Risk of operative delivery for intrapartum fetal compromise in small-for-gestational-age fetuses at term: external validation of the IRIS algorithm.

OBJECTIVES: Small-for-gestational-age fetuses (SGA) are at high risk of intrapartum fetal compromise requiring operative delivery. In a recent study, we developed a model using a combination of three antenatal (gestational age at delivery, parity, cerebroplacental ratio) and three intrapartum (epidural use, labor induction and augmentation using oxytocin) variables for the prediction of operative delivery due to presumed fetal compromise in SGA fetuses - the Individual RIsk aSsessment (IRIS) prediction model. The aim of this study was to test the predictive accuracy of the IRIS prediction model in an external cohort of singleton pregnancies complicated by SGA. METHODS: This was an external validation study using a cohort of pregnancies from two tertiary referral centers in Spain and England. The inclusion criteria were singleton pregnancies diagnosed with an SGA fetus, defined as estimated fetal weight (EFW) below the 10th centile for gestational age at 36 weeks or beyond, which had fetal Doppler assessment and available data on their intrapartum care and pregnancy outcomes. The main outcome in this study was the operative delivery for presumed fetal compromise. External validation was performed using the coefficients obtained in the original development cohort. The predictive accuracies of models were investigated with receiver operating characteristics (ROC) curves. The Hosmer-Lemeshow test was used to test the goodness-of-fit of models and calibration plots were also obtained for visual assessment. A mobile application using the combined model algorithm was developed to facilitate clinical use. RESULTS: Four hundred twelve singleton pregnancies with an antenatal diagnosis of SGA were included in the study. The operative delivery rate was 22.8% (n = 94). The group which required operative delivery for presumed fetal compromise had significantly fewer multiparous women (19.1 versus 47.8%, p < 0.001 in the total study population; 19.0 versus 43.5 and 19.2 versus 49.6%, UK and Spain cohort, respectively), lower cerebroplacental ratio (CPR) multiples of median (MoM) (median: 0.77 versus 0.92, p < 0.001 in the total study population; 0.77 versus 0.92 and 0.77 versus 0.92, UK and Spain cohort, respectively), more inductions of labor (74.5 versus 60.1%, p = 0.010 in the total study population; 85.7 versus 77.2 and 71.2% and 53.1, UK and Spain cohort, respectively) and more use of oxytocin augmentation (57.4 versus 39.3%, p = 0.002 in the total study population; 19.0 versus 12.0 and 68.5 and 50.4%, UK and Spain cohort, respectively) compared to those who did not require operative delivery due to presumed fetal compromise. When the original antenatal model was applied to the present cohort, we observed moderate predictive accuracy (AUC: 0.70, 95% CI: 0.64-0.76), and no signs of poor fit (p = 0.464). The original combined model, when applied to the external cohort, had moderate predictive accuracy (AUC: 0.72, 95% CI: 0.67-0.77) and also no signs of poor fit (p = 0.268) without the need for refitting. A statistically significant increase in the predictive accuracy was not achieved via refitting of the combined model (AUC 0.76 versus 0.72, p = 0.060). CONCLUSIONS: Using our recently published model, the predictive accuracy for fetal compromise requiring operative delivery in term fetuses thought to be SGA was modest and showed no signs of poor fit in an external cohort. The IRIS tool for mobile devices has been developed to facilitate wide clinical use of this prediction model

The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial

Background The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. Methods/design Women in established labour, requesting systemic opioid pain relief, will be randomised to either intravenously administered remifentanil PCA (intervention) or pethidine intramuscular injection (control) in an unblinded, 1:1 individual randomised trial. Following informed consent, 400 women in established labour, who request systemic opioid pain relief, from NHS Trusts across England will undergo a minimised randomisation by a computer or automated telephone system to either pethidine or remifentanil. In order to balance the groups this minimisation is based on four parameters; parity (nulliparous versus multiparous), maternal age (<20, 20 < 30, 30 < 40, 40+ years), ethnicity (South Asian (Pakistani/Indian/Bangladeshi) versus Other) and induced versus spontaneous labour. The effectiveness of pain relief provided by each technique will be recorded every 30 min after time zero, until epidural placement, delivery or transfer to theatre, quantified by Visual Analogue Scale. Incidence of maternal side effects including sedation, delivery mode, foetal distress requiring delivery, neonatal status at delivery and rate of initiation of breastfeeding within the first hour of birth will also be recorded. Maternal satisfaction with her childbirth experience will be determined by a postpartum questionnaire prior to discharge from the delivery ward. Discussion The RESPITE trial’s primary outcome is the proportion of women who have an epidural placed for pain relief in labour in each arm. Trial Registration Current Controlled Trials registration number: ISRCTN29654603. Registered on 23 July 2013

Evaluation of satisfaction with care in a midwifery unit and an obstetric unit: a randomized controlled trial of low-risk women

Publisher's version, source: http://doi.org/10.1186/s12884-016-0932-x.BACKGROUND Satisfaction with birth care is part of quality assessment of care. The aim of this study was to investigate possible differences in satisfaction with intrapartum care among low-risk women, randomized to a midwifery unit or to an obstetric unit within the same hospital. METHODS Randomized controlled trial conducted at the Department of Obstetrics and Gynecology, Østfold Hospital Trust, Norway. A total of 485 women with no expressed preference for level of birth care, assessed to be at low-risk at onset of spontaneous labor were included. To assess the overall satisfaction with intrapartum care, the Labour and Delivery Satisfaction Index (LADSI) questionnaire, was sent to the participants 6 months after birth. To assess women’s experience with intrapartum transfer, four additional items were added. In addition, we tested the effects of the following aspects on satisfaction; obstetrician involved, intrapartum transfer from the midwifery unit to the obstetric unit during labor, mode of delivery and epidural analgesia. RESULTS Women randomized to the midwifery unit were significantly more satisfied with intrapartum care than those randomized to the obstetric unit (183 versus 176 of maximum 204 scoring points, mean difference 7.2, p = 0.002). No difference was found between the units for women who had an obstetrician involved during labor or delivery and who answered four additional questions on this aspect (mean item score 4.0 at the midwifery unit vs 4.3 at the obstetric unit, p = 0.3). Intrapartum transfer from the midwifery unit to an obstetric unit, operative delivery and epidurals influenced the level of overall satisfaction in a negative direction regardless of allocated unit (p < 0.001). CONCLUSION Low-risk women with no expressed preference for level of birth care were more satisfied if allocated to the midwifery unit compared to the obstetric unit. TRIAL REGISTRATION The trial is registered at www.​clinicaltrials.​gov NCT00857129. Initially released 03/05/2009

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

Contains fulltext : 109349.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND: Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. METHODS/DESIGN: The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. DISCUSSION: This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR2551, http://www.trialregister.nl