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PAPERS:
Elizabeth R Cluett, Ruth M Pickering, Kathryn Getliffe, and Nigel James St George Saunders
Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour
BMJ 2004; 0: 379636064 [Abstract]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] Taking the waters - very early in life
Dr.Herbert H. Nehrlich   (6 February 2004)
[Read Rapid Response] Labour in water rather than birth
James B Robins   (6 February 2004)
[Read Rapid Response] "This Week in the BMJ" Labouring over editorial license
Robert Schumacher   (6 February 2004)
[Read Rapid Response] Labour in water - not birth in water
David J R Hutchon   (6 February 2004)
[Read Rapid Response] An editor confesses--and apologises to anybody upset
Richard Smith   (7 February 2004)
[Read Rapid Response] Swim baby swim
Dr.Herbert H. Nehrlich   (7 February 2004)
[Read Rapid Response] Headlines are both incorrect and misleading
Timothy Lloyd Watts   (9 February 2004)
[Read Rapid Response] Are the conclusions really supported by the data?
John D Blakey   (10 February 2004)
[Read Rapid Response] Misleading headlines muddy the water
Ruth Gilbert, Pat Tookey, Senior Lecturer in Epidemiology, Institute of Child Health   (11 February 2004)
[Read Rapid Response] Methodology is unclear
Jamal Zaidi, Fawzia Zaidi, Senior Lecturer University of Brighton   (12 February 2004)
[Read Rapid Response] Low tech interventions like this need more attention
Helen D Bradshaw   (12 February 2004)
[Read Rapid Response] misleading photograph and headlines
helene a. brandon   (17 February 2004)
[Read Rapid Response] What this study adds
Kate Farrer   (18 February 2004)
[Read Rapid Response] Is it worth the effort?
Hector J. Lacassie, Terrance W. Breen   (20 February 2004)
[Read Rapid Response] High risk of bias, incompatible comparison between randomised groups, inappropriate comment about neonatal morbidity and misleading headlines in cover page
Prithwiraj Saha, Meekai S To, Specialist Registrar; Rami K Atalla, Consultant Queen Elizabeth II Hospital, Welwyn Garden City, AL7 4HQ   (23 February 2004)
[Read Rapid Response] Misleading Advertising
Bernadette M White   (24 February 2004)

Taking the waters - very early in life 6 February 2004
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Dr.Herbert H. Nehrlich,
Private Practice
Bribie Island, Australia 4507

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Re: Taking the waters - very early in life

I find it a bit disturbing that, nowadays, no one seems to give credit where credit is due. While it is often difficult to determine the original source of some action I would think that it could be regarded as prudent to mention the thinker behind an idea. My wife was brave enough to try the "new" method of Dr. Leboyer in 1976 when our daughter was born on the 4th of July, 1976. Letter from the president, local mention as pioneer in the waterbirth method and she did turn out to be a real pleasure to have around. Dr. Leboyer was, of course, French and he was fascinated avec de l'eau (he did not use vin rouge in this application) and I, as a nervous observer, found the entire procedure rather pleasant. Then the strong arm of the State intervened and the rest of our kids were delivered in a rather dry environment. It seems that some of these more natural methods may have something.

Competing interests: None declared

Labour in water rather than birth 6 February 2004
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James B Robins,
Consultant
Inverclyde Royal Hospital, Greenock

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Re: Labour in water rather than birth

Fascinated by the article which reinforces anecdotal expereience. It has been long recognized that allowing a labouring patient to have a good soak in a deep bath will relieve pain and facilitate labour. A shame that the traditional big bath has been removed from the labour ward.

However, readers will have been misled by your cover page - "Giving Birth in Water". The study is about labouring in water not delivery. I don't know how many of these women chose to deliver in the water bath but from my quick scan through the paper I do not think that this was the intention. In fact I note that "there was a mean delay of 6 hours (range 2 -10 hours) between women leaving the pool and birth".

This study is on water immersion as an option from women in the first stage of labour not about delivery in water.

Competing interests: None declared

"This Week in the BMJ" Labouring over editorial license 6 February 2004
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Robert Schumacher,
Associate Professor of Pediatrics
University of Michigan Health Systems Ann Arbor Mi 48109-0254

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Re: "This Week in the BMJ" Labouring over editorial license

Cluett and investigator’s fine paper has successfully navigated it’s way across the North Atlantic labour pool.

As a neonatal physician I found the investigator’s conclusions regarding the newborns’ outcomes straightforward and reasonable. Four of the six infants were admitted to NICU with signs that could be related to the water birth (hypothermia (2), fever (1), suspected infection). Cluett concludes “It is clearly important to ensure ongoing audit of neonatal outcomes for women who labour in water.” Given this statement one wonders how Cluett et al feel about the editorial license taken by the BMJ in This week in the BMJ, specifically the statement “neonates in the water group were admitted to a neonatal unit for reasons apparently unrelated to water labouring.”

Competing interests: None declared

Labour in water - not birth in water 6 February 2004
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David J R Hutchon,
Consultant Obstetrician
Memorial Hospital, Darlington. DL3 6HX

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Re: Labour in water - not birth in water

The front page picture shows a somewhat misleading picture of a newborn baby and mother in the water suggesting that she had given birth in water. Indeed "birth in water" is the title of the picture. In fact the study in the journal to which the picture brings attention is a "..trial of labouring in water.." and there is no reference to birth in water. I very much support the concept of labour in water if it leads to less need for analgesia and epidural analgesia.

Competing interests: None declared

An editor confesses--and apologises to anybody upset 7 February 2004
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Richard Smith,
Editor
BMJ

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Re: An editor confesses--and apologises to anybody upset

I wrote the words on the cover of this week's BMJ. Initially I wrote: "Labouring in water." Unfortunately it made only one line, and we need two. I thus had to change it, and my first thought was "Giving birth in water." But,I wondered, did these women give birth in water? I quickly scanned the paper, and I didn't find the answer. Then I wondered if there was that much difference linguistically between "labouring" and "giving birth." Do people thinking of "giving birth" as the moment of birth or the longer process?

Then something else happened--as it always does--and I left it as "Giving birth in water."

I apologise to anybody who thinks it horribly wrong, but this little story illustrates the exigencies of putting a journal together.

Richard Smith, editor, BMJ

Competing interests: I'm the editor of the BMJ and accountable for all it contains.

Swim baby swim 7 February 2004
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Dr.Herbert H. Nehrlich,
Private Practice
Bribie Island, Australia 4507

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Re: Swim baby swim

I get the distinct impression that labor in water is deemed okay but anything beyond that borders on manslaughter. Yes, you can allow labor to proceed with the patient immersed in water and - lo and behold - the newborn baby is smart enough to actually "swim" into this new world of ours. From my own observation it is clear that the mother's comfort was no greater than the baby's. The expression on the baby's face was not one of distress but rather one of "let's get this over with, small task that it is". Perhaps one of our well-meaning (but rather stuffy) correspondents could watch a water birth? When my daughter was born (1976) Dr.Leboyer was the "in" doctor at the time, and the seeds of anti-establishment were in the air. The birth clinic we attended was, as the Americans say, quite "rinkidink" but the midwives and medical director were absolutely in charge. And, while my daughter undoubtedly remembers little if anything about her arrival she has expressed a strong interest in Dr.Leboyer's method for her children.

Competing interests: None declared

Headlines are both incorrect and misleading 9 February 2004
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Timothy Lloyd Watts,
Consultant Neonatologist
St Thomas' Hospital, SE1 7EH

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Re: Headlines are both incorrect and misleading

The paper by Cluett and Getliffe had some interesting findings regarding reduced epidural and augmentation rate in women who labour in the first stage in water. However, it quite rightly makes no claims about water birth.

The paper does not mention giving birth (as the BMJ cover states) or delivery in water (as the headline on the website states). Indeed, the length of delay between leaving the water and birth is quoted in the article - 6 hours (range 2-10 hours).

The other statement on the BMJ cover regarding the 'need for obstetric intervention' is also misleading as the immediate impression from this is that the use of water in labour or for delivery alters how the babies are delivered which is clearly not the case, with rates of normal birth, ventouse, forceps and caesarian section all being no different between both patient groups.

From the headlines in this issue of BMJ, readers might reasonably be expected to conclude that water birth improved the chances of normal delivery with no adverse outcomes for the baby. However, an accurate analysis of the paper itself can only conclude that spending some or all of the first stage of labour in water may reduce epidural or augmentation rates, but this may be at the expense of a higher risk of admission to neonatal units for intensive or special care.

The BMJ needs to take more care with how it reports papers within it. It does its readership or the authors of papers printed within it no favours by this lack of accuracy.

Competing interests: None declared

Are the conclusions really supported by the data? 10 February 2004
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John D Blakey,
research fellow
Division of Therapeutics, University of Nottingham

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Re: Are the conclusions really supported by the data?

I'll confess I know little about obstetrics, but happened to read this article. Two points concern me:

Firstly, labour in water did not reduce the need for obstetric intervention as stated in the abstract (note p>0.05). To speculate this trend would have become significant with larger numbers is equivalent to speculating the excess in neonatal unit outcomes would also become more significant.

Secondly the authors state that significantly fewer women randomised to water immersion received augmentation. This is an equivalent statement to saying more women in the arm randomised to augmentation received augmentation.

As the authors state, larger trials seem needed here.

Competing interests: None declared

Misleading headlines muddy the water 11 February 2004
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Ruth Gilbert,
Reader in Clinical Epidemiology
Institute of Child Health, 30 Guilford Street, London, WC1N 1EH,
Pat Tookey, Senior Lecturer in Epidemiology, Institute of Child Health

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Re: Misleading headlines muddy the water

The headline ‘Giving birth in water’ referring to the randomised controlled trial by Cluett et al(1) of water immersion versus augmentation for dystocia in labour, fuels the confusion about labour and delivery in water. This and other studies provide good evidence for the benefits of immersion in water during labour(2). But contrary to the BMJ headline, this study is not about the risks or benefits of delivery in water. Cluett et al reported a mean delay of 6 hours (range 2-10) between women leaving the pool and birth. We conducted a national surveillance study of deliveries in water and the results were compatible with there being a small overall increase or decrease in perinatal mortality among babies delivered in water(3). We concluded that perinatal mortality was not substantially higher among these infants than among those delivered conventionally. However, we, like others (4) did raise the possibility of specific harms, particularly for water aspiration and blood loss due to snapped umbilical cord. How should clinicians advise women wishing to deliver in water? The trial that needs to be done is to randomise women who labour in water, to pulling the plug (or getting out of the bath), versus remaining immersed for the second stage of labour. This may be difficult since women are likely to have strong preferences one way or the other!

Ruth Gilbert
Reader in Clinical Epidemiology

Pat Tookey ,br>Senior Lecturer in Epidemiology
Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health, London, WC1N 1EH

Correspondence to r.gilbert@ich.ucl.ac.uk

Reference List

1. Cluett ER, Pickering RM, Getliffe K, Saunders NJ. Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour. BMJ 2004;328:314.

2. Nikodem VC. Immersion in water during pregnancy, labour and birth (Cochrane Review). In: The Cochrane Library, Issue 3, 1998., Oxford: Update Software., 1998.

3. Gilbert RE,.Tookey PA. Perinatal mortality and morbidity among babies delivered in water: surveillance study and postal survey. BMJ 1999;319:483-7.

4. Nguyen S, Kuschel C, Teele R, Spooner C. Water birth--a near- drowning experience. Pediatrics 2002;110:411-3.

Competing interests: None declared

Methodology is unclear 12 February 2004
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Jamal Zaidi,
Consultant Obstetrician and Gynaecologist
Conquest Hospital, East Sussex,
Fawzia Zaidi, Senior Lecturer University of Brighton

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Re: Methodology is unclear

The methodology of this study requires clarification:

The authors have not defined the criteria by which the first stage of labour was diagnosed, thus putting into question the diagnosis of dystocia. In current practice an expectant policy is advocated especially during the latent phase of labour to avoid unnecessary intervention. It is unclear whether the authors have taken this into account and whether some women were inappropriately recruited. We suggest that an alternative arm of the study should have included an expectant group without recourse to water immersion or augmentation and thus the true impact of water immersion would be defined.

The inclusion of women with both intact and ruptured membranes in each study arm further adds to difficulty in evaluating the true effect of water immersion.

Competing interests: None declared

Low tech interventions like this need more attention 12 February 2004
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Helen D Bradshaw,
SpR Obstetrics and Gynaecology
Rotherham General Hospital, Rotherham S60 2UD

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Re: Low tech interventions like this need more attention

EDITOR- Cluett et al 1tackle an important area with their study comparing labouring in water with standard augmentation for dystocia in nulliparous women. Obstetricians and mid wives need to be able to provide credible evidence based answers to women’s queries about ‘low tech’ interventions such as this. Too often modern obstetrics concentrates on major medical interventions and neglects the simpler solutions that many women would prefer 2.

The study was obviously carefully considered and robustly designed. Unfortunately the conclusion used as a headline on the front cover is not supported by their findings. Labour in water may reduce medical intervention but several conflicting conclusions could also be drawn. Neither of their primary outcomes (epidural rates and operative delivery rates) were significantly different between the 2 groups, only by combining all outcome measures together was there a significant difference in medical intervention overall. An alternative conclusion could have been that labour in the pool is associated with significantly more neonatal morbidity, with 6 babies from this group admitted to special care and none from the standard augmentation group (p=0.013). Why didn’t this conclusion make it to the front cover?

The authors blame the absence of a statistically significant result on inadequate numbers and discuss the various reasons why recruitment to RCTs of obstetric interventions is often difficult. As they point out many women have preconceived ideas about how they would like labour to be managed and are not willing to be randomised. It is therefore particularly unfortunate that the authors’ attempts to address this important question do not seem to have been supported by the policy makers in their unit. The change in practice that occurred half way through their study adopting a more conservative approach to augmentation appears to have been based on pre existing research 3 rather than any contemporaneously published report. Surely it would have been ethical to delay such a policy change until the researchers had completed recruitment?

Helen Bradshaw
SpR Obstetrics and Gynaecology
Rotherham General Hospital, Rotherham, S. Yorkshire
h.d.bradshaw@sheffield.ac.uk

1. Cluett ER, Pickering RM, Getliffe K, Saunders NJ. Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour. Bmj 2004;328(7435):314.

2. Johanson R. Perineal massage for prevention of perineal trauma in childbirth. Lancet 2000;355(9200):250-1.

3. World Health Organisation. World Health Organization partograph in management of labour. World Health Organization Maternal Health and Safe Motherhood Programme. Lancet 1994;343(8910):1399-404.

Competing interests: None declared

misleading photograph and headlines 17 February 2004
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helene a. brandon,
consultant, obs and gynae
Queen Elizabeth Hospital, Gateshead, NE9 6SX

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Re: misleading photograph and headlines

The photograph and headlines used on your cover and inside this issue were unfortunate, as the paper by Cluett and colleagues was NOT about 'giving birth in water' or 'water delivery' at all - it was about LABOURING in water, and the delay between women leaving the pool and birth was 6 hours, range 2-10, ie none of them delivered in the water. Labouring in water may reduce the need for augmentation and other obstetric intervention, but women do not need to deliver in the pool to acheive this.

Competing interests: None declared

What this study adds 18 February 2004
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Kate Farrer,
Consultant Neonatologist
St. George's Hospital, London SW17 0QT

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Re: What this study adds

Dear Editor

The paper by Cluett et al (1) comparing augmented labour with water labour is flawed and I am amazed that it was published by the BMJ – a journal which usually laudably flies the flag for high quality, peer reviewed, medical journalism. Not only are the conclusions on the front cover and in the editorial not supported by the study but also those in the “what the study adds” sections are inaccurate. The front cover refers to water birth; the study examines water labour. The front cover says that the operative deliveries are increased. The study shows equal numbers of normal deliveries and operative deliveries. The study claims to demonstrate that women who labour in water have decreased need for augmentation, reduced pain and increased satisfaction. The design of the study requires women in one arm to be augmented; it is thus hardly surprising that there was less augmentation in the other group. The study only reports women’s experience of pain in the 30 minutes after the intervention started; assessment of pain throughout the whole delivery would have been a more useful outcome. Table 3 clearly shows that overall satisfaction was equivalent in both groups. It is inaccurate therefore to conclude increased satisfaction with water labour as a major outcome.

Further clarification about the methodology would have been useful. The editor comments “neonates in the water group were admitted to neonatal units for reasons apparently unrelated to water labouring.” Although numbers in this study are small a neonatal admission rate of 12% of low risk term new-borns is exceedingly alarming and warrants closer inspection and larger studies. 2 babies had hypothermia, one had fever and one had suspected sepsis. All of these conditions could relate to water labour and birth.

What this paper shows is that delaying augmentation “in a supportive environment” appears acceptable, safe for the mother and reduces the need for epidural. It is inaccurate for the authors and editor to reach other conclusions.

Yours faithfully

Dr K.F.M. Farrer Consultant Neonatologist

(1). Cluett et al. Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour. BMJ 2004;328:314

Competing interests: None declared

Is it worth the effort? 20 February 2004
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Hector J. Lacassie,
Anesthesiology Department
Duke University Medical Center, Box 3094, 27710, USA,
Terrance W. Breen

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Re: Is it worth the effort?

We read with great interest the article by Cluett et al.(1), examining the practice of labouring in water as treatment for dystocia. This is essentially a study of active management of labor (amniotomy +/- oxytocin) versus a conservative one, with the twist that the latter included 4 or more hours in a tub. We believe that the key elements to this kind of study are demonstration first of safety and second of efficacy.

We think that the authors should have emphasized neonatal and maternal adverse outcomes. The major finding in their study was a higher rate of neonatal intensive care admissions in the women assigned to the water group. While they try to reassure readers that others have not found this outcome, it was the most important finding in this study and raised concern about laboring in a tub.

Secondly, the authors did not prospectively assess maternal pain in labor. It is difficult, if not impossible, to draw a conclusion on this matter with such a design. In fact, the retrospective evaluation of pain may have flawed their results since 60% of women have imperfect recall of significant childbirth events(2). We predict that with greater epidural analgesia use in the active management group, labor pain control would have been better in that group (a finding the authors might not have wanted to know).

On the efficacy arm of the study, the authors make statements that are not supported by their own statistics. The 95% confidence interval for use of epidural analgesia was 0.49 to 1.01. Therefore, there was NO difference in epidural use. The number needed to treat (NNT) reported in the abstract was not correct for a non statistically significant difference(3) and makes it pejorative as quoted. The authors suggest that for laboring in water was positive with an NNT for benefit (no epidural) of 5. It is purely a value judgment whether or not “sparing” one woman in five from receiving epidural analgesia is a benefit. This information belongs in the discussion of the paper as trend data and has no place in the abstract results (other than perhaps that there was NO difference in the utilization of epidural analgesia).

Finally, we are concerned about the way the findings are highlighted in the journal. Many casual readers check the BMJ website and “This week in the BMJ”, skim abstracts or look at the “What is already known about this topic” and “What this study adds” section”. The BMJ website and the cover of this issue draws attention to this study with the picture of a woman and newborn in a tub, implying the safety and efficacy of this practice. We have already criticized the abstract for inaccurate information. We believe the main finding of this study was the unexpected rate of neonatal admission to the intensive care nursery and no difference in epidural usage rate. Therefore, we believe the “What this study adds” section should be that the study casts doubt on the safety of labouring in water and that further safety and efficacy data are required before labouring in a tub can be recommended.

With these arguments in mind, the question remains: Is it worth the effort to induce patients to have their labors in the water if it increases the risk of newborns to end up in a neonatal unit, with marginal benefits in obstetrical management? We think that it is not.

References:

1. Cluett ER, Pickering RM, Getliffe K, Saunders NJ. Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour. Bmj 2004;328:314. 2. Elkadry E, Kenton K, White P et al. Do mothers remember key events during labor? Am J Obstet Gynecol 2003;189:195-200. 3. Altman DG. Confidence intervals for the number needed to treat. Bmj 1998;317:1309-12.

Competing interests: None declared

High risk of bias, incompatible comparison between randomised groups, inappropriate comment about neonatal morbidity and misleading headlines in cover page 23 February 2004
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Prithwiraj Saha,
Specialist Registrar
Chase Farm Hospital, Enfield, EN2 8JL,
Meekai S To, Specialist Registrar; Rami K Atalla, Consultant Queen Elizabeth II Hospital, Welwyn Garden City, AL7 4HQ

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Re: High risk of bias, incompatible comparison between randomised groups, inappropriate comment about neonatal morbidity and misleading headlines in cover page

Editor - We read Elizabeth R Cluett et al study1 with great interest. Being fully aware of the limitation of the study due to small number of women recruited, there was an alarming risk of bias. Although they stated that there were no important differences in baseline characteristics, the reader was not able to judge this, as details of patients' demographics were not provided. Surely we need to know exactly which characteristics the authors considered important. The authors did not specify whether there were a consistent time interval between the delivery and the postpartum interviews, as women recollection of labour experience and pain could considerably change with time delays. Also, whether interviewers were blinded to the randomisation or were the same carers managing the labour which could create a potential bias.

In the augmentation group labour was augmented 2 hours after randomisation while after 4 hours in the labour in water group. The delay in augmentation is known to be associated with a decrease in operative intervention with minimal impact on the duration of labour2,3 and was adopted in the author's unit1. Therefore, the comparison between the two groups was not compatible.

Furthermore, women in the augmentation group were allocated to have their labour augmented as per randomisation, therefore augmentation could not be considered an outcome parameter and not surprisingly the authors found that there is a statistical significant difference when augmentation was considered as an obstetric intervention.

There were 6 neonates born to women in labour in water group who required admission to neonatal unit comparing to none in the augmentation group, a significant morbidity (p=0.013) and only one of them had cardiac defect (i.e. unrelated to the intervention). It was surprising that the authors concluded that the trial was not large enough to detect differences in foetal morbidity. As the causes of admission were hypothermia, fever, suspected infection and poor feeding, it is difficult to share the authors' view.

Finally, the title on the cover of the BMJ"Giving birth in water, may reduce obstetric intervention" is misleading as the women allocated to the labour in water group only laboured in water for 4 hours in the first stage and might not have given birth in water neither there was any reduction in operative delivery.

1 Elizabeth R Cluett, Ruth M Pickering, Kathryn Getliffe, Nigel James St George Saunders. Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour. BMJ 2004;328:314-8(7th February)

2 Frigoletto FD, Lieberan E, Lang JM et al. A clinical trial of active management of labour. NEJM 1995;333:450-4

3 World Health Organisation maternal health and safe motherhod programme. World Health Organisation partograph in the management of labour. Lancet 1994;343:1399-404

Competing interests: None declared

Misleading Advertising 24 February 2004
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Bernadette M White,
Clinical Director, Obstetrics
Mercy Hospital for Women, Melbourne, Vic , Australia

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Re: Misleading Advertising

Editor

The front page of BMJ,7 February 2004 proclaimed "Giving birth in water - may reduce the need for obstetric intervention". The article was not about giving birth in water (a peculiar but controversial practice ) but about immersion in water during labour. All subjects delivered on dry land.There is enough nonsense talked on this topic as it is without confusing the issue.

Bernadette White

Competing interests: None declared