Your browser doesn't support javascript.
loading
Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea.
Riddell, Michaela A; Vallely, Lisa M; Mengi, Alice; Badman, Steven G; Low, Nicola; Wand, Handan; Bolnga, John W; Babona, Delly; Mola, Glen D L; Wiseman, Virginia; Kelly-Hanku, Angela; Homer, Caroline S E; Morgan, Christopher; Luchters, Stanley; Whiley, David M; Robinson, Leanne J; Au, Lucy; Pukai-Gani, Irene; Laman, Moses; Kariwiga, Grace; Toliman, Pamela J; Batura, Neha; Tabrizi, Sepehr N; Rogerson, Stephen J; Garland, Suzanne M; Guy, Rebecca J; Peeling, Rosanna W; Pomat, William S; Kaldor, John M; Vallely, Andrew J B.
Affiliation
  • Riddell MA; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Vallely LM; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Mengi A; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
  • Badman SG; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Low N; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
  • Wand H; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Bolnga JW; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; Modilon General Hospital, Madang, Papua New Guinea.
  • Babona D; St Mary's Hospital Vunapope, Kokopo, Papua New Guinea.
  • Mola GDL; School of Medicine and Health Sciences, University of Papua New Guinea, National Capital District, Papua New Guinea.
  • Wiseman V; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia; London School of Hygiene & Tropical Medicine, London, UK.
  • Kelly-Hanku A; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Homer CSE; Burnet Institute, Melbourne, VIC, Australia.
  • Morgan C; Burnet Institute, Melbourne, VIC, Australia; Jhpiego the Johns Hopkins University affiliate, Baltimore, MD, USA.
  • Luchters S; Centre for Sexual Health and HIV/AIDS Research, Harare, Zimbabwe; Liverpool School of Tropical Medicine, Liverpool, UK.
  • Whiley DM; UQ Centre for Clinical Research, University of Queensland, Herston, QLD, Australia; Pathology Queensland Central Laboratory, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
  • Robinson LJ; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; Burnet Institute, Melbourne, VIC, Australia.
  • Au L; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
  • Pukai-Gani I; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
  • Laman M; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
  • Kariwiga G; Alotau Provincial Hospital, Alotau, Milne Bay Province, Papua New Guinea.
  • Toliman PJ; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Batura N; University College London Institute for Global Health, London, UK.
  • Tabrizi SN; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, VIC, Australia; Centre for Women's Infectious Diseases Research, The Royal Women's Hospital Melbourne, VIC, Australia.
  • Rogerson SJ; Department of Infectious Diseases, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.
  • Garland SM; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, VIC, Australia; Centre for Women's Infectious Diseases Research, The Royal Women's Hospital Melbourne, VIC, Australia.
  • Guy RJ; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Peeling RW; London School of Hygiene & Tropical Medicine, London, UK.
  • Pomat WS; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Kaldor JM; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia.
  • Vallely AJB; Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; The Kirby Institute, University of New South Wales Sydney, Kensington, NSW, Australia. Electronic address: avallely@kirby.unsw.edu.au.
Lancet Glob Health ; 12(4): e641-e651, 2024 Apr.
Article in En | MEDLINE | ID: mdl-38485431
ABSTRACT

BACKGROUND:

Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis have been associated with adverse maternal and perinatal outcomes, but there is conflicting evidence on the benefits of antenatal screening and treatment for these conditions. We aimed to determine the effect of antenatal point-of-care testing and immediate treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis on preterm birth, low birthweight, and other adverse maternal and perinatal outcomes compared with current standard of care, which included symptom-based treatment without laboratory confirmation.

METHODS:

In this pragmatic cluster randomised crossover trial, we enrolled women (aged ≥16 years) attending an antenatal clinic at 26 weeks' gestation or earlier (confirmed by obstetric ultrasound), living within approximately 1 h drive of a study clinic, and able to provide reliable contact details at ten primary health facilities and their catchment communities (clusters) in Papua New Guinea. Clusters were randomly allocated 11 to receive either the intervention or control (standard care) in the first phase of the trial. Following an interval (washout period) of 2-3 months at the end of the first phase, each cluster crossed over to the other group. Randomisation was stratified by province. Individual participants were informed about trial group allocation only after completing informed consent procedures. The primary outcome was a composite of preterm birth (livebirth before 37 weeks' gestation), low birthweight (<2500 g), or both, analysed according to the intention-to-treat population. This study is registered with ISRCTN Registry, ISRCTN37134032, and is completed.

FINDINGS:

Between July 26, 2017, and Aug 30, 2021, 4526 women were enrolled (2210 [63·3%] of 3492 women in the intervention group and 2316 [62·8%] of 3687 in the control group). Primary outcome data were available for 4297 (94·9%) newborn babies of 4526 women. The proportion of preterm birth, low birthweight, or both, in the intervention group, expressed as the mean of crude proportions across clusters, was 18·8% (SD 4·7%) compared with 17·8% in the control group (risk ratio [RR] 1·06, 95% CI 0·78-1·42; p=0·67). There were 1052 serious adverse events reported (566 in the intervention group and 486 in the control group) among 929 trial participants, and no differences by trial group.

INTERPRETATION:

Point-of-care testing and treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis did not reduce preterm birth or low birthweight compared with standard care. Within the subgroup of women with N gonorrhoeae, there was a substantial reduction in the primary outcome.

FUNDING:

UK Department of Health and Social Care; UK Foreign, Commonwealth and Development Office; UK Medical Research Council; the Wellcome Trust; the Australian National Health and Medical Research Council; and Swiss National Science Foundation.
Subject(s)
Fulltext
Print
XML
PubMed Links
Search on Google

Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 4_TD Database: MEDLINE Main subject: Urinary Tract Infections / Vaginosis, Bacterial / Premature Birth Limits: Adolescent / Adult / Female / Humans / Newborn / Pregnancy Language: En Journal: Lancet Glob Health Year: 2024 Document type: Article
Fulltext
Print
XML
PubMed Links
Search on Google

Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 4_TD Database: MEDLINE Main subject: Urinary Tract Infections / Vaginosis, Bacterial / Premature Birth Limits: Adolescent / Adult / Female / Humans / Newborn / Pregnancy Language: En Journal: Lancet Glob Health Year: 2024 Document type: Article