Is a randomized controlled trial of waterbirth possible? An Australian feasibility study
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Gao, Yu
Dahlen, Hannah
Reynolds, Maree
Beckmann, Michael
Cooper, Catherine
Kildea, Sue
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Abstract
Background: The safety of waterbirth is contested because of the lack of evidence from randomized trials and conflicting results. This research assessed the feasibility of a prospective study of waterbirth (trial or cohort). Methods: We conducted a prospective cohort study at an Australian maternity hospital. Eligible women with uncomplicated pregnancies at 36 weeks of gestation were recruited and surveyed about their willingness for randomization. The primary midwife assessed waterbirth eligibility and intention on admission in labor, and onset of second stage. Primary outcomes measured feasibility. Intention-to-treat analysis, and per-protocol analysis, compared clinical outcomes of women and their babies who intended waterbirth and nonwaterbirth at onset of second stage. Results: 1260 participants were recruited; 15% (n = 188) agreed to randomization in a future trial. 550 women were analyzed by intention-to-treat analysis: 351 (waterbirth) and 199 (nonwaterbirth). In per-protocol analysis, 14% (n = 48) were excluded. Women in the waterbirth group were less likely to have amniotomy and more likely to have water immersion and physiological third stage. There were no differences in other measures of maternal morbidity. There were no significant differences between groups for serious neonatal morbidity; four cord avulsions occurred in the waterbirth group with none in the landbirth group. An RCT would need approximately 6000 women to be approached at onset of second stage. Conclusions: A randomized trial of waterbirth compared with nonwaterbirth, powered to detect a difference in serious neonatal morbidity, is unlikely to be feasible. A powered prospective study with intention-to-treat analysis at onset of second stage is feasible.
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Birth: Issues in Perinatal Care
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49
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4
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© 2022 The Authors. Birth published by Wiley Periodicals LLC. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
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Subject
Models of care and place of birth
Midwifery
Patient safety
Science & Technology
Life Sciences & Biomedicine
Nursing
Obstetrics & Gynecology
Pediatrics
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Allen, J; Gao, Y; Dahlen, H; Reynolds, M; Beckmann, M; Cooper, C; Kildea, S, Is a randomized controlled trial of waterbirth possible? An Australian feasibility study, Birth: Issues in Perinatal Care, 2022, 49 (4), pp. 697-708