Comparing Different Partograph Designs for Use in Standard Labor Care: A Pilot Randomized Trial
Tóm tắt
Backgound Partographs are used in many labour settings to provide a pictorial overview of a woman’s cervical dilation pattern in the first stage of labor and to alert clinicians to slow progress possibly requiring intervention. Recent reviews called for large trials to establish the efficacy of partographs to improve birth outcomes whilst highlighting issues of clinician compliance with use. Previous studies have also reported issues with participant recruitment related to concerns regarding the possibility of a longer labour. Objectives We sought to compare a standard partograph with an action line, to a newly designed partograph with a stepped line, to determine the feasibility of recruitment to a larger clinical trial. Methods A pragmatic, single-blind randomised trial wherein low-risk, nulliparous women in spontaneous labour at term were randomized to an action-line or stepped-line partograph. First stage labour management was guided by the allocated partograph. Primary outcomes included the proportion of eligible women recruited, reasons for failed recruitment and compliance with partograph use. Secondary outcomes included rates of intervention, mode of birth, maternal and neonatal outcomes. Results Of the 384 potentially eligible participants, 38% (149/384) were approached. Of these 77% (116/149) consented, with 85% (99/116) randomized, only nine women approached (6%) declined to participate. A further 9% (14/149) who were consented antenatally were not eligible at onset of labor and 7% (10/149) of women approached in the birth suite but did not meet the inclusion criteria. Compliance with partograph completion was 65% (action) versus 84% (dystocia line). Conclusions for Practice Participant recruitment to a larger randomized controlled trial comparing new labour management guidelines to standard care is feasible. Effective strategies to improve partograph completion compliance would be required to maintain trial fidelity.
Tài liệu tham khảo
American College of Obstetricians and Gynecologists. (2014). Obstetric care consensus no. 1: Safe prevention of the primary cesarean delivery. Obstetrics & Gynecology, 123(3), 693–711.
Bluestone, J., Fullerton, J., Carr, C., Alderman, J., & BonTempo, J. (2013). Effective in-service training design and delivery: Evidence from an integrative literature review. Human Resource Health, 11(1), 51.
Cohen, W. R. & Friedman, E. A. (2015a). Misguided guidelines for managing labor. American Journal of Obstetrics and Gynecology, 212(6), 753.e751–753.e753. doi:10.1016/j.ajog.2015.04.012.
Cohen, W. R. & Friedman, E. A. (2015b). Perils of the new labor management guidelines. American Journal of Obstetrics and Gynecology, 212(4), 420–427. doi:10.1016/j.ajog.2014.09.008.
de Azevedo Aguiar, C., & Tanaka, A. C. D. A. (2013). Use of the partogram in labor: Analysis of its application in different care models. Open Journal of Obstetrics and Gynecology, 3(09), 1.
Fletcher, B., Gheorghe, A., Moore, D., Wilson, S., & Damery, S. (2012). Improving the recruitment activity of clinicians in randomised controlled trials: A systematic review. BMJ Open. doi:10.1136/bmjopen-2011-000496.
Friedman, E. A. (1955). Primigravid labor: A graphicostatistical analysis. Obstetrics & Gynecology, 6, 567–589.
Martin, C. J. H., & Martin, C. R. (2014). Development and psychometric properties of the Birth Satisfaction Scale-Revised (BSS-R). Midwifery, 30(6), 610–619.
Kitila, S. B., Gmariam, A., Molla, A., & Nemera, G. (2014). Utilization of partograph during labour and birth outcomes at Jimma University. Journal of Pregnancy and Child Health, 1(101), 2.
Kline, P. (2000). A psychometrics primer. London: Free Assn Books.
Laughon, S. K., Branch, D. W., Beaver, J., & Zhang, J. (2012). Changes in labor patterns over 50 years. American Journal of Obstetrics and Gynecology, 206(5), 419.e411–419.e419. doi:10.1016/j.ajog.2012.03.003.
Lavender, T., Alfirevic, Z., & Walkinshaw, S. (2006). Effect of different partogram action lines on birth outcomes: A randomized controlled trial. Obstetrics & Gynecology, 108(2), 295–302.
Lavender, T., Hart, A., & Smyth, R. M. (2013). Effect of partogram use on outcomes for women in spontaneous labour at term. London: The Cochrane Library.
Neal, J. L., & Lowe, N. K. (2012). Physiologic partograph to improve birth safety and outcomes among low-risk, nulliparous women with spontaneous labor onset. Medical Hypotheses, 78(2), 319–326.
Neal, J. L., Lowe, N. K., Ahijevych, K. L., Patrick, T. E., Cabbage, L. A., & Corwin, E. J. (2010). “Active labor” duration and dilation rates among low-risk, nulliparous women with spontaneous labor onset: A systematic review. Journal of Midwifery & Women’s Health, 55(4), 308–318.
Neal, J. L., Ryan, S. L., Lowe, N. K., Schorn, M. N., Buxton, M., Holley, S. L. & Wilson-Liverman, A. M. (2015). Labor dystocia: Uses of related nomenclature. Journal of Midwifery & Women’s Health, 60(5), 485–498.
O’Driscoll, K., Stronge, J. M., & Minogue, M. (1973). Active management of labour. BMJ (Clinical Research Ed.), 3(5872), 135–137.
Opiah, M. M., Ofi, A. B., Essien, E. J., & Monjok, E. (2012). Knowledge and utilization of the partograph among midwives in the Niger Delta region of Nigeria: Original research article. African Journal of Reproductive Health, 16(1), 125–132.
Patsopoulos, N. A. (2011). A pragmatic view on pragmatic trials. Dialogues in Clinical Neuroscience, 13(2), 217–224.
Peisner, D., & Rosen, M. (1986). Transition from latent to active labor. Obstetrics & Gynecology, 68(4), 448–451.
Philpott, R. H. & Castle, W. M. (1972a). Cervicographs in the management of labour in primigravidae. I. The alert line for detecting abnormal labour. The Journal of Obstetrics and Gynaecology of the British Commonwealth, 79(7), 592.
Philpott, R. H. & Castle, W. M. (1972b). Cervicographs in the management of labour in primigravidae. II. The action line and treatment of abnormal labour. J Obstet Gynaecol Br Commonw, 79(7), 599.
Rouquette, A. & Falissard, B. (2011). Sample size requirements for the internal validation of psychiatric scales. International Journal of Methods in Psychiatric Research, 20(4), 235–249.
Sussman, J. B. & Hayward, R. A. (2010). An IV for the RCT: Using instrumental variables to adjust for treatment contamination in randomised controlled trials. BMJ (Clinical Research Ed.), 340, c2073.
Takehara, K., Noguchi, M., Shimane, T., & Misago, C. (2014). A longitudinal study of women’s memories of their childbirth experiences at five years postpartum. BMC Pregnancy and Childbirth, 14(1), 221. doi:10.1186/1471-2393-14-221.
Torgerson, D. J. (2001). Contamination in trials: Is cluster randomisation the answer? BMJ: British Medical Journal, 322(7282), 355–357.
Windrim, R., Seaward, P. G., Hodnett, E., Akoury, H., Kingdom, J., & Salenieks, M. E. (2007). A randomized controlled trial of a bedside partogram in the active management of primiparous labour. Ryan, JOGC-Toronto, 29(1), 27.
World Health Organization. (1994). The partograph: The application of the WHO partograph in the management of labour. Report of a WHO multicentre study (pp. 1990–1991). Geneva: WHO.
Zhang, J., Landy, H. J., Branch, D. W., Burkman, R., Haberman, S., & Gregory, K. D., … Gonzalez-Quintero, V. H. (2010). Contemporary patterns of spontaneous labor with normal neonatal outcomes. Obstetrics and Gynecology, 116(6), 1281.