Kate F. Walker

The interobserver reliability of off‐line antral follicle counts made from stored three‐dimensional ultrasound data: a comparative study of different measurement techniques

To assess the interobserver reliability of antral follicle counts (AFCs) made from stored three‐dimensional (3D) ultrasound data using conventional two‐dimensional (2D) images, 3D multiplanar view and 3D‐rendered ‘inversion mode’.

Do surgical techniques used in groin lymphadenectomy for vulval cancer affect morbidity rates

Objective: To determine the complication rates associated with differing surgical techniques for groin node dissection for vulval cancer. Materials and Methods: We performed a retrospective case note review of patients undergoing groin node dissection for vulval cancer between 2001 and 2009 at Nottingham University Hospitals NHS Trust. Results: Notes for 56 patients undergoing a total of 98 groin node dissections were examined. Sixty-four percent of the patients had at least one complication from surgery. The use of suction drains was not associated with an increase in complications. However, when drains were used, a short duration of use was associated with high rates of wound breakdown and a long duration of use was associated with higher rates of lymphedema. The use of staples for skin closure was associated with an increased risk of lymphocysts and chronic lymphedema. The greater the number of nodes collected at lymphadenectomy, the higher the risk of lymphocysts and lymphedema. Conclusions: We recommend the use of subcuticular suture for wound closure. Patients who undergo lymphadenectomy with a node count per groin of more than 7 should be closely monitored for lymphedema and referred promptly to specialist services. The prolonged use of suction drainage may increase the risk of lymphedema.

Discrepancies between registration and publication of randomised controlled trials: an observational study

Summary Objectives To determine the consistency between information contained in the registration and publication of randomised controlled trials (RCTs). Design An observational study of RCTs published between May 2011 and May 2012 in the British Medical Journal (BMJ) and the Journal of the American Medical Association (JAMA) comparing registry data with publication data. Participants and Settings Data extracted from published RCTs in BMJ and JAMA. Main outcome measures Timing of trial registration in relation to completion of trial data collection and publication. Registered versus published primary and secondary outcomes, sample size. Results We identified 40 RCTs in BMJ and 36 in JAMA. All 36 JAMA trials and 39 (98%) BMJ trials were registered. All registered trials were registered prior to publication. Thirty-two (82%) BMJ trials recorded the date of data completion; of these, in two trials the date of trial registration postdated the registered date of data completion. There were discrepancies between primary outcomes declared in the trial registry information and in the published paper in 18 (47%) BMJ papers and seven (19%) JAMA papers. The original sample size stated in the trial registration was achieved in 24 (60%) BMJ papers and 21 (58%) JAMA papers. Conclusions Compulsory registration of RCTs is meaningless if the content of registry information is not complete or if discrepancies between registration and publication are not reported. This study demonstrates that discrepancies in primary and secondary outcomes and sample size between trial registration and publication remain commonplace, giving further strength to the World Health Organisation’s argument for mandatory completion of a minimum number of compulsory fields.

Induction of labour versus expectant management for nulliparous women over 35 years of age: a multi-centre prospective, randomised controlled trial

BackgroundBritish women are increasingly delaying childbirth. The proportion giving birth over the age of 35 rose from 12% in 1996 to 20% in 2006. Women over this age are at a higher risk of perinatal death, and antepartum stillbirth accounts for 61% of all such deaths. Women over 40 years old have a similar stillbirth risk at 39 weeks as women who are between 25 and 29 years old have at 41 weeks.Many obstetricians respond to this by suggesting labour induction at term to forestall some of the risk. In a national survey of obstetricians 37% already induce women aged 40–44 years. A substantial minority of parents support such a policy, but others do not on the grounds that it might increase the risk of Caesarean section. However trials of induction in other high-risk scenarios have not shown any increase in Caesarean sections, rather the reverse. If induction for women over 35 did not increase Caesareans, or even reduced them, it would plausibly improve perinatal outcome and be an acceptable intervention. We therefore plan to perform a trial to test the effect of such an induction policy on Caesarean section rates.This trial is funded by the NHS Research for Patient Benefit (RfPB) Programme.DesignThe 35/39 trial is a multi-centre, prospective, randomised controlled trial. It is being run in twenty UK centres and we aim to recruit 630 nulliparous women (315 per group) aged over 35 years of age, over two years. Women will be randomly allocated to one of two groups:Induction of labour between 390/7 and 396/7weeks gestation.Expectant management i.e. awaiting spontaneous onset of labour unless a situation develops necessitating either induction of labour or Caesarean Section.The primary purpose of this trial is to establish what effect a policy of induction of labour at 39 weeks for nulliparous women of advanced maternal age has on the rate of Caesarean section deliveries. The secondary aim is to act as a pilot study for a trial to answer the question, does induction of labour in this group of women improve perinatal outcomes? Randomisation will occur at 360/7 – 396/7 weeks gestation via a computerised randomisation programme at the Clinical Trials Unit, University of Nottingham. There will be no blinding to treatment allocation.DiscussionThe 35/39 trial is powered to detect an effect of induction of labour on the risk of caesarean section, it is underpowered to determine whether it improves perinatal outcome. The current study will also act as a pilot for a larger study to address this question.Trial registrationISRCTN11517275

Levonorgestrel intra-uterine system as a treatment option for complex endometrial hyperplasia

OBJECTIVE The objective of this study was to evaluate the potential treatment of atypical and non-atypical endometrial hyperplasia with the levonorgestrel intrauterine system (LNG-IUS). STUDY DESIGN A prospective observational study was undertaken at Queens Medical Centres menstrual disorder clinic between 2001 and 2008. Women presenting with abnormal perimenopausal and postmenopausal bleeding, underwent an endometrial biopsy followed by the insertion of a levonorgestrel intrauterine system (LNG-IUS). The study population comprised of 51 patients. The histology of 32 patients (Group A) showed complex hyperplasia without atypia, and in 19 patients (Group B), biopsy revealed atypical endometrial hyperplasia. These patients chose to be managed conservatively with repeat sampling of the endometrium. RESULTS Group A: 28 (87.5%) patients out of 32 had regression of their endometrial hyperplasia within the first 12 months of follow-up. Three of the patients achieved regression by 24 months increasing regression rate to 96.8% and the remaining one had a hysterectomy due to a rare side effect. Group B: 16 (84.2%) of 19 patients had regression of the atypical hyperplasia after treatment with the intrauterine system within 12 months of treatment. One patient achieved regression of the hyperplasia by 24 months and two patients went on to have surgical management due to persistent atypia and severe atypia respectively. CONCLUSION This study contribute further evidence that illustrates that levonorgestrel intrauterine systems have a potential role in patients requiring non-operative management although close follow-up is essential.

Induction of labour at term for women over 35 years old: a survey of the views of women and obstetricians

OBJECTIVES To determine the views of UK women and obstetricians relating to induction of labour at term for women over 35 years of age. STUDY DESIGN Cross-sectional web-based survey sent to members of the British Maternal and Fetal Medicine Society (BMFMS) and pregnant or recently delivered members of a large social network site for parents (www.mumsnet.com). One hundred and twenty-eight consultant obstetrician members of BMFMS and 663 pregnant or recently delivered women responded. RESULTS Two hundred and eighty-eight women (43%) would consider induction of labour for maternal age alone, and 192 women (29%) would consider participating in a randomised trial of induction of labour at term versus expectant management in a future pregnancy. Three percent (n=4) of consultant obstetricians offer induction of labour at term to women at 35-39 years of age, 37% (n=47) to women at 40-44 years of age and 55% (n=70) to those over 45 years. Sixty-one consultants (48%) would participate in a trial to test the effect of a policy of induction for nulliparous women over 35 years old. CONCLUSIONS The policy of offering induction of labour at term for advanced maternal age is widespread and a significant percentage of women consider it to be a valid indication.

The dangers of the day of birth

To compare the risk of fetal death on the day of childbirth, with the risk of death at other ages, and with the risks of some hazardous activities, on a common scale of risk per day.

Childbirth experience questionnaire: validating its use in the United Kingdom

BackgroundThe Childbirth Experience Questionnaire (CEQ) was developed in Sweden in 2010 and validated in 920 primiparous women. It has not been validated in the United Kingdom (UK).Measuring the impact of an intervention on a woman’s childbirth experience is arguably as important as measuring its impact on outcomes such as caesarean delivery and perinatal morbidity or mortality and yet surprisingly it is rarely done. The lack of a robust validated tool for evaluating labour experience in the UK is a topical issue in the UK at present. Indeed NICE say ‘A standardised method to measure and quantify womens psychological and emotional wellbeing and their birth experiences is urgently required to support any study investigating the effectiveness of interventions, techniques or strategies during birth.’MethodsThe Childbirth Experience Questionnaire and part of the Care Quality Commission Maternity Survey (2010) was sent to 350 women at one month postnatal. The CEQ was sent again two weeks later. The CEQ was tested for face validity among 25 postnatal mothers. Demographic data and delivery data was used to establish construct validity of the CEQ using the method of known-groups validation. The results of the scored CEQ sent out twice were used to measure test-retest reliability of the CEQ by calculating the quadratic weighted index of agreement between the two scores. Criterion validity was measured by calculating the Pearson correlation coefficient for the CEQ and Maternity Survey scores.ResultsFace validity of the CEQ in a UK population was demonstrated with all respondents stating it was easy to understand and complete. A statistically significantly higher CEQ score for subgroups of women known to report a better birth outcome demonstrated construct validity of the CEQ. A weighted kappa of 0.68 demonstrated test-retest reliability of the CEQ. A Pearson correlation co-efficient of 0.73 demonstrated a strong correlation between the results of the CEQ and the results of the ‘gold standard’ assessment of childbirth experience in the UK: the Maternity Survey and hence criterion validity of the CEQ.ConclusionsThe Childbirth Experience Questionnaire is a valid and reliable measure of childbirth experience in the UK population.

Induction of labour versus expectant management at term by subgroups of maternal age: an individual patient data meta-analysis.

BACKGROUND British women are delaying childbirth. Women aged 35 years or over have a higher risk of perinatal death. There is a linear relationship between maternal age and delivery by emergency caesarean in nulliparous women. Many obstetricians induce older women at term attempting to improve perinatal outcomes, others are reluctant for fear of increasing caesarean rates. A recent systematic review of induction of labour versus expectant management in women at term, found induction was associated with a reduction in caesareans (OR 0.83, 95% CI 0.76-0.92). OBJECTIVES To identify whether induction of labour changes the risk of caesarean section in women aged 35 years or over. STUDY DESIGN SEARCH STRATEGY Available data sets from RCTs included in the Wood et al. systematic review (31 trials) and suitable RCTs published since week 23, 2012. SELECTION CRITERIA Studies were included if they were randomised controlled trials comparing induction of labour with expectant management at term with intact membranes with a singleton or multiple pregnancy in a cephalic presentation. DATA COLLECTION AND ANALYSIS A quantitative meta-analysis of individual patient data (IPD) using a random-effects model to calculate odds ratios. RESULTS In total 2675 women (five studies) were included in the meta-analysis and 2526 women (four studies) were included in the IPD meta-analysis. There was no statistically significant increase in caesarean section rates seen in either analysis. CONCLUSIONS Induction of labour in women of advanced maternal age has no statistically significant effect on caesarean section rates.

Labour induction near term for women aged 35 or over: an economic evaluation

Induction of labour at 39 weeks for nulliparous women aged 35 years and over may prevent stillbirths and does not increase caesarean births, so it may be popular. But the overall costs and benefits of such a policy have not been compared.