A randomized controlled trial of prophylactic maneuvers to reduce head-to-body delivery time in patients at risk for shoulder dystocia. Randomized trial of McRoberts versus lithotomy positioning to decrease the force that is applied to the fetus during delivery. Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage. Use of surfactant for prophylaxis versus rescue treatment of respiratory distress syndrome: experience from an Italian-Bulgarian trial. Randomised controlled trial of effect of hands and knees posturing on incidence of occiput posterior position at birth. The effect of unrestricted oral carbohydrate intake on labor progress. The use of thromboembolic deterrent stockings and a sequential compression device to prevent spinal hypotension during caesarean section. Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial. Clinical implications from an exploratory study of postural management of breech presentation.
To assess whether prophylactic use of the McRoberts maneuver and suprapubic pressure decreased the head-to-body time, as a proxy for shoulder dystocia, in at-risk patients.
                Patients with estimated fetal weights over 3800 g were randomized to undergo the McRoberts maneuver and suprapubic pressure before delivery of the fetal head (prophylactic maneuvers) or to undergo maneuvers only after delivery of the head, if necessary (controls). A total of 185 patients were enrolled in the study. After exclusions (eg, abdominal delivery), there were 128 evaluable vaginal deliveries. The study had the power to detect a 30% difference in head-to-body time between groups.
                Head-to-body delivery times did not differ between the prophylactic and control patients (24 +/- 18 seconds versus 27 +/- 20 seconds, P =.38). In addition, the two groups did not differ in rates of admission of the infant to the special care nursery or in birth injuries. There was a significant increase in the risk of delivering by cesarean for patients randomized to the use of prophylactic maneuvers.
                This study does not support the hypothesis that prophylactic use of the McRoberts maneuver and suprapubic pressure speeds delivery in a population of patients at increased risk for shoulder dystocia. In an effort to reduce shoulder dystocia incidence and morbidity, some obstetricians use prophylactic maternal hip hyperflexion (McRoberts maneuver), with the hope of facilitating delivery and decreasing the traction needed for delivery. The objective of this study was to evaluate whether the delivery force is reduced with the prophylactic McRoberts maneuver in a prospective, objective manner.
                Between April 2002 and July 2003, we randomly assigned multiparous women with term, cephalic singleton gestations to delivery in the lithotomy or McRoberts position. A single physician used a force-measuring system that consisted of a custom glove with force sensors to record the amount of force that was exerted on the fetal head. The primary outcomes of the study were peak force (pounds; highest force needed to accomplish entire delivery), peak force for delivery of anterior shoulder (pounds), and peak force rate (pounds per second; the duration required to reach the peak force).
                The peak force was not different between the patients in the lithotomy position (n=13) versus the McRoberts position (n=14; 7.2 +/- 0.8 lbs vs 8.0 +/- 0.7 lbs; P = .5). The peak force for delivery of the anterior shoulder (6.7 +/- 0.8 lbs vs 7.1 +/- 0.7 lbs; P = .7) and peak force rate (32.3 +/- 7.0 lbs/sec vs 29.1 +/- 3.5 lbs/sec; P = .7) were not different between the patients in the lithotomy position versus the McRoberts position, respectively. There was no difference between the groups for gestational age, birth weight, incidence of diabetes mellitus, or operative vaginal delivery. The subjective degree of difficulty of the delivery correlated with the peak force (R2 = 0.53; P = .001).
                The use of the McRoberts maneuver before clinical diagnosis of shoulder dystocia provides no reduction in the force that is used in traction on the fetal head during vaginal delivery in multiparous patients. The acceptance of this maneuver to be used prophylactically requires re-evaluation. To compare by randomized prospective clinical trial the outcome of labours which are managed with the intention to leave the membranes intact, compared with the practice of elective artificial rupture of the membranes (ARM) in early established labour.
                Prospective randomized controlled trial of low risk women admitted in spontaneous labour, with intact membranes.
                The labour ward of St. James's University Hospital, Leeds, UK.
                362 women in spontaneous labour with intact membranes and no evidence of fetal distress, between 37 and 42 weeks gestation. During the course of the trial it was found that some randomization cards could not be accounted for and a system of daily checks was instituted. The results were analysed for all recorded women (n = 362) and after institution of the more rigorous system (n = 120).
                The duration of each phase of labour, epidural rate, prevalence of an abnormal cardiotocograph (CTG) (assessed blind), method of delivery and neonatal outcome.
                178 of the 183 women (97%) in the ARM group had their membranes ruptured in early labour, and 83 (46%) of the 179 women allocated to non-intervention had ARM performed at some stage. A significant decrease in the duration of labour (mean 8.3, SD 4.1 h vs mean 9.7, SD 4.8 h, n = 156; P = 0.05) was found amongst primigravidae allocated to ARM when compared with non intervention. The duration of the second stage of labour was unaffected. In the ARM group the epidural rate was higher and labour was more often complicated by CTG abnormalities. There were no differences in the method of delivery, fetal condition at birth (cord blood lactate, Apgar score) or postpartum pyrexia between the ARM and non-intervention groups. The same trends were observed when analysis was confined to women entered into the trial after the system of rigour was instituted.
                Routine ARM results in labour that is slightly shorter than if the membranes are allowed to rupture spontaneously but more epidurals are used suggesting that labour is more painful. There are fewer fetal heart rate abnormalities if the membranes are left intact but amniotomy has no effect on fetal condition at birth. To show if surfactant applied in different social-sanitary realities as prophylaxis of respiratory distress syndrome (RDS) is equally useful and able to reduce mortality and incidence of 3-4 radiological grade RDS.
                Two neonatal intensive care units (NICU) in Italy, one NICU in Bulgaria and one NICU in Romania were involved in a randomized controlled clinical trial of prophylaxis vs rescue treatment of RDS. Babies with gestational age 26-30 wks were randomized before birth to prophylaxis in the delivery-room with 200 mg/kg of porcine surfactant (prophylaxis) or to routine assistance (control). Subsequently the babies developing RDS requiring mechanical ventilation and fraction of inspired oxygen (FiO2) > or = 0.4 to maintain PaO2 about 50 mmHg were allowed to be treated rescue with 200 mg/kg of the same surfactant. To reach end-points of reducing mortality by 40% and incidence of radiological grade 3-4 RDS a total number of 174 patients were required.
                Due to logistic, practical and social-political problems the study was interrupted after enrollment of 93 babies (61 in Italy and 32 in Bulgaria). The Romanian centre did not start the study because it was impossible in the scheduled times to equip it for mechanical ventilation of the newborn infants. Analysis done on an intention to treat basis did not show significant reductions of mortality and 3-4 radiological grade RDS, even if there was a trend towards a reduction in the babies given prophylaxis. A significantly lower number of babies given prophylaxis required a subsequent rescue treatment compared to controls (p < 0.001). There was no difference in other complications such as intraventricular haemorrhage, air-leak syndromes and infections between prophylaxis and control infants. As regards pulmonary gas exchange, the PaO2/FiO2 ratio was significantly improved in the babies given prophylaxis for the first 12 hours of life vs the controls.
                Even if the study was terminated before term, the analysis of the data shows that prophylaxis with surfactant is equally effective in different social-clinical conditions to improve pulmonary gas-exchange, especially in the first critical hours of life of premature babies. To evaluate the efficacy of hands and knees position and pelvic rocking exercises on the incidence of fetal occiput posterior position at birth.
                Multicentre randomised controlled trial.
                Seven maternity units in New South Wales, Australia, encompassing teaching hospitals and district general hospitals.
                2547 pregnant women at 37 weeks' gestation; 1292 randomised to the intervention group and 1255 to the control group.
                Hands and knees position and pelvic rocking exercises from 37 weeks' gestation until the onset of labour.
                Incidence of fetal occiput posterior position at birth.
                1046 women in the intervention group and 1209 women in the control group remained in the study until they went into labour. No significant difference existed between the groups for the incidence of occiput posterior position at birth: 105 (8.1%) women in the intervention group and 98 (7.8%) in the control group had a baby in a posterior position at delivery (difference in risk 0.3%, 95% confidence interval -1.8 to 2.4). The incidence of fetal transverse arrest was 3.4% (44 women) in the intervention group and 3.0% (38 women) in the control group (difference in risk 0.4, -1 to 1.7). No differences occurred between intervention and control groups for induction of labour, use of epidural, duration of labour, mode of delivery, use of episiotomy, or Apgar score.
                Hands and knees exercise with pelvic rocking from 37 weeks' gestation to the onset of labour did not reduce the incidence of persistent occiput posterior position at birth. To determine if unrestricted oral carbohydrate intake during labor reduced the incidence of dystocia in low-risk nulliparous women.
                A randomized clinical trial at a university-affiliated hospital in southeastern Ontario. Low-risk nulliparous women were randomized between 30 and 40 weeks gestation to either an intervention or usual care group.
                Women in the intervention group received, prenatally, guidelines about food and fluid intake during labor and were encouraged to eat and drink as they pleased during labor. Women in the usual care group received no prelabor information and were restricted to ice chips and water during labor in the hospital.
                The incidence of dystocia, defined as a cervical dilatation rate of less than 0.5 cm/hr for a period of 4 hrs after a cervical dilatation of 3 cm.
                Three hundred twenty-eight women were randomized to the intervention (n = 163) or usual care (n = 165) groups. Women in the intervention group reported a significantly different pattern of oral intake during early labor in the hospital (chi(2) = 40.7, p < .001). The incidence of dystocia was 36% (n = 58) in the intervention group and 44% (n = 72) in the usual care group and was not significantly different (OR = 0.71, 95% CI = 0.46, 1.11). There were no significant differences in the other secondary outcomes or in the incidence of adverse maternal or neonatal complications.
                Eating and drinking early in labor had no significant impact on the incidence of dystocia and/or adverse maternal or neonatal outcomes. Hypotension is a common side effect of spinal anaesthesia for caesarean section. We have performed a randomised, controlled study to determine the efficacy of a sequential compression device (SCD) (Kendall) in combination with thromboembolic deterrent (TED) stockings (Kendall) to reduce the incidence of hypotension in this setting. Within 20 min of spinal injection, there was no statistically significant difference in the incidence of hypotension (defined as less than 100 mmHg and less than 80% of baseline blood pressure) (TED/SCD group 65%, control 80%, P = 0.12). However, there was a trend for those receiving TED/SCD prophylaxis to require less ephedrine to maintain normotension than the control group (median TED/SCD 3 mg, control 6 mg, P = 0.08). The administration of ephedrine deviated from protocol on a total of 46 occasions (2.3% of recordings). To try to reduce the influence of this, we reinspected our data using time to first episode of hypotension with a Kaplan-Meier survival analysis. This showed that the instantaneous risk (hazard) of developing hypotension was 1.8 (95% CI: 1.1-2.9) times higher in controls than those receiving TED/SCD prophylaxis (P = 0.02). Despite demonstrating some benefit of TED/SCD prophylaxis to prevent hypotension, we do not consider that the magnitude of this benefit warrants their routine use. This study tested the hypotheses that active management of the third stage of labour lowers the rates of primary postpartum haemorrhage (PPH) and longer-term consequences compared with expectant management, in a setting where both managements are commonly practised, and that this effect is not mediated by maternal posture.
                1512 women judged to be at low risk of PPH (blood loss >500 mL) were randomly assigned active management of the third stage (prophylactic oxytocic within 2 min of baby's birth, immediate cutting and clamping of the cord, delivery of placenta by controlled cord traction or maternal effort) or expectant management (no prophylactic oxytocic, no cord clamping until pulsation ceased, delivery of placenta by maternal effort). Women were also randomly assigned upright or supine posture. Analyses were by intention to treat.
                The rate of PPH was significantly lower with active than with expectant management (51 [6.8%] of 748 vs 126 [16.5%] of 764; relative risk 2.42 [95% CI 1.78-3.30], p<0.0001). Posture had no effect on this risk (upright 92 [12%] of 755 vs supine 85 [11%] of 757). Objective measures of blood loss confirmed the results. There was more vomiting in the active group but no other important differences were detected.
                Active management of the third stage reduces the risk of PPH, whatever the woman's posture, even when midwives are familiar with both approaches. We recommend that clinical guidelines in hospital settings advocate active management (with oxytocin alone). However, decisions about individual care should take into account the weights placed by pregnant women and their caregivers on blood loss compared with an intervention-free third stage. The results from an exploratory study of the effectiveness of maternal knee-chest posture for producing cephalic version of breech presentation are shown. Methods are briefly described and clinical implications are presented. Among 25 women, fewer who performed the maternal knee-chest postural intervention experienced fetal cephalic version than women in the control group who did nothing to influence breech presentation. Despite limitations of the underpowered findings, trends in the data may indicate that parity and gestational age were potentially relevant covariates of version. Postural management is not an evidence-based practice. This exploratory study indicates that maternal knee-chest posture may work opposite to the expected direction, but the small sample size precludes generalizations about efficacy of knee-chest postural management. At least one adequately powered trial that controls for parity and gestational age is needed to determine whether knee-chest postural management results in no effect, a small, or small to moderate clinically significant effect.
There are no clear findings to support or refute the use of prophylactic manoeuvres to prevent shoulder dystocia, although one study showed an increased rate of caesareans in the prophylactic group. Both included studies failed to address important maternal outcomes such as maternal injury, psychological outcomes and satisfaction with birth. Due to the low incidence of shoulder dystocia, trials with larger sample sizes investigating the use of such manoeuvres are required.