Liever inleiden dan afwachten bij aterme zwangerschapshypertensie en milde preeclampsie: HYPITAT-studie

OBJECTIVE: To investigate what would benefit women with mild full-term pregnancy-related hypertension most: induction of labour or expectant monitoring, from the perspective of clinical effectiveness, maternal quality of life, and costs. DESIGN: Randomised clinical trial. Trial registration number ISRCTN08132825. METHODS: We undertook a multicentre randomised controlled trial in 38 hospitals in the Netherlands between October 2005 and March 2008. We enrolled patients with a singleton pregnancy in cephalic presentation at 36-41 weeks' gestation, who had gestational hypertension or mild preeclampsia. Participants were randomly allocated to receive either induction of labour or expectant monitoring. The primary outcome was a composite measure of poor maternal outcome, defined as maternal mortality, maternal morbidity (eclampsia, 'haemolysis, elevated liver enzymes, low platelets' (HELLP) syndrome, pulmonary oedema, thrombo-embolic disease and abruptio placentae), progression to severe hypertension or proteinuria, and major postpartum haemorrhage. Secondary outcomes were mode of delivery, neonatal outcome, maternal quality of life and costs. Analysis was by intention to treat. RESULTS: A total of 756 patients were allocated to receive induction of labour (n = 377 patients) or expectant monitoring (n = 379). No cases of maternal or neonatal death or eclampsia were recorded. Development of poor maternal outcome was significantly lower in the induction of labour group (117 women) than the expectant monitoring group (166 women) (31% versus 44%; relative risk 0.71 (95% CI: 0.59-0.86); p < 0.001). The caesarean section rate was lower among women in the induction of labour group (n = 54) compared to women in the expectant monitoring group (n = 72) (14% versus 19%; relative risk 0.75 (95% CI: 0.55-1.04)< p = 0.085). Neonatal outcomes and quality of life were comparable between both groups. Induction of labour is a cost saving strategy (difference euro 831). CONCLUSION: For women with full-term gestational hypertension and pre-eclampsia, induction of labour is associated with improved maternal outcome and lower costs, without the additional risk of a caesarean section being necessary

Induction of labor with a Foley catheter and the risk of subsequent preterm birth: A follow-up study of two randomized controlled trials (PROBAAT-1 and -2)

OBJECTIVE:The objective of this study was to evaluate the preterm birth rate in a subsequent pregnancy in women who had undergone term induction with a Foley catheter in comparison to induction with prostaglandins. METHODS:This was a follow-up study of two large randomized controlled trials. In the original trials (PROBAAT-1 and PROBAAT-2), women with a term, singleton pregnancy in cephalic presentation with an indication for labor induction were randomized to either a 30cc Foley catheter or prostaglandins (i.e. vaginal prostaglandin E2 in PROBAAT 1 and oral misoprostol in PROBAAT 2). The main outcome measures were preterm birth <37 weeks gestation and preterm birth <34 weeks gestation. Data were collected from hospital charts on subsequent pregnancies from hospitals participating in this follow-up study. RESULTS:14 hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 162 women (14%) were lost to follow-up. Of the 572 women randomized to a Foley catheter, 251 women had a subsequent pregnancy beyond 16 weeks gestation, versus 258 women of the 570 women who received prostaglandins. There were no differences in baseline characteristics. The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93; 95%CI 0.38-2.24), with spontaneous preterm birth rates of 5/251 (2.0%) versus 5/258 (1.9%) respectively (RR 1.03, 95%CI 0.30-3.51). CONCLUSIONS:In women with a singleton term pregnancy, induction of labor with a 30cc Foley catheter is not associated with an increased risk of preterm birth in a subsequent pregnancy as compared to induction of labor with prostaglandins. This article is protected by copyright. All rights reserved.M. D. T. de Vaan, D. Blel, K. W. M. Bloemenkamp, M. Jozwiak, M. L. G. ten Eikelder ... B. W. Mol ... et al

Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial

Objective, To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version, ECV, for breech presentation. Design, Multicentre, open label, randomised controlled trial. Setting, Eight hospitals in the Netherlands, August, to May, . Participants, women with a singleton fetus in breech presentation and a gestational age of more than, weeks were randomly allocated in a, ratio to either, ., mg atosiban, n, or, μg fenoterol, n, intravenously for uterine relaxation before ECV. Main outcome measures, The primary outcome measures were a fetus in cephalic position, minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis. Results, Cephalic position, minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group, v, relative risk, ., confidence interval, ., to, ., . Presentation at birth was cephalic in, n, of the atosiban group and, n, of the fenoterol group, ., ., to, ., and caesarean delivery was performed in, n, of women in the atosiban group and, n, in the fenoterol group, ., ., to, ., . No significant differences were found in neonatal outcomes or drug related adverse events. Conclusions, In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation, minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.Joost Velzel, Floortje Vlemmix, Brent C Opmeer, Jan F M Molkenboer, Corine J Verhoeven, Mariëlle G van Pampus, Dimitri N M Papatsonis, Joke M J Bais, Karlijn C Vollebregt, Liesbeth van der Esch, Joris A M Van der Post, Ben Willem Mol, Marjolein Ko

Induction of labor with Foley catheter and risk of subsequent preterm birth: follow-up study of two randomized controlled trials (PROBAAT-1 and -2)

Objective: To evaluate the rate of preterm birth (PTB) in a subsequent pregnancy in women who had undergone term induction using a Foley catheter compared with prostaglandins. Methods: This was a follow-up study of two large randomized controlled trials (PROBAAT-1 and PROBAAT-2). In the original trials, women with a term singleton pregnancy with the fetus in cephalic presentation and with an indication for labor induction were randomized to receive either a 30-mL Foley catheter or prostaglandins (vaginal prostaglandin E2 in PROBAAT-1 and oral misoprostol in PROBAAT-2). Data on subsequent ongoing pregnancies > 16 weeks’ gestation were collected from hospital charts from clinics participating in this follow-up study. The main outcome measure was preterm birth 16 weeks' gestation in the Foley catheter and prostaglandin groups, respectively. There were no differences in baseline characteristics between the groups. The overall rate of PTB in a subsequent pregnancy was 9/251 (3.6%) in the Foley catheter group vs 10/258 (3.9%) in the prostaglandin group (relative risk (RR), 0.93; 95% CI, 0.38–2.24), and the rate of spontaneous PTB was 5/251 (2.0%) vs 5/258 (1.9%) (RR, 1.03; 95% CI, 0.30–3.51). Conclusion: In women with term singleton pregnancy, induction of labor using a 30-mL Foley catheter is not associated with an increased risk of PTB in a subsequent pregnancy, as compared to induction of labor using prostaglandins

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

Well being of obstetric patients on minimal blood transfusions (WOMB trial)

Background: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, whic

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

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.Liv M Freeman, Kitty WM Bloemenkamp, Maureen TM Franssen, Dimitri NM Papatsonis, Petra J Hajenius, Marloes E van Huizen, Henk A Bremer, Eline SA van den Akker, Mallory D Woiski, Martina M Porath, Erik van Beek, Nico Schuitemaker, Paulien CM van der Salm, Bianca F Fong, Celine Radder, Caroline J Bax, Marko Sikkema, M Elske van den Akker-van Marle, Jan MM van Lith, Enrico Lopriore, Renske J Uildriks, Michel MRF Struys, Ben Willem J Mol, Albert Dahan, and Johanna M Middeldor

Evidence for perinatal and child health care guidelines in crisis settings: can Cochrane help?

<p>Abstract</p> <p>Background</p> <p>It is important that healthcare provided in crisis settings is based on the best available research evidence. We reviewed guidelines for child and perinatal health care in crisis situations to determine whether they were based on research evidence, whether Cochrane systematic reviews were available in the clinical areas addressed by these guidelines and whether summaries of these reviews were provided in Evidence Aid.</p> <p>Methods</p> <p>Broad internet searches were undertaken to identify relevant guidelines. Guidelines were appraised using AGREE and the clinical areas that were relevant to perinatal or child health were extracted. We searched The Cochrane Database of Systematic Reviews to identify potentially relevant reviews. For each review we determined how many trials were included, and how many were conducted in resource-limited settings.</p> <p>Results</p> <p>Six guidelines met selection criteria. None of the included guidelines were clearly based on research evidence. 198 Cochrane reviews were potentially relevant to the guidelines. These reviews predominantly addressed nutrient supplementation, breastfeeding, malaria, maternal hypertension, premature labour and prevention of HIV transmission. Most reviews included studies from developing settings. However for large portions of the guidelines, particularly health services delivery, there were no relevant reviews. Only 18 (9.1%) reviews have summaries in Evidence Aid.</p> <p>Conclusions</p> <p>We did not identify any evidence-based guidelines for perinatal and child health care in disaster settings. We found many Cochrane reviews that could contribute to the evidence-base supporting future guidelines. However there are important issues to be addressed in terms of the relevance of the available reviews and increasing the number of reviews addressing health care delivery.</p

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.L.M. Freeman, K.W. Bloemenkamp, M.T. Franssen, D.N. Papatsonis, P.J. Hajenius, M.W. Hollmann, M.D. Woiski, M. Porath, H.J. van den Berg, E. van Beek, O.W.H.M. Borchert, N. Schuitemaker, J.M. Sikkema, A.H.M. Kuipers, S.L.M. Logtenberg, P.C.M van der Salm, K.O. Rengerink, E. Lopriore, M.E. van den Akker-van Marle, S. le Cessie, J.M van Lith, M.M. Struys, B.W.J. Mol, A. Dahan, J.M. Middeldor