DOI: 10.1111/1471-0528.12139 www.bjog.

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BJOG Editors Choice

BJOG Editors Choice

In this issue, we have included two randomised trials that demonstrate non-signicant results. Both these studies evaluate interventions that are commonly discussed in clinical practice but their clinical utility has been poorly evaluated within gold standard study designs. In the past, there has been a perception that non-signicant results are not attractive to leading journals and perhaps not perceived as a priority for publication by authors, peer-reviewers and editors. There is now, however, a drive to prospectively register trials, and to make their protocols open for scrutiny. On the balance of probabilities it is likely that many adequately powered and optimally designed studies will demonstrate equivocal results. As discoverers curse, publication bias and play of chance all collude to give misleading information on interventions from the start, but these negative ndings are important in getting a handle on reality. In both of the trials highlighted below, the nature of their interventions makes it difcult to design pragmatic studies without potential aws. The authors of both trials suggest scope for further trials based on the ndings of their research. observers can be difcult to standardise: several studies have shown low levels of agreement of pain experienced by women compared with observers. Most studies assessing pain experience employ the use of analgesics as a surrogate measure of the pain experienced. In the RCT by Werner published in this issue on page 346, a 3-week course on selfhypnosis was given to women in the third trimester of pregnancy. This was compared with relaxation methods and standard antenatal care. Results show no signicant differences in the use of epidural analgesia between the two groups. The majority of previous studies that have demonstrated a benet from self-hypnosis have been observational; but the benet is less conclusive in published RCTs (Figure 1). However, many of the RCTs published have been underpowered, were published several years ago, may not represent current techniques of hypnosis, and only include low-risk antenatal care. Furthermore, the trials that started hypnosis early in pregnancy demonstrated greater effects compared with those that started hypnosis in the third trimester. A current ongoing RCT (http://isrctn.org/ISRCTN2757 5146) aims to evaluate the impact of earlier self-hypnosis training on labour pain with similar outcome measures to the RCT in this issue.
Study Year Sample size

Coitus to expedite the onset of labour

I have not practised any obstetric care for over a decade but I can still remember many women approaching 40 weeks of gestation requesting early elective induction of labour. Many midwives tongue in cheek response was that sex will stimulate labour! Like many old wives tales it is difcult to know whether they are based on fact or ction. Many observational studies have hypothesised that the high prostaglandin content of semen might act as an initiator of labour or it might be physical stimulation of the lower uterine segment. Only one RCT by Bavold in 1990 has been published comparing a group of women who were encouraged to have vaginal intercourse at term with a group who were told to abstain from sex. This trial was grossly underpowered and the trial methodology is not clear, but their ndings did not seem to show any difference in delivery rates. I was intrigued when I read the new RCT on page 338 by Omar et al. from Malaysia who randomised couples to two groups; one promoting regular sexual intercourse after 36 weeks of gestation and another group acted as a control with no advice about sex. This study had adequate randomisation and recruited 1200 women. Coital activity was statistically greater in the intervention arm. There was no difference in gestational age at delivery

Hypnosis for labour pain

Labour pain is inevitably the most common factor that can have a negative impact on the experience of childbirth. In this issue, we publish the results of a randomised controlled trial (RCT) comparing self-hypnosis with relaxation methods and traditional antenatal care. The experience of pain during labour varies considerably from a small number of women experiencing no pain to the majority experiencing severe pain. Severe labour pain can have signicant long-term sequelae with some women such as postnatal depression, traumatic stress disorder, requests for future caesarean section and occasionally a reluctance to have further pregnancies. It has been demonstrated that anxiety, fear, support from a birthing partner, coping skills and relaxation techniques can all inuence the experience of childbirth. Anxiety and fear have been associated with high levels of pain experienced in labour and women who have the continuous support of a partner are less likely to have analgesics. Objective measurement of labour pain is often difcult to replicate as assessment of the severity of pain experienced by women and the perception of pain by

Effect

Hypnosis Mehl-Madrona 2004 Martin 2001 Cyna 2011 Freeman 1986 Harmon 1990 Rock 1969 Werner 2013 520 42 305 59 60 40 723

0.70 [0.48, 1.00] Summary Relative Risk

Coitus to induce labour Bendvold 1990 Omar 2013 28 1150

Favours Intervention

0.99 [0.45, 2.20] Relative Risk 0.10 [0.24, 0.04] Mean Difference Favours Control

Figure 1. RCTs evaluating pharmacological analgesics used in labour in women who have received self-hypnosis training compared with control groups and evaluating coitus to induce labour.

2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2013 RCOG

BJOG Editors Choice

in the two arms of the study nor were there any differences in induction rates or premature rupture of membranes. So this relatively large RCT echoed the results of Bavold (Figure 1). From the limited evidence, vaginal coitus does not appear to inuence delivery outcomes, and its promotion can be dismissed from our antenatal clinics as an effective means of labour induction. What it does demonstrate is that there is no harm in having vaginal intercourse at term. Whether couples want to listen to evidence-based medicine or not is a different matter! The trial can be criticised as only 16% of women returned their coital diaries, so follow-up telephone interviews were made, which might allow scope for recall bias. Furthermore, sexual activity in the control arm was unexpectedly high, which might negate the effect of coitus in the control arm. So if there are any budding triallists out there who want to denitively answer this question, there is still scope for a future RCT.

Study year
Derman 2006 Mobeen 2010 Nasreen 2011 Sanghvi 2004

Sample size
1620 1072 1892 1488

Effect

0.64 [0.55, 0.74] Summary Relative Risk Favours Intervention Favours Control

Figure 2. Controlled studies comparing the risk of PPH after administration of misoprostol compared with control in home settings.

Should oral misoprostol be used to prevent PPH in home birth settings in low resource countries?
Postpartum haemorrhage (PPH) remains one of the leading causes of maternal death in sub-Saharan Africa and south-east Asia. In contrast to oxytocin, which tends to be given by birth attendants in birthing centres, misoprostol has attracted interest because it is inexpensive, does not require cold-chain storage, is administered orally, and can be administered by a non-skilled attendant. Community-based administration of misoprostol to women in developing countries in areas without skilled birth attendants will have a signicant impact on the prevention of PPH

with simulation models suggesting around a 40% reduction in incidence of signicant PPH. Hundley et al. on page 277 attempt to assess the evidence for misoprostol usage in low-resource countries. Two randomised and four non-randomised controlled studies were identied. Five studies in this review used a 600-lg dose of misoprostol; however, the most recent used a lower dose of 400 lg. In the majority of studies, a healthcare worker was trained to identify early warning signs of PPH and give the misoprostol accordingly. Four studies including the two RCTs used PPH >500 ml as an outcome measure and all four demonstrated a signicant reduction in signicant blood loss (Figure 2). Shivering and fever were the most common adverse effects. One concern is the inappropriate use of misoprostol as a stimulant of labour and administration before the birth of a second twin. It is therefore essential to have effective educational programmes for individuals and birth attendants. The overall conclusion is that oral misoprostol administered to women in low-resource countries signicantly reduces complications secondary to PPH. Its routine administration is likely to reduce the risk of maternal death in home settings.

BJOG themed issue on the scarred uterus

And nally, I am pleased to announce that the 2014 January themed edition of BJOG will concentrate on the management of pregnancy following caesarean section. In the UK, the National Institute of Clinical Excellence evidence-based guidance on management of pregnancy after caesarean section demonstrated many areas that are grey areas for best practice. In many developed countries, there has been a signicant increase in the number of caesarean sections combined with a change in womens expectations of childbirth. A themed edition concentrating on womens preferences and effective peripartum care will be eagerly awaited by all obstetricians and gynaecologists. The editorial team would welcome any RCTs, systematic reviews and novel primary research in this eld. Please go to www.BJOG.org for more information. &

Pierre Martin-Hirsch Deputy Editor-in-Chief

BJOG goes a step further in doing its bit for authors

BJOG Editors are constantly looking at ways to improve the visibility and dissemination of the original scientic research from our authors published in the journal. We already achieve this in a number of ways including Journal Club, podcasts, Twitter, Facebook, Google+, Linked In, videos, minicommentaries and press releases to name a few. Our latest offering is to collaborate with The Obstetrician and Gynaecologist (TOG), a CPD (continuing professional development) or CME (continuing medical education) jour-

nal circulated to approximately 11 500 members of the Royal College of Obstetricians and Gynaecologists, UK. From now on, we will select BJOG articles to have accompanying CPD questions published in TOG as part of the knowledge-based assessment requirement of the CPD programme. Authors of these selected articles will be invited to submit CPD creditable questions that can be answered using the information within their paper. Preparing questions is not an onerous task and guidelines will be available. Questions will be sent to TOG CPD editors for approval. The rst set of questions related to a BJOG paper appears in the January

2013 issue of TOG, which is free to view on Wiley Online Library (http://onlinetog.org). We envisage this exciting initiative to raise the prole, readership, citations and incorporation into practice of our papers. If you would like to have your papers considered for this initiative, please contact me at bjog@rcog.org.uk, giving reasons why you think your work will be suitable for CPD. &

Khalid Khan Editor-in-Chief

2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology 2013 RCOG