380606"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s2214-109x(18)30218-3", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1104380606"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/ijgo.12686", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1107298758"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/ijgo.12686", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1107298758"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.12688/gatesopenres.12820.2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1110371688"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.12688/gatesopenres.12820.2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1110371688"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.12688/gatesopenres.12820.2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1110371688"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2019-12", 
    "datePublishedReg": "2019-12-01", 
    "description": "BACKGROUND: Each year, an estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries. Maternal HIV infection increases a woman's risk of delivering prematurely, and antiretroviral therapy (ART) may compound this risk. While prenatal progesterone prophylaxis prevents preterm birth among some high-risk women, it is unknown whether HIV-infected women could benefit from this therapy. We are studying the efficacy of progesterone supplementation to reduce the risk of preterm birth among pregnant women with HIV in Lusaka, Zambia.\nMETHODS: The Improving Pregnancy Outcomes with Progesterone (IPOP) study is a Phase III double-masked, placebo-controlled, randomized trial of intramuscular 17-alpha hydroxprogesterone caproate (17P) to prevent preterm birth in HIV-infected women. A total of 800 women will be recruited prior to 24\u2009weeks of\u00a0gestation and randomly allocated to 17P or placebo administered by weekly intramuscular injection. The primary outcome will be a composite of live birth prior to 37 completed gestational weeks or stillbirth at any gestational age. Secondary outcomes will include very preterm birth (<\u200934\u2009weeks), extreme preterm birth (<\u200928\u2009weeks), small for gestational age (<10th centile), low birth weight (<\u20092500\u2009g), and neonatal outcomes. In secondary analysis, we will assess whether specific HIV-related covariates, including the timing of maternal ART initiation relative to conception, is associated with progesterone's prophylactic efficacy, if any.\nDISCUSSION: We hypothesize that weekly prenatal 17P will reduce the risk of HIV-related preterm birth. An inexpensive intervention to prevent preterm birth among pregnant women with HIV could have substantial global public health impact.\nTRIAL REGISTRATION: NCT03297216 ; September 29, 2017.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1186/s12884-019-2224-8", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isFundedItemOf": [
      {
        "id": "sg:grant.7389837", 
        "type": "MonetaryGrant"
      }, 
      {
        "id": "sg:grant.6442679", 
        "type": "MonetaryGrant"
      }, 
      {
        "id": "sg:grant.2684521", 
        "type": "MonetaryGrant"
      }, 
      {
        "id": "sg:grant.7072245", 
        "type": "MonetaryGrant"
      }
    ], 
    "isPartOf": [
      {
        "id": "sg:journal.1024631", 
        "issn": [
          "1471-2393"
        ], 
        "name": "BMC Pregnancy and Childbirth", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "19"
      }
    ], 
    "name": "Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial", 
    "pagination": "81", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "48c59580ad131da3444fc069143fe3331b8e73f88c33a8f886e1bb82c5d0115c"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "30813934"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "100967799"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/s12884-019-2224-8"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1112435541"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/s12884-019-2224-8", 
      "https://app.dimensions.ai/details/publication/pub.1112435541"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-11T11:27", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000356_0000000356/records_57900_00000001.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://link.springer.com/10.1186%2Fs12884-019-2224-8"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/s12884-019-2224-8'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/s12884-019-2224-8'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/s12884-019-2224-8'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/s12884-019-2224-8'


 

This table displays all metadata directly associated to this object as RDF triples.

249 TRIPLES      21 PREDICATES      57 URIs      21 LITERALS      9 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/s12884-019-2224-8 schema:about anzsrc-for:11
2 anzsrc-for:1114
3 schema:author Nc60b7213c56247ff8bb74a07dadf4103
4 schema:citation sg:pub.10.1007/s10654-012-9702-x
5 sg:pub.10.1186/s40814-016-0087-6
6 sg:pub.10.1186/s40814-017-0170-7
7 https://doi.org/10.1001/jamapediatrics.2017.2222
8 https://doi.org/10.1002/14651858.cd004947.pub3
9 https://doi.org/10.1002/ijgo.12036
10 https://doi.org/10.1002/ijgo.12686
11 https://doi.org/10.1002/sim.3585
12 https://doi.org/10.1002/uog.13448
13 https://doi.org/10.1002/uog.15894
14 https://doi.org/10.1016/j.ajog.2011.10.866
15 https://doi.org/10.1016/j.ajog.2012.03.010
16 https://doi.org/10.1016/j.cct.2005.01.009
17 https://doi.org/10.1016/s0140-6736(10)60496-5
18 https://doi.org/10.1016/s0140-6736(12)60820-4
19 https://doi.org/10.1016/s0140-6736(12)62160-6
20 https://doi.org/10.1016/s2214-109x(18)30218-3
21 https://doi.org/10.1016/s2352-3018(15)00207-6
22 https://doi.org/10.1056/nejm199602293340904
23 https://doi.org/10.1056/nejmoa035140
24 https://doi.org/10.1089/10430340152528174
25 https://doi.org/10.1093/aje/kwn164
26 https://doi.org/10.1093/infdis/jis553
27 https://doi.org/10.1093/infdis/jiv389
28 https://doi.org/10.1097/00001648-200009000-00011
29 https://doi.org/10.1097/00002030-200012220-00013
30 https://doi.org/10.1111/j.1471-0528.2010.02689.x
31 https://doi.org/10.12688/gatesopenres.12820.2
32 schema:datePublished 2019-12
33 schema:datePublishedReg 2019-12-01
34 schema:description BACKGROUND: Each year, an estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries. Maternal HIV infection increases a woman's risk of delivering prematurely, and antiretroviral therapy (ART) may compound this risk. While prenatal progesterone prophylaxis prevents preterm birth among some high-risk women, it is unknown whether HIV-infected women could benefit from this therapy. We are studying the efficacy of progesterone supplementation to reduce the risk of preterm birth among pregnant women with HIV in Lusaka, Zambia. METHODS: The Improving Pregnancy Outcomes with Progesterone (IPOP) study is a Phase III double-masked, placebo-controlled, randomized trial of intramuscular 17-alpha hydroxprogesterone caproate (17P) to prevent preterm birth in HIV-infected women. A total of 800 women will be recruited prior to 24 weeks of gestation and randomly allocated to 17P or placebo administered by weekly intramuscular injection. The primary outcome will be a composite of live birth prior to 37 completed gestational weeks or stillbirth at any gestational age. Secondary outcomes will include very preterm birth (< 34 weeks), extreme preterm birth (< 28 weeks), small for gestational age (<10th centile), low birth weight (< 2500 g), and neonatal outcomes. In secondary analysis, we will assess whether specific HIV-related covariates, including the timing of maternal ART initiation relative to conception, is associated with progesterone's prophylactic efficacy, if any. DISCUSSION: We hypothesize that weekly prenatal 17P will reduce the risk of HIV-related preterm birth. An inexpensive intervention to prevent preterm birth among pregnant women with HIV could have substantial global public health impact. TRIAL REGISTRATION: NCT03297216 ; September 29, 2017.
35 schema:genre research_article
36 schema:inLanguage en
37 schema:isAccessibleForFree true
38 schema:isPartOf Na3d8cea854144334a28651e7ec1d189e
39 Nab409ddc908244f1b4fe88a3c3bc0968
40 sg:journal.1024631
41 schema:name Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial
42 schema:pagination 81
43 schema:productId N39567a23928847bdaa5f4ddcdbd86c6d
44 N465675c0d37e4455bd852b2d398a25c9
45 Nae932f7e1a804b4abc1bd3411453bccb
46 Nc256659988d4400aa44092ddad15a74e
47 Ndb92a5f303a14ab5b72a56539f7fa5bf
48 schema:sameAs https://app.dimensions.ai/details/publication/pub.1112435541
49 https://doi.org/10.1186/s12884-019-2224-8
50 schema:sdDatePublished 2019-04-11T11:27
51 schema:sdLicense https://scigraph.springernature.com/explorer/license/
52 schema:sdPublisher N22fb7544c5054c82b215203f4f39a7aa
53 schema:url https://link.springer.com/10.1186%2Fs12884-019-2224-8
54 sgo:license sg:explorer/license/
55 sgo:sdDataset articles
56 rdf:type schema:ScholarlyArticle
57 N02aa2f5189b741119050a88b4f19a1fe rdf:first Nd2c5ea39148a4a09b1b03e1e447f8cb1
58 rdf:rest Nbe93669eaa164311818e0d653354d45b
59 N0d909f6fc7a1415fbe7689efbc342cc7 schema:affiliation https://www.grid.ac/institutes/grid.10698.36
60 schema:familyName Freeman
61 schema:givenName Bethany L.
62 rdf:type schema:Person
63 N22fb7544c5054c82b215203f4f39a7aa schema:name Springer Nature - SN SciGraph project
64 rdf:type schema:Organization
65 N24e966cbb05e4ff6bd985f0c896558fb rdf:first Nd2f1d1b33d9c490c95f0a8ff5c1f2183
66 rdf:rest N25fb65273fa84d5d94527e749afb7746
67 N25fb65273fa84d5d94527e749afb7746 rdf:first N0d909f6fc7a1415fbe7689efbc342cc7
68 rdf:rest Ncb11e621c98e46069789e83ac89f68a7
69 N39567a23928847bdaa5f4ddcdbd86c6d schema:name readcube_id
70 schema:value 48c59580ad131da3444fc069143fe3331b8e73f88c33a8f886e1bb82c5d0115c
71 rdf:type schema:PropertyValue
72 N465675c0d37e4455bd852b2d398a25c9 schema:name dimensions_id
73 schema:value pub.1112435541
74 rdf:type schema:PropertyValue
75 N695a82d06e0348428949c777cb226a2c schema:affiliation https://www.grid.ac/institutes/grid.420931.d
76 schema:familyName Mofenson
77 schema:givenName Lynne M.
78 rdf:type schema:Person
79 N6b191d3e414b44de814985a38ea11a36 schema:name UNC Global Projects – Zambia, Lusaka, Zambia
80 rdf:type schema:Organization
81 N8cb6b1bb653f4bda9d4a66de26f156b7 rdf:first Nec20e77315a74eaf9af5dd8d85f1a138
82 rdf:rest Nad4ba23f9769418199f6e990b55e972c
83 N8e2dd6caa1b64b22a9d2a2b2100257a3 schema:affiliation https://www.grid.ac/institutes/grid.79746.3b
84 schema:familyName Chomba
85 schema:givenName Elwyn
86 rdf:type schema:Person
87 Na3d8cea854144334a28651e7ec1d189e schema:volumeNumber 19
88 rdf:type schema:PublicationVolume
89 Na8a83e012e61407d810a28be69c08815 schema:affiliation N6b191d3e414b44de814985a38ea11a36
90 schema:familyName Mbewe
91 schema:givenName Felistas M.
92 rdf:type schema:Person
93 Nab08abdae1b14d599e9f1625fecd36f6 schema:affiliation https://www.grid.ac/institutes/grid.12984.36
94 schema:familyName Price
95 schema:givenName Joan T.
96 rdf:type schema:Person
97 Nab409ddc908244f1b4fe88a3c3bc0968 schema:issueNumber 1
98 rdf:type schema:PublicationIssue
99 Nad4ba23f9769418199f6e990b55e972c rdf:first Nf64634b74a0e492fb6874d52e6464da6
100 rdf:rest rdf:nil
101 Nae932f7e1a804b4abc1bd3411453bccb schema:name nlm_unique_id
102 schema:value 100967799
103 rdf:type schema:PropertyValue
104 Nb290f1e586014f56bf1e32878dac92aa schema:affiliation https://www.grid.ac/institutes/grid.40263.33
105 schema:familyName Rouse
106 schema:givenName Dwight J.
107 rdf:type schema:Person
108 Nbb45aaad6af1429f8f787237238b83cb schema:name Pharmaceutical Society of Zambia, Lusaka, Zambia
109 rdf:type schema:Organization
110 Nbe93669eaa164311818e0d653354d45b rdf:first Na8a83e012e61407d810a28be69c08815
111 rdf:rest Nd398c120b9a24e2ca42063d492905e06
112 Nc256659988d4400aa44092ddad15a74e schema:name doi
113 schema:value 10.1186/s12884-019-2224-8
114 rdf:type schema:PropertyValue
115 Nc60b7213c56247ff8bb74a07dadf4103 rdf:first Nab08abdae1b14d599e9f1625fecd36f6
116 rdf:rest N24e966cbb05e4ff6bd985f0c896558fb
117 Nc97f954579564c10a44068e9208afc88 rdf:first N695a82d06e0348428949c777cb226a2c
118 rdf:rest Nea5c6914b81140eab57ea7a5052a6925
119 Ncb11e621c98e46069789e83ac89f68a7 rdf:first Ne2903b1927834d93b7224f096fd1dea3
120 rdf:rest Ne1f30e6e5b2343489db5eb2feff56b03
121 Nd2c5ea39148a4a09b1b03e1e447f8cb1 schema:affiliation https://www.grid.ac/institutes/grid.10698.36
122 schema:familyName Winston
123 schema:givenName Jennifer
124 rdf:type schema:Person
125 Nd2f1d1b33d9c490c95f0a8ff5c1f2183 schema:affiliation https://www.grid.ac/institutes/grid.12984.36
126 schema:familyName Vwalika
127 schema:givenName Bellington
128 rdf:type schema:Person
129 Nd398c120b9a24e2ca42063d492905e06 rdf:first N8e2dd6caa1b64b22a9d2a2b2100257a3
130 rdf:rest Nc97f954579564c10a44068e9208afc88
131 Ndb92a5f303a14ab5b72a56539f7fa5bf schema:name pubmed_id
132 schema:value 30813934
133 rdf:type schema:PropertyValue
134 Ne1f30e6e5b2343489db5eb2feff56b03 rdf:first Nfe115eb6afc3494abf5e524509effc78
135 rdf:rest N02aa2f5189b741119050a88b4f19a1fe
136 Ne2903b1927834d93b7224f096fd1dea3 schema:affiliation https://www.grid.ac/institutes/grid.10698.36
137 schema:familyName Cole
138 schema:givenName Stephen R.
139 rdf:type schema:Person
140 Nea5c6914b81140eab57ea7a5052a6925 rdf:first Nb290f1e586014f56bf1e32878dac92aa
141 rdf:rest N8cb6b1bb653f4bda9d4a66de26f156b7
142 Nec20e77315a74eaf9af5dd8d85f1a138 schema:affiliation https://www.grid.ac/institutes/grid.21729.3f
143 schema:familyName Goldenberg
144 schema:givenName Robert L.
145 rdf:type schema:Person
146 Nf64634b74a0e492fb6874d52e6464da6 schema:affiliation https://www.grid.ac/institutes/grid.10698.36
147 schema:familyName Stringer
148 schema:givenName Jeffrey S. A.
149 rdf:type schema:Person
150 Nfe115eb6afc3494abf5e524509effc78 schema:affiliation Nbb45aaad6af1429f8f787237238b83cb
151 schema:familyName Mulenga
152 schema:givenName Helen B.
153 rdf:type schema:Person
154 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
155 schema:name Medical and Health Sciences
156 rdf:type schema:DefinedTerm
157 anzsrc-for:1114 schema:inDefinedTermSet anzsrc-for:
158 schema:name Paediatrics and Reproductive Medicine
159 rdf:type schema:DefinedTerm
160 sg:grant.2684521 http://pending.schema.org/fundedItem sg:pub.10.1186/s12884-019-2224-8
161 rdf:type schema:MonetaryGrant
162 sg:grant.6442679 http://pending.schema.org/fundedItem sg:pub.10.1186/s12884-019-2224-8
163 rdf:type schema:MonetaryGrant
164 sg:grant.7072245 http://pending.schema.org/fundedItem sg:pub.10.1186/s12884-019-2224-8
165 rdf:type schema:MonetaryGrant
166 sg:grant.7389837 http://pending.schema.org/fundedItem sg:pub.10.1186/s12884-019-2224-8
167 rdf:type schema:MonetaryGrant
168 sg:journal.1024631 schema:issn 1471-2393
169 schema:name BMC Pregnancy and Childbirth
170 rdf:type schema:Periodical
171 sg:pub.10.1007/s10654-012-9702-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1043194911
172 https://doi.org/10.1007/s10654-012-9702-x
173 rdf:type schema:CreativeWork
174 sg:pub.10.1186/s40814-016-0087-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1028914832
175 https://doi.org/10.1186/s40814-016-0087-6
176 rdf:type schema:CreativeWork
177 sg:pub.10.1186/s40814-017-0170-7 schema:sameAs https://app.dimensions.ai/details/publication/pub.1090746353
178 https://doi.org/10.1186/s40814-017-0170-7
179 rdf:type schema:CreativeWork
180 https://doi.org/10.1001/jamapediatrics.2017.2222 schema:sameAs https://app.dimensions.ai/details/publication/pub.1091085327
181 rdf:type schema:CreativeWork
182 https://doi.org/10.1002/14651858.cd004947.pub3 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001924464
183 rdf:type schema:CreativeWork
184 https://doi.org/10.1002/ijgo.12036 schema:sameAs https://app.dimensions.ai/details/publication/pub.1038641638
185 rdf:type schema:CreativeWork
186 https://doi.org/10.1002/ijgo.12686 schema:sameAs https://app.dimensions.ai/details/publication/pub.1107298758
187 rdf:type schema:CreativeWork
188 https://doi.org/10.1002/sim.3585 schema:sameAs https://app.dimensions.ai/details/publication/pub.1028864738
189 rdf:type schema:CreativeWork
190 https://doi.org/10.1002/uog.13448 schema:sameAs https://app.dimensions.ai/details/publication/pub.1033986905
191 rdf:type schema:CreativeWork
192 https://doi.org/10.1002/uog.15894 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020085218
193 rdf:type schema:CreativeWork
194 https://doi.org/10.1016/j.ajog.2011.10.866 schema:sameAs https://app.dimensions.ai/details/publication/pub.1015891756
195 rdf:type schema:CreativeWork
196 https://doi.org/10.1016/j.ajog.2012.03.010 schema:sameAs https://app.dimensions.ai/details/publication/pub.1023624635
197 rdf:type schema:CreativeWork
198 https://doi.org/10.1016/j.cct.2005.01.009 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001184252
199 rdf:type schema:CreativeWork
200 https://doi.org/10.1016/s0140-6736(10)60496-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1010219360
201 rdf:type schema:CreativeWork
202 https://doi.org/10.1016/s0140-6736(12)60820-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1025793568
203 rdf:type schema:CreativeWork
204 https://doi.org/10.1016/s0140-6736(12)62160-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1030876281
205 rdf:type schema:CreativeWork
206 https://doi.org/10.1016/s2214-109x(18)30218-3 schema:sameAs https://app.dimensions.ai/details/publication/pub.1104380606
207 rdf:type schema:CreativeWork
208 https://doi.org/10.1016/s2352-3018(15)00207-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009434683
209 rdf:type schema:CreativeWork
210 https://doi.org/10.1056/nejm199602293340904 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050486010
211 rdf:type schema:CreativeWork
212 https://doi.org/10.1056/nejmoa035140 schema:sameAs https://app.dimensions.ai/details/publication/pub.1005064298
213 rdf:type schema:CreativeWork
214 https://doi.org/10.1089/10430340152528174 schema:sameAs https://app.dimensions.ai/details/publication/pub.1059202189
215 rdf:type schema:CreativeWork
216 https://doi.org/10.1093/aje/kwn164 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041980095
217 rdf:type schema:CreativeWork
218 https://doi.org/10.1093/infdis/jis553 schema:sameAs https://app.dimensions.ai/details/publication/pub.1046975452
219 rdf:type schema:CreativeWork
220 https://doi.org/10.1093/infdis/jiv389 schema:sameAs https://app.dimensions.ai/details/publication/pub.1046793779
221 rdf:type schema:CreativeWork
222 https://doi.org/10.1097/00001648-200009000-00011 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011053858
223 rdf:type schema:CreativeWork
224 https://doi.org/10.1097/00002030-200012220-00013 schema:sameAs https://app.dimensions.ai/details/publication/pub.1004185441
225 rdf:type schema:CreativeWork
226 https://doi.org/10.1111/j.1471-0528.2010.02689.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1044132795
227 rdf:type schema:CreativeWork
228 https://doi.org/10.12688/gatesopenres.12820.2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1110371688
229 rdf:type schema:CreativeWork
230 https://www.grid.ac/institutes/grid.10698.36 schema:alternateName University of North Carolina at Chapel Hill
231 schema:name Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
232 Division of Global Women’s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, 27599-7577, Chapel Hill, NC, USA
233 rdf:type schema:Organization
234 https://www.grid.ac/institutes/grid.12984.36 schema:alternateName University of Zambia
235 schema:name Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia
236 Division of Global Women’s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3009 Old Clinic Building, Campus Box 7577, 27599-7577, Chapel Hill, NC, USA
237 rdf:type schema:Organization
238 https://www.grid.ac/institutes/grid.21729.3f schema:alternateName Columbia University
239 schema:name Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA
240 rdf:type schema:Organization
241 https://www.grid.ac/institutes/grid.40263.33 schema:alternateName Brown University
242 schema:name Department of Obstetrics and Gynecology, Brown University, Providence, RI, USA
243 rdf:type schema:Organization
244 https://www.grid.ac/institutes/grid.420931.d schema:alternateName Elizabeth Glaser Pediatric AIDS Foundation
245 schema:name Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA
246 rdf:type schema:Organization
247 https://www.grid.ac/institutes/grid.79746.3b schema:alternateName University Teaching Hospital
248 schema:name Department of Paediatrics, University Teaching Hospital, Lusaka, Zambia
249 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...