Correction: Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia between 34 and 37 weeks' gestation (HYPITAT-II): a multicentre, open-label randomised controlled trial

Kim Broekhuijsen, Josje Langenveld, Gert-Jan van Baaren, Mariëlle G van Pampus, Anton H van Kaam, Henk Groen, Martina Porath, Maureen TM Franssen, Ben W Mol, and HYPITAT-II study grou

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 versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term

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 versus expectant monitoring for intrauterine growth restriction at term: Randomised equivalence trial (DIGITAT)

Objective: To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. Design: Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). Setting: Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008. Participants: Pregnant women who had a singleton pregnancy beyond 36+0 weeks' g

Development and validation of a questionnaire to identify severe maternal morbidity in epidemiological surveys

<p>Abstract</p> <p>Objective</p> <p>to develop and validate a questionnaire on severe maternal morbidity and to evaluate the maternal recall of complications related to pregnancy and childbirth. <it>Design: </it>validity of a questionnaire as diagnostic instrument. <it>Setting: </it>a third level referral maternity in Campinas, Brazil. <it>Population: </it>386 survivors of severe maternal complications and 123 women that delivered without major complications between 2002 and 2007.</p> <p>Methods</p> <p>eligible women were traced and interviewed by telephone on the occurrence of obstetric complications and events related to their treatment. Their answers were compared with their medical records as gold standard. Sensitivity, specificity and likelihood ratios plus their correspondent 95% confidence intervals were used as main estimators of accuracy. <it>Main outcomes: </it>diagnosis of severe maternal morbidity associated with past pregnancies, including hemorrhage, eclampsia, infections, jaundice and related procedures (hysterectomy, admission to ICU, blood transfusion, laparotomy, inter-hospital transfer, mechanical ventilation and post partum stay above seven days).</p> <p>Results</p> <p>Women did not recall accurately the occurrence of obstetric complications, especially hemorrhage and infection. The likelihood ratios were < 5 for hemorrhage and infection, while for eclampsia it almost reached 10. The information recalled by women regarding hysterectomy, intensive care unit admission and blood transfusion were found to be highly correlated with finding evidence of the event in the medical records (likelihood ratios ranging from 12.7-240). The higher length of time between delivery and interview was associated with poor recall.</p> <p>Conclusion</p> <p>Process indicators are better recalled by women than obstetric complication and should be considered when applying a questionnaire on severe maternal morbidity.</p

Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial

Contains fulltext : 79491.pdf (publisher's version ) (Open Access)BACKGROUND: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. METHODS/DESIGN: We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80. DISCUSSION: This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies. TRIAL REGISTRATION: Current Controlled Trials: NTR 1858

Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial)

Contains fulltext : 80242.pdf (publisher's version ) (Open Access)BACKGROUND: Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. METHODS/DESIGN: The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, beta 0.2 at alpha 0.05). DISCUSSION: This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. TRIAL REGISTRATION: Clinical trial registration: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008

Development and measurement of guidelines-based quality indicators of caesarean section care in the Netherlands: A RAND-modified delphi procedure and retrospective medical chart review

Background There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates. Method Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery. Results The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adh