Pharmacological pain relief and fear of childbirth in low risk women; secondary analysis of the RAVEL study

Acknowledgements We would like to thank all of the participants in our study and the midwives and gynaecologists of the participating practices and hospitals respectively. Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on request.Peer reviewedPublisher PD

IMproving PArticipation of patients in Clinical Trials - rationale and design of IMPACT

BACKGROUND: One of the most commonly reported problems of randomised trials is that recruitment is usually slower than expected. Trials will cost more and take longer, thus delaying the use of the results in clinical practice, and incomplete samples imply decreased statistical power and usefulness of its results. We aim to identify barriers and facilitators for successful patient recruitment at the level of the patient, the doctor and the hospital organization as well as the organization and design of trials over a broad range of studies. METHODS/DESIGN: We will perform two cohort studies and a case-control study in the Netherlands. The first cohort study will report on a series of multicenter trials performed in a nationwide network of clinical trials in obstetrics and gynaecology. A questionnaire will be sent to all clinicians recruiting for these trials to identify determinants - aggregated at centre level - for the recruitment rate. In a case control-study nested in this cohort we will interview patients who refused or consented participation to identify factors associated with patients' consent or refusal. In a second cohort study, we will study trials that were prospectively registered in the Netherlands Trial Register. Using a questionnaire survey we will assess whether issues on hospital organization, trial organization, planning and trial design were associated with successful recruitment, i.e. 80% of the predefined number of patients recruited within the planned time. DISCUSSION: This study will provide insight in barriers and facilitators for successful patient recruitment in trials. The results will be used to provide recommendations and a checklist for individual trialists to identify potential pitfalls for recruitment and judge the feasibility prior to the start of the study. Identified barriers and motivators coupled to evidence-based interventions can improve recruitment of patients in clinical trials

Influence of gestational age at initiation of antihypertensive therapy: Secondary analysis of CHIPS trial data (control of hypertension in pregnancy study).

For hypertensive women in CHIPS (Control of Hypertension in Pregnancy Study), we assessed whether the maternal benefits of tight control could be achieved, while minimizing any potentially negative effect on fetal growth, by delaying initiation of antihypertensive therapy until later in pregnancy. For the 981 women with nonsevere, chronic or gestational hypertension randomized to less-tight (target diastolic blood pressure, 100 mm Hg), or tight (target, 85 mm Hg) control, we used mixed-effects logistic regression to examine whether the effect of less-tight (versus tight) control on major outcomes was dependent on gestational age at randomization, adjusting for baseline factors as in the primary analysis and including an interaction term between gestational age at randomization and treatment allocation. Gestational age was considered categorically (quartiles) and continuously (linear or quadratic form), and the optimal functional form selected to provide the best fit to the data based on the Akaike information criterion. Randomization before (but not after) 24 weeks to less-tight (versus tight) control was associated with fewer babies with birth weight 48 hours (Pinteraction=0.354). For the mother, less-tight (versus tight) control was associated with more severe hypertension at all gestational ages but particularly so before 28 weeks (Pinteraction=0.076). In women with nonsevere, chronic, or gestational hypertension, there seems to be no gestational age at which less-tight (versus tight) control is the preferred management strategy to optimize maternal or perinatal outcomes

Pregnant womens' concerns when invited to a randomized trial : a qualitative case control study

BACKGROUND: Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific enrolment challenges. Previous studies have focused on barriers to trial participation in studies that had failed to recruit sufficient participants. Our aim was to identify barriers and motivators for participation in a range of clinical trials being conducted in the Netherlands, regardless of recruitment performance. METHODS: We performed a qualitative case control study in women who had been asked in 2010 to participate in one of eight clinical trials during pregnancy or shortly after giving birth. Both participants and non-participants of these clinical trials were invited for a face-to-face interview that addressed motives for participation and non-participation. We started the interview in an open fashion, asking the women for their main motive for participation or non-participation. When no new information emerged in this open part, we continued with a semi-structured interview, guided by a topic list. Transcripts of the interviews were analysed using a constant-comparative approach. Two researchers identified barriers and facilitators for participation, conjoined into main themes. RESULTS: Of 28 women invited for the interview, 21 agreed to be interviewed (12 participants and 9 non-participants). For 5 of the 12 participants, contribution to scientific research was their main motive, while 5 had participated because the intervention seemed favorable and was not available outside the trial. Key motives for non-participation (n = 9) were a negative association or a dislike of the intervention, either because it might do harm (n = 6) or for practical reasons (n = 3). Combining the open and topic list guided interviews we constructed seven main themes that influence the pregnant women's decision to participate: external influence, research and healthcare, perception own situation, study design, intervention, information and counselling, and uncertainty. CONCLUSIONS: Among seven main themes that influence pregnant women's decision to participate, uncertainty about scientific research or the intervention was reported to be of considerable importance. Measures should be taken to habituate pregnant women more to scientific research, and further evaluation of opt-out consent deserves attention

Additional file 1: of Pregnant womens’ concerns when invited to a randomized trial: a qualitative case control study

Topic list to guide the interview. (ZIP 13 kb

Praktijkvariatie in het gebruik van remifentanil tijdens de partus: Een beeld van de toepassing in de Nederlandse ziekenhuizen = [Practice application of remifentanil during labor: An overview of its application in Dutch hospitals]

DoelOnderzoeken (a) frequentie van het gebruik van patiëntgecontroleerde toediening van remifentanil (remifentanil-PCA) durante partu in Nederland; (b) wat motieven zijn om remifentanil-PCA al dan niet aan te bieden; (c) voor welke vrouwen remifentanil-PCA beschikbaar is; en (d) welke maternale monitoring wordt toegepast.OpzetBeschrijvend vragenlijstonderzoek.MethodeAlle 81 Nederlandse ziekenhuizen met een verlosafdeling ontvingen een vragenlijst over de volgende onderwerpen: (a) beschikbare methoden voor farmacologische pijnbehandeling; (b) motieven van gynaecologen om remifentanil-PCA wel of niet aan te bieden; (c) de doelgroep voor remifentanil-PCA; (d) maternale monitoring; en (e) Perined-gegevens uit 2016. Wij vroegen de ziekenhuisapothekers naar aantallen ampullen remifentanil die zij in de periode 2016-2017 geleverd hadden.ResultatenDe vragenlijst werd door 81 gynaecologen (100%) ingevuld. In 59 (73%) van de 81 ziekenhuizen was remifentanil-PCA beschikbaar. In deze ziekenhuizen werd remifentanil-PCA bij gemiddeld 23% van de partussen toegepast (uitersten: 16-56%). In 34 (58%) van deze 59 ziekenhuizen was remifentanil-PCA voor alle vrouwen beschikbaar en in 25 (42%) voor een selecte groep. De meest genoemde motieven om remifentanil-PCA beschikbaar te stellen waren ‘de wenselijkheid van een alternatief voor epidurale analgesie’ en ‘op verzoek van zwangeren’, respectievelijk 55 keer (93%) en 46 keer (78%). In ziekenhuizen waar remifentanil-PCA niet beschikbaar was, waren ‘betere pijnbehandeling door epidurale analgesie’, ‘het risico op ernstige maternale bijwerkingen’ en ‘onvoldoende mogelijkheden voor observatie op verloskamers’ de belangrijkste motieven voor dit beleid.ConclusieEr is aanzienlijke variatie in de toepassing van remifentanil-PCA durante partu in Nederland. Remifentanil-PCA is in het merendeel van de ziekenhuizen beschikbaar voor alle vrouwen. De belangrijkste motieven van gynaecologen zijn ‘de wenselijkheid van een alternatief voor epidurale analgesie’ en ‘op verzoek van zwangeren’

Praktijkvariatie in het gebruik van remifentanil tijdens de partus: Een beeld van de toepassing in de Nederlandse ziekenhuizen = [Practice variation in the application of remifentanil during labour: an overview of its application in Dutch hospitals]

Objective: To survey (a) the frequency of the use of patient-controlled analgesic remifentanil-PCA during labour in the Netherlands; (b) considerations by obstetricians whether or not to offer remifentanil-PCA; (c) target population for remifentanil-PCA and (d) the application of maternal monitoring.Design: Descriptive survey.Method: A questionnaire was sent to all 81 Dutch hospitals with a labour ward. The following subjects were covered: (a) available methods for pharmacological pain relief; (b) considerations by obstetricians whether or not to offer remifentanil-PCA; (c) target population for remifentanil-PCA; (d) maternal monitoring and (e) the hospital's birth data for the year 2016. The hospital pharmacist was asked for the number of remifentanil dispensed in 2016-2017.Results: The questionnaire was completed by 81 obstetricians (100% response rate). Remifentanil-PCA was available in 59 out of 81 (73%) of the hospitals with a mean use of 23% of the births (range 16-56%) in those units. In 34 (58%) of these hospitals, remifentanil-PCA is available for all women, and in 25 (42%) it was for a selected group of women. Most frequently mentioned considerations for offering remifentanil-PCA were 'a need for an alternative for epidural analgesia' and 'at the request of pregnant women' reported a respective 55 (93%) and 46 (78%) times. In hospitals where remifentanil-PCA was not offered, the following motives were given for this policy: 'epidural analgesia is the most effective method of pain relief during labour'; 'risk of serious maternal complications'; and 'sufficient monitoring during labour not feasible in delivery rooms'.Conclusion: A large variation between Dutch hospitals exists in the application of remifentanil-PCA during labour. In the majority of the hospitals, remifentanil-PCA is available for all women. The most common motives mentioned by obstetricians for its use are 'a need for an alternative for epidural analgesia' and 'at the request of pregnant women'

Does measurement of intrauterine pressure have predictive value during oxytocin-augmented labor?

In a previous randomized trial that compared monitoring uterine contractions with an intrauterine pressure catheter (IUPC) versus external monitoring, we demonstrated that use of an IUPC did not improve the outcome of labor. To provide insight in the lack of a positive effect, we evaluated level of IUP in Montevideo units (MU) in correlation with dysfunctional labor and adverse neonatal outcome. Here, we present two secondary analyses on the 503 women who had IUP measured in the trial. Firstly, we assessed labor outcome in relation to the highest IUP measured at any time during labor. Secondly, we assessed labor outcome to the IUP registered at the last vaginal examination during the first stage of labor in two study groups (above and below 200 MU). Women with lower IUP were statistically significant older, had pregnancies with a longer gestational age, longer labors and neonates with a higher birth weight. The risk of a cesarean section was higher in women who had low IUP during labor (Likelihood Ratio 1.6 for IUP   300 MU). IUP was not associated with neonatal outcome. IUP is associated with mode of delivery. However, use of internal tocodynamometry does not improve birth outcome