Is a randomized controlled trial of waterbirth possible? An Australian feasibility study

Jyai Allen, Yu Gao, Hannah Dahlen, Maree Reynolds, Michael Beckmann, Catherine Cooper, Sue Kildea

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)
37 Downloads (Pure)

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.

Original languageEnglish
Pages (from-to)697-708
Number of pages12
JournalBirth
Volume49
Issue number4
Early online date4 Apr 2022
DOIs
Publication statusPublished - Dec 2022

Bibliographical note

Funding Information:
We would like to acknowledge Jo Hoey, Lucinda Whybrow, Bekki Cavallaro, and Loris Muir for recruitment and data collection; Melissa Fox and Dr Nigel Lee for study conceptualization; and Dr David Tudehope, Professor Jenny Fenwick, and Professor David Ellwood for data safety and monitoring committee. Open access publishing facilitated by Griffith University, as part of the Wiley - Griffith University agreement via the Council of Australian University Librarians. [correction added on May 13, 2022, after first online publication: CAUL funding statement was added.]

Publisher Copyright:
© 2022 The Authors. Birth published by Wiley Periodicals LLC.

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