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Objective To determine women’s satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. Intervention Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. Main outcome measures Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. Results 1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference −2.8, 95% confidence interval −6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference −10.4, −13.9 to −7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO 2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups. Conclusion In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief...

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Objectives The combination of prolapse surgery with an incontinence procedure can reduce the incidence of stress urinary incontinence (SUI) after surgery, but may increase adverse events. We compared the effectiveness and safety of prolapse surgery versus combined prolapse and incontinence surgery in women with pelvic organ prolapse.Design and setting Pubmed, EMBASE, DARE, the Cochrane Library and the register of Current Controlled Trials were searched for randomised trials (restricted to Burch colposuspension and midurethral sling as incontinence procedure) from 1995 to 2013 limited to the English literature.Methods Two reviewers selected eligible articles and extracted the data. Pooling for SUI was based on three patient groups: (1) women with coexisting SUI; (2) women asymptomatic for SUI; and (3) women with occult SUI. For adverse events, pooling was based on incontinence procedure.Main outcome measures The primary outcome was SUI. The secondary outcomes were treatment for SUI, bladder storage symptoms, obstructive voiding and adverse events.Results Seven trials were included. Pooling for women with coexisting SUI was possible for objective SUI with two studies and showed no difference. Statistical (I 2 = 95%) and clinical heterogeneity was, however, high. The largest study showed a lower incidence of persisting SUI (5% versus 23%) and treatment for this (0% versus 57%) in women who underwent prolapse repair with a midurethral sling. The second study did not find a difference in women undergoing a sacrocolpopexy with or without Burch colposuspension. In asymptomatic women, combination surgery resulted in a lower incidence of de novo subjective SUI (two studies; 24% versus 41%; relative risk [RR], 0.6; 95% confidence interval [CI], 0.3-0.9; I 2 = 36%) and the need for subsequent anti-incontinence surgery (three studies; 2% versus 7%; RR, 0.4; 95% CI, 0.2-0.8; I 2 = 13%). For the outcome objective SUI, pooling was possible for five studies, but statistical heterogeneity was high (I 2 = 82%) and the difference was not statistically significant. In the subgroup of women with occult stress incontinence, we found a lower incidence of objective SUI after combination surgery (two studies; 22% versus 52%; RR, 0.4; 95% CI, 0.3-0.8; I 2 = 32%). There were no differences in bladder storage symptoms, urgency incontinence or long-term obstructive voiding symptoms. Adverse events (two studies; 15% versus 10%; RR, 1.6; 95% CI, 1.0-2.5; I 2 = 0%) and prolonged catheterisation (three studies; 6% versus 1%; RR, 4.5; 95% CI, 1.5-13.3; I 2 = 0%)were more frequent after vaginal prolapse repair with a midurethral sling.Conclusions Combination surgery reduces the risk of postoperative stress incontinence, but short-term voiding difficulties and adverse events were more frequent after combination surgery with a midurethral sling.Keywords Burch colposuspension, meta-analysis, midurethral sling, pelvic organ prolapse, review, stress urinary incontinence.Please cite this paper as: van der Ploeg JM, van der Steen A, Oude Rengerink K, va...

Introduction and hypothesisPostpartum urinary retention (PUR) is a common consequence of bladder dysfunction after vaginal delivery. Patients with covert PUR are able to void spontaneously but have a postvoid residual bladder volume (PVRV) of ≥150 mL. Incomplete bladder emptying may predispose to bladder dysfunction at a later stage of life. The aim of this cross-sectional study was to identify independent delivery-related risk factors for covert PUR after vaginal delivery in order to identify women with an increased risk of covert PUR.MethodsThe PVRV of women who delivered vaginally was measured after the first spontaneous micturition with a portable bladder-scanning device. A PVRV of 150 mL or more was defined as covert PUR. Independent risk factors for covert PUR were identified in multivariate regression analysis.ResultsOf 745 included women, 347 (47 %) were diagnosed with covert PUR (PVRV ≥150 mL), of whom 197 (26 %) had a PVRV ≥250 mL (75th percentile) and 50 (7 %) a PVRV ≥500 mL (95th percentile). In multivariate regression analysis, episiotomy (OR 1.7, 95 % CI 1.02 – 2.71), epidural analgesia (OR 2.08, 95 % CI 1.36 – 3.19) and birth weight (OR 1.03, 95 % CI 1.01 – 1.06) were independent risk factors for covert PUR. Opioid analgesia during labour (OR 3.19, 95 % CI 1.46 – 6.98), epidural analgesia (OR 3.54, 95 % CI 1.64 – 7.64) and episiotomy (OR 3.72, 95 % CI 1.71 – 8.08) were risk factors for PVRV ≥500 mL.ConclusionsEpisiotomy, epidural analgesia and birth weight are risk factors for covert PUR. We suggest that the current cut-off values for covert PUR should be reevaluated when data on the clinical consequences of abnormal PVRV become available.

ObjectiveTo compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect.DesignMulticentre randomised controlled trial.SettingEleven hospitals collaborating in a consortium for women's health research in the Netherlands.PopulationWomen reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of ≥3 mm, measured during sonohysterography.MethodsWomen were randomly allocated to hysteroscopic niche resection or expectant management for 6 months.Main outcome measuresThe primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation.ResultsWe randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2–7 days) in the intervention group and 7 days (IQR 3–10 days) in the control group (P = 0.04); on a scale of 0–10, discomfort as a result of spotting had a median score of 2 (IQR 0–7) in the intervention group, compared with 7 (IQR 0–8) in the control group (P = 0.02).ConclusionsIn women with a niche with a residual myometrium of ≥3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting‐related discomfort.Tweetable abstractA hysteroscopic niche resection is an effective treatment to reduce niche‐related spotting.

BackgroundA caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection.Methods/DesignWe planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months.The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation.DiscussionThis trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection.Trial registrationDutch Trial Register NTR3269. Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030

BackgroundSince pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling “scientific reasons” for their exclusion. However, it is questionable whether this approach renders research with pregnant women fair. This paper analyzes and evaluates when research with pregnant women can be considered as fair and what constitutes scientific reasons for exclusion.MethodsConceptual ethical and methodological analysis and evaluation of fair inclusion.ResultsFair inclusion of pregnant women means (1) that pregnant women who are eligible are not excluded solely for being pregnant and (2) that the research interests of pregnant women are prioritized, meaning that they ought to receive substantially more attention. Fairness does not imply that pregnant women should be included in virtually every research project, as including only a few pregnant women in a population consisting only of women will not help to determine the effectiveness and safety of a treatment in pregnant women. Separate trials in pregnant women may be preferable once we assume, or know, that effects of interventions in pregnant women differ from the effects in other subpopulations, or when we assume, or know, that there are no differences. In the latter case, it may be preferable to conduct post-marketing studies or establish registries. If there is no conclusive evidence indicating either differences or equivalence of effects between pregnant and non-pregnant women, yet it seems unlikely that major differences or exact equivalence exist, the inclusion of pregnant women should be sufficient. Depending on the research question, this boils down to representativeness in terms of the proportion of pregnant and non-pregnant women, or to oversampling pregnant women.ConclusionsFair inclusion of pregnant women in research implies that separate trials in pregnant women should be promoted. Inclusion of pregnant women has to be realized at the earliest phases of the research process. In addition to researchers and research ethics committees, scientific advisory councils, funders, drug regulatory agencies, pharmaceutical companies, journal editors and others have a joint responsibility to further develop the evidence base for drug use in pregnant women.