Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial.

BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 µg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466. FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. FUNDING: FondsNutsOhra.

Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial).

OBJECTIVE: To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DESIGN: Economic analysis based on a randomized clinical trial. SETTING: Obstetric departments of eight academic and 52 non-academic hospitals in the Netherlands. POPULATION: Women with PPROM near term who were not in labor 24 h after PPROM. METHODS: A cost-minimization analysis was done from a health care provider perspective, using a bottom-up approach to estimate resource utilization, valued with unit-costs reflecting actual costs. MAIN OUTCOME MEASURES: Primary health outcome was the incidence of neonatal sepsis. Direct medical costs were estimated from start of randomization to hospital discharge of mother and child. RESULTS: Induction of labor did not significantly reduce the probability of neonatal sepsis [2.6% vs. 4.1%, relative risk 0.64 (95% confidence interval 0.25-1.6)]. Mean costs per woman were €8094 for induction and €7340 for expectant management (difference €754; 95% confidence interval -335 to 1802). This difference predominantly originated in the postpartum period, where the mean costs were €5669 for induction vs. €4801 for expectant management. Delivery costs were higher in women allocated to induction than in women allocated to expectant management (€1777 vs. €1153 per woman). Antepartum costs in the expectant management group were higher because of longer antepartum maternal stays in hospital. CONCLUSIONS: In women with pregnancies complicated by PPROM near term, induction of labor does not reduce neonatal sepsis, whereas costs associated with this strategy are probably higher.

Does training of the nondominant upper extremity reduce the surgeon's muscular strain during laparoscopy?: Results from a randomized controlled trial.

INTRODUCTION: In laparoscopy, suboptimal ergonomics frequently lead to morbidity for surgeons. Physical complaints are more commonly reported on the dominant upper extremity. This may be the consequence of challenging laparoscopic tasks being easier to perform with the dominant side. The authors hypothesized that specific training of the nondominant upper extremity may equip this side better and lead to a more equal distribution of physical load. MATERIALS AND METHODS: Participants (medical doctors) were randomized to a 3-week training schedule or no training. The training program consisted of training the nondominant upper extremity. Participants were not allowed to train on a laparoscopic box or virtual reality trainer during the study period. Baseline and outcome measurements after 3 weeks were examined with the use of EMG measurements during a validated task on a laparoscopic box trainer. Muscle strain of the trapezius and deltoid muscles and effective alternation of brachioradial and abductor pollicis brevis muscles were used as outcome variables. RESULTS: In all, 26 participants were included. EMG analysis revealed that participants in both intervention and control groups showed a decrease in muscle strain of trapezius and deltoid muscles. However, there were no significant differences between groups. Those in the intervention group showed significantly better alternation in the brachioradial muscle. CONCLUSION: Training the nondominant upper extremity leads to better alternated use of lower-arm muscles during a validated box trainer task. Repeating the task after 3 weeks led to less muscle tension in the trapezius and deltoid muscles.

Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial.

BACKGROUND: At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term. METHODS AND FINDINGS: We conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34(+0) and 37(+0) wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM. CONCLUSIONS: In women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM. TRIAL REGISTRATION: Current Controlled Trials ISRCTN29313500

A randomized trial of training the non-dominant upper extremity to enhance laparoscopic performance.

INTRODUCTION: In laparoscopy, the surgeon's dominant arm will execute difficult tasks with less effort compared to the non-dominant arm. This leads to a relative overuse of muscles on this side. We hypothesized that training the non-dominant arm would improve laparoscopic skills. MATERIAL AND METHODS: At baseline, all participants performed three validated tasks on a virtual reality simulator. After randomization, subjects in the intervention group were assigned training tasks. All these tasks had to be performed with the non-dominant hand. Within a week after a three-week study period, participants performed the same three tasks as before. RESULTS: Twenty-six participants were included, 13 in each group. At baseline, there were no differences between groups on all tested parameters. Compliance to training tasks was good. At the end of three weeks, subjects in both groups showed similar improvement of skills on the non-dominant side. On the dominant side, however, subjects in the training group showed significant better improvement of skills on four out of eight parameters. CONCLUSION: Specific training of the non-dominant upper extremity appears to lead to improvement of skills on the dominant side, a phenomenon known in literature as intermanual transfer of skill learning. To improve laparoscopic skills, bimanual training is recommended.

Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial).

BACKGROUND: Preterm prelabour rupture of the membranes (PPROM) is an important clinical problem and a dilemma for the gynaecologist. On the one hand, awaiting spontaneous labour increases the probability of infectious disease for both mother and child, whereas on the other hand induction of labour leads to preterm birth with an increase in neonatal morbidity (e.g., respiratory distress syndrome (RDS)) and a possible rise in the number of instrumental deliveries. METHODS/DESIGN: We aim to determine the effectiveness and cost-effectiveness of immediate delivery after PPROM in near term gestation compared to expectant management. Pregnant women with preterm prelabour rupture of the membranes at a gestational age from 34+0 weeks until 37+0 weeks will be included in a multicentre prospective randomised controlled trial. We will compare early delivery with expectant monitoring. The primary outcome of this study is neonatal sepsis. Secondary outcome measures are maternal morbidity (chorioamnionitis, puerperal sepsis) and neonatal disease, instrumental delivery rate, maternal quality of life, maternal preferences and costs. We anticipate that a reduction of neonatal infection from 7.5% to 2.5% after induction will outweigh an increase in RDS and additional costs due to admission of the child due to prematurity. Under these assumptions, we aim to randomly allocate 520 women to two groups of 260 women each. Analysis will be by intention to treat. Additionally a cost-effectiveness analysis will be performed to evaluate if the cost related to early delivery will outweigh those of expectant management. Long term outcomes will be evaluated using modelling. DISCUSSION: This trial will provide evidence as to whether induction of labour after preterm prelabour rupture of membranes is an effective and cost-effective strategy to reduce the risk of neonatal sepsis. CONTROLLED CLINICAL TRIAL REGISTER: ISRCTN29313500.

A comparison of the impact of screen-positive results obtained from ultrasound and biochemical screening for Down syndrome in the first trimester: a pilot study.

OBJECTIVE: To compare the experiences of women who received a screen-positive test result for Down syndrome after nuchal translucency screening or after biochemical screening in the first trimester of pregnancy in the Netherlands. METHOD: Semi-quantitative questionnaires were sent to 40 women with a screen-positive test result for Down syndrome in the first trimester of pregnancy: 20 had undergone nuchal translucency screening (NT group) and 20 had undergone serum screening (PAPP-A and free beta-hCG) (SS group). In all the cases, chorionic villus sampling (CVS) had not revealed any chromosomal abnormalities. RESULTS: The major reason for undergoing the screening test in both groups of women was to be more reassured about the health of the baby. In the NT group, 5 out of the 20 women stated that they had suddenly been confronted with the NT measurement during the ultrasound examination without even being asked, or had been caught by surprise about the possibility. Together with two other women, they felt that at that stage they had been insufficiently informed about what the test meant. In the SS group, two women also held this opinion. In 10 out of the 20 women in the SS group, the positive-screening result had caused (a great deal of) anxiety. In the NT group, this proportion was as high as 18 out of the 20. Six of the women in the NT group mentioned that 'seeing the baby' had been an important factor in their decision to undergo CVS. Even after a favourable result of CVS, a proportion of the pregnant women were still feeling anxious about the health of their baby (5 women in the SS group and 12 in the NT group). Nevertheless, a large proportion of the women in both groups was pleased that they had undergone the screening test. Only a few of them stated that they would not choose the same screening test again in a future pregnancy. CONCLUSIONS: An unfavourable screening result after NT screening appeared to have a greater impact than an unfavourable result after serum screening. This might partly be explained by the ultrasound examination visualising the increased risk during NT screening. An additional important role may have been played by the fact that an abnormal NT screening result implies an increased risk of other disorders besides Down syndrome, which the women should be informed about beforehand. Several factors place special demands on the counselling prior to NT screening.