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

BACKGROUND: Fear of childbirth may reduce the womens' pain tolerance during labour and may have impact on the mother-infant interaction. We aimed to assess (1) the association between fear of childbirth antepartum and subsequent request for pharmacological pain relief, and (2) the association between the used method of pain relief and experienced fear of childbirth as reported postpartum in low risk labouring women. METHODS: Secondary analysis of the RAVEL study, a randomised controlled trial comparing remifentanil patient controlled analgesia (PCA) and epidural analgesia to relieve labour pain. The RAVEL study included 409 pregnant women at low risk for obstetric complications at 18 midwifery practices and six hospitals in The Netherlands (NTR 3687). We measured fear of childbirth antepartum and experienced fear of childbirth reported postpartum, using the Wijma Delivery Expectancy/Experience Questionnaire. RESULTS: Women with fear of childbirth antepartum more frequently requested pain relief compared to women without fear of childbirth antepartum, but this association did not reach statistical significance (adjusted odds ratio (aOR2.0; 95% confidence interval (CI) 0.8-4.6). Women who received epidural analgesia more frequently reported fear of childbirth postpartum compared to women who did not receive epidural analgesia (aOR3.5; CI 1.5-8.2), while the association between remifentanil-PCA and fear of childbirth postpartum was not statistically significant (aOR1.7; CI 0.7-4.3). CONCLUSIONS: Women with fear of childbirth antepartum more frequently requested pain relief compared to women without fear of childbirth antepartum, but this association was not statistically significant. Women who received pharmacological pain relief more frequently reported that they had experienced fear of childbirth during labour compared to women who did not receive pain relief. Based on our data epidural analgesia with continuous infusion does not seem to be preferable over remifentanil-PCA as method of pain relief when considering fear of childbirth postpartum. TRIAL REGISTRATION: Netherlands Trial Register 3687 ; Register date: 5 Nov 2012.

[Practice variation in the application of remifentanil during labour; an overview of its application in Dutch hospitals]. / Praktijkvariatie in het gebruik van remifentanil tijdens de partus.

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?

OBJECTIVE: 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. STUDY DESIGN: 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). RESULTS: 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 < 100 MU, 0.41 for IUP > 300 MU). IUP was not associated with neonatal outcome. CONCLUSION: IUP is associated with mode of delivery. However, use of internal tocodynamometry does not improve birth outcomes.

Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial.

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 (SpO2 <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. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia. TRIAL REGISTRATION: Netherlands Trial Register NTR2551.

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.