Effect on birth outcomes of a formalised approach to care in hospital labour assessment units: international, randomised controlled trialBMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a1021 (Published 28 August 2008) Cite this as: BMJ 2008;337:a1021
- Ellen D Hodnett, professor1,
- Robyn Stremler, assistant professor12,
- Andrew R Willan, senior scientist23,
- Julie A Weston, senior trial coordinator1,
- Nancy K Lowe, professor4,
- Kathleen R Simpson, clinical nurse specialist5,
- William D Fraser, professor6,
- Amiram Gafni, professor7
- the SELAN (Structured Early Labour Assessment and Care by Nurses) Trial Group
- 1Lawrence S Bloomberg Faculty of Nursing, University of Toronto, 155 College St, Toronto, ON, Canada, M5T 1P8
- 2Program in Child Health Evaluative Sciences, and Research Institute at SickKids, SickKids Hospital, Toronto, Canada
- 3Dalla Lana School of Public Health, University of Toronto, 155 College St, Toronto, ON, Canada, M5T 3M7
- 4University of Colorado Health Sciences Center, School of Nursing, Denver, CO, USA
- 5Labor and Delivery, St John’s Mercy Medical Center, St Louis, MO, USA
- 6Université de Montréal, Département d’obstétrique-gynécologie, Pavillon Roger-Gaudry, Montréal, QC, Canada
- 7Department of Clinical Epidemiology and Biostatistics, and Centre for Health Economics and Policy Evaluation, McMaster University, Hamilton, ON, Canada
- Correspondence to: E D Hodnett
- Accepted 27 June 2008
Objective To determine if a complex nursing and midwifery intervention in hospital labour assessment units would increase the likelihood of spontaneous vaginal birth and improve other maternal and neonatal outcomes.
Design Multicentre, randomised controlled trial with prognostic stratification by hospital.
Setting 20 North American and UK hospitals.
Participants 5002 nulliparous women experiencing contractions but not in active labour; 2501 were allocated to structured care and 2501 to usual care.
Interventions Usual nursing or midwifery care or a minimum of one hour of care by a nurse or midwife trained in structured care, consisting of a formalised approach to assessment of and interventions for maternal emotional state, pain, and fetal position.
Main outcome measures Primary outcome was spontaneous vaginal birth. Other outcomes included intrapartum interventions, women’s views of their care, and indicators of maternal and fetal health during hospital stay and 6-8 weeks after discharge.
Results Outcome data were obtained for 4996 women. The rate of spontaneous vaginal birth was 64.0% (n=1597) in the structured care group and 61.3% (n=1533) in the usual care group (odds ratio 1.12, 95% confidence interval 0.96 to 1.27). Fewer women allocated to structured care (n=403, 19.5%) rated staff helpfulness as less than very helpful than those allocated to usual care (n=544, 26.4%); odds ratio 0.67, 98.75% confidence interval 0.50 to 0.85. Fewer women allocated to structured care (n=233, 11.3%) were disappointed with the amount of attention received from staff than those allocated to usual care (n=407, 19.7%); odds ratio 0.51, 98.75% confidence interval 0.32 to 0.70. None of the other results met prespecified levels of statistical significance.
Conclusion A structured approach to care in hospital labour assessment units increased satisfaction with care and was suggestive of a modest increase in the likelihood of spontaneous vaginal birth. Further study to strengthen the intervention is warranted.
Trial registration Current Controlled Trials ISRCTN16315180.
We thank the participants, staff at the participating hospitals, and the structured care trainers (Melrose East, Adele Hood, Debbie Kaye, Debbie Patrick, Anne Simmonds, Ann Sprague, and Marie-Josée Trépanier); members of the Data Safety Monitoring Committee—Rona McCandlish (chair), Shoo Lee, and David Young; members of the Structured Early Labour Assessment and Care by Nurses Trial Group who enrolled participants and collected data—Paula Baker, Amy Hailey, Charlotte Ice, Karen Langston, and Gina Smith (Harris Methodist Fort Worth Hospital, Fort Worth, TX), Nancy Fehr, Lynn Hickey, and Maggie Quance (Foothills Medical Centre, Calgary, AB), Susan Caffrey, Cheryl Hardy, Maggie Hickey, Carol Luppi, and Ginny Silva (Brigham and Women’s Hospital, Boston, MA), Judy Claringbold, Jill Fairbairn, Linda McCabe, and Janice McVeety (Ottawa Hospital—Civic Campus, Ottawa, ON), Heather Brown, Jackie Clark, Una Dewtie, Ruth Jordan, Patsy Smith, and Erna Snelgrove (IWK Health Centre, Halifax, NS), Gerry Ashton, Isabelle Baribeau, Janet Britnell, Janet Brownlee, Brenda Cook, Isabelle Gagnon, Adriana Hoselton, Nicole Joly, Debbie Kaye, Ann Salvador, and Julia Watson-Blasioli (Ottawa Hospital—General Campus, Ottawa, ON), Anne Fowler, Lucy Gilmore, Althea Stewart, Debbie Walker, and Linda Young (William Osler Health Centre, Brampton, ON), Luisa Ciofani, Helen Doulos, Francine Martin, Beatrice Stoklas, and Jennifer Supino (McGill University Health Centre, Montreal, QC), Jeannine Alt, Mary Knapp, Sandy Lynne, Denice O’Connor, and Becky VanLaan (Spectrum Health, Grand Rapids, MI), Tania Hansen, Judy Jones, and Teresa Stanfill (St Luke’s Regional Medical Center, Boise, ID), Chris Jabaay, Carol Lawrence, Nancy Travis, Kim Vincent (Lee Memorial Health System, Fort Myers, FL), Gaylene Kramchynski, Susan Mussell, and Kris Robinson (St Boniface General Hospital, Winnipeg, MB), Annette McHugh, Glenys Roberts, Louise Taylor, and Grace Thomas (Royal Gwent Hospital, Gwent Healthcare NHS Trust, Newport, Wales), Pat Bielecki, Laurie Lang, Tammi Lothson, Debbie Lunardini, and Robyn Magnuson (Advocate Health Care—Lutheran General Hospital, Park Ridge, IL), Hazel Canavan, Tina Davis-Larkin, Elaine Perkins, Sue Riegel, and Lorian Williams (Advocate Health Care—Christ Hospital, Oak Lawn, IL), Carole England, Jayne Gregory, Debbie Patrick, and Hora Soltani (Derby City General, Derby, UK), Linda Koehl, Marcia Patterson, and Cheryl Stone (Rush University Medical Center, Chicago, IL), Patti Janssen, Monica Nicol, Lynne Palmer, and Lesley Smith (Surrey Memorial Hospital, Surrey, BC), and Carol Burke, Joy Grohar, Abby Hornbogen, and Donna Pemberton (Northwestern Memorial Hospital, Chicago, IL).
Contributors: All authors participated in writing the original grant application, were members of the steering committee to manage the trial, and contributed to all drafts of the manuscript. EH was the principal investigator and led the trial team. She contributed to analysing and interpreting the data, wrote the first draft, and is guarantor. AW was the trial statistician and contributed to the data analysis plan and supervision and is guarantor for the analyses. JW was the trial coordinator. During the time of the trial NKL was with the School of Nursing, Oregon Health and Science University, Portland, OR, USA.
Funding: Canadian Institutes of Health Research (grant No MCT59614).
Competing interests: None declared.
Ethical approval: Research ethics committees at the University of Toronto and by all participating hospitals.
Provenance and peer review: Not commissioned; externally peer reviewed.
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