TY - JOUR
T1 - A pilot study for a randomised controlled trial of water birth versus land birth
AU - Woodward, J
AU - Kelly, Susan
PY - 2004/6/1
Y1 - 2004/6/1
N2 - Objectives To assess the feasibility of undertaking an adequately powered multicentre study comparing waterbirth with land birth. To assess whether women are willing to participate in such a trial and whether participation has a negative effect on their birthing experience.
Design A randomised controlled trial (RCT) with 'preference arm'.
Setting District general hospital with 3600 deliveries annually.
Population Women with no pregnancy complications and no anticipated problems for labour/delivery.
Methods Women were recruited and randomised between 36 and 40 weeks of gestation. Comparison of randomised and 'preference arm' to assess any impact of randomisation on women's birthing experience.
Main outcome measures Data were collected at delivery concerning the labour, the pool water and baby's condition at birth and six weeks of age. The main outcome measures are means and standard deviation of cord O-2, CO2, haemoglobin, haematocrit and base excess; medians and ranges of time to first breathe and cord pH; bacterial growth from pool water samples and neonatal swabs; and maternal satisfaction.
Results Eighty women participated-60 women were randomised. Twenty women participated in a nonrandomised 'preference arm'. The babies randomised to a waterbirth demonstrated a significantly lower umbilical artery pCO(2) (P = 0.003); however, it is recognised that this study is underpowered. Women were willing to participate and randomisation did not appear to alter satisfaction.
Conclusion This small study has shown that a RCT is feasible and demonstrated outcome measures, which can be successfully collected in an average delivery suite.
AB - Objectives To assess the feasibility of undertaking an adequately powered multicentre study comparing waterbirth with land birth. To assess whether women are willing to participate in such a trial and whether participation has a negative effect on their birthing experience.
Design A randomised controlled trial (RCT) with 'preference arm'.
Setting District general hospital with 3600 deliveries annually.
Population Women with no pregnancy complications and no anticipated problems for labour/delivery.
Methods Women were recruited and randomised between 36 and 40 weeks of gestation. Comparison of randomised and 'preference arm' to assess any impact of randomisation on women's birthing experience.
Main outcome measures Data were collected at delivery concerning the labour, the pool water and baby's condition at birth and six weeks of age. The main outcome measures are means and standard deviation of cord O-2, CO2, haemoglobin, haematocrit and base excess; medians and ranges of time to first breathe and cord pH; bacterial growth from pool water samples and neonatal swabs; and maternal satisfaction.
Results Eighty women participated-60 women were randomised. Twenty women participated in a nonrandomised 'preference arm'. The babies randomised to a waterbirth demonstrated a significantly lower umbilical artery pCO(2) (P = 0.003); however, it is recognised that this study is underpowered. Women were willing to participate and randomisation did not appear to alter satisfaction.
Conclusion This small study has shown that a RCT is feasible and demonstrated outcome measures, which can be successfully collected in an average delivery suite.
UR - http://www.scopus.com/inward/record.url?scp=2942574270&partnerID=8YFLogxK
U2 - 10.1111/j.1471-0528.2004.00132.x
DO - 10.1111/j.1471-0528.2004.00132.x
M3 - Article
C2 - 15198780
SN - 1471-0528
VL - 111
SP - 537
EP - 545
JO - BJOG
JF - BJOG
ER -