A randomized prospective trial of the obstetric forceps versus the M-cup vacuum extractor. North Staffordshire/Wigan assisted delivery trial. A randomised prospective trial of the obstetric forceps versus vacuum extraction using defined criteria. Soft cup vacuum extraction: a comparison of outlet delivery. A prospective randomised controlled trial of the Kiwi Omnicup versus conventional ventouse cups for vacuum-assisted vaginal delivery. A randomized comparison of assisted vaginal delivery by obstetric forceps and polyethylene vacuum cup. A randomised controlled trial of a new handheld vacuum extraction device. A randomised prospective study comparing the new vacuum extractor policy with forceps delivery. [Comparative assessment of efficacy and safety of assisted vaginal delivery with forceps and with vacuum extractor]. Vacuum delivery at The Maternity Hospital Kuala Lumpur: a comparison of metal and silicone cups. A multicentre randomized trial comparing delivery with a silicone rubber cup and rigid metal vacuum extractor cups. A randomized study of two cups for vacuum extraction. Forceps or vacuum extraction? A comparison of effects on the newborn infant. A randomized comparison of vacuum extraction delivery with a rigid and a pliable cup. Soft forceps. A randomized prospective study comparing delivery with metal and silicone rubber vacuum extractor cups. Vacuum extraction: a randomized controlled comparison of the New Generation cup with the original Bird cup. Stepwise compared with rapid application of vacuum in ventouse extraction procedures. Comparison of vacuum extraction delivery between the conventional metal cup and the new soft rubber cup. Follow up of babies delivered in a randomized controlled comparison of vacuum extraction and forceps delivery. A randomised controlled trial of biopsy forceps and cannula aspiration for transcervical chorionic villus sampling. Obstetric forceps pad designed to reduce infant trauma. Rapid versus stepwise application of negative pressure in vacuum extraction-assisted vaginal delivery: a multicentre randomised controlled non-inferiority trial. The efficacy of facilitated tucking for relieving procedural pain of endotracheal suctioning in very low birthweight infants. Kiwi Omnicup versus Malmstrom metal cup in vacuum assisted delivery: a randomized comparative trial.
Our purpose was to determine the efficacy of the obstetric forceps versus the M-cup, a new vacuum extractor cup, and maternal-neonatal complication rates.
                Over a 10-month period operative vaginal deliveries were randomized between the obstetric forceps and the M-cup vacuum extractor cup. Maternal demographics, indication for intervention, analgesia, position, station, degree of asynclitism, fetal caput-molding, and time from application to delivery were prospectively recorded. Episiotomy and extensions, lacerations, and the reason for abandonment of the randomized instrument were noted in both groups. Fetal weight, Apgar scores, cord arterial gases, hyperbilirubinemia, phototherapy, and any evidence of fetal trauma were documented at delivery or in the nursery.
                Six hundred thirty-seven women were randomized, 315 in the forceps group and 322 in the M-cup group. There were no differences in maternal demographic variables. The station, position, degree of asynclitism, or requirement for rotation was not different between the groups. The corrected efficacy rates were forceps 92% and M-cup 94% (p = 0.217). The M-cup deliveries were accomplished more rapidly than forceps deliveries (p < 0.001) and were associated with a lower rate of episiotomy (p < 0.001), third-degree (p < 0.001) and fourth-degree (p = 0.002) lacerations, but blood loss as clinically estimated (p = 0.232) or as measured by hemoglobin levels (p = 0.166) was not significantly different. Forceps deliveries were associated with fewer clinically diagnosed cephalhematomas (p = 0.015) than M-cup deliveries were, but there were no differences in the number of neonates diagnosed with hyperbilirubinemia (p = 0.377) or in the number of infants treated with phototherapy (p = 0.660).
                The M-cup vacuum extractor cup appears to be as efficient (and faster) than the obstetric forceps but is associated with significantly more fetal cephalhematomas, whereas maternal injuries are more common with the forceps. In a trial conducted at the North Staffordshire and Billinge Maternity Hospitals (NSMH and BMH) a total of 264 women who required an assisted delivery in the second stage of labour were randomly assigned to be delivered either by Kobayashi silicone cup ventouse or by forceps. A larger proportion (90%) of those assigned to the forceps group were actually delivered by the allocated instrument compared to those in the silicone cup group (73%). However, there was a significantly higher rate of maternal morbidity in terms of perineal trauma and discomfort in the forceps group. No differences in neonatal morbidity were detected. The objective of this study was to determine the safety of obstetrics forceps when used under strictly defined criteria compared to vacuum extraction for delivery in the second stage of labour. A randomised prospective trial was performed on 442 women undergoing instrumental delivery in the second stage. Two hundred and four women were in the forceps group and 238 in the vacuum group. When using forceps traction efforts to deliver the baby were kept to less than three and the head was always delivered in the occipito-anterior position. In the two groups there were no significant difference in the incidence of third-degree perineal tears, post-partum haemorrhage or ruptured uterus. Cervical tears were slightly higher in the forceps group. Babies delivered by vacuum extraction showed a higher incidence of cephalhaematomas. There was no significant difference in babies needing resuscitation at birth, admission to neonatal intensive care unit, stillbirth or neonatal death rates. The failure rate was significantly higher in the vacuum group. The time taken to complete the procedure was significantly less in the forceps group. Forceps deliveries when performed under defined criteria are as safe as vacuum deliveries to the mother with a lesser failure rate and a lower incidence of cephalhaematomas in the neonate compared with vacuum deliveries. One hundred eighteen nulliparous patients delivered under conduction anesthesia who met the standard criteria for low forceps delivery were randomly assigned to one of three groups to be delivered by low Tucker-McLane forceps, Silastic vacuum extraction system, or Mityvac vacuum extractor. Significant maternal soft tissue trauma was identified in 48.9% of the forceps group, 36.1% of the Silastic group, and 21.6% of the Mityvac group. Superficial fetal scalp changes were found in 71% of the forceps group, 44% of the Silastic group, and 46% of the Mityvac group. Of these, cephalhematomatas were noted in 2.2% of the forceps group, 13.9% of the Silastic group, and 16.2% of the Mityvac group. All three instruments were considered effective outlet delivery instruments. To evaluate the performance and safety of the Kiwi Omnicup and compare it to conventional vacuum cups in routine clinical practice.
                A randomised controlled trial of the Kiwi Omnicup versus conventional vacuum cups.
                Queen Charlotte's and Chelsea Hospital, a tertiary referral hospital in London from April 2001 to March 2004.
                Women requiring assisted vaginal delivery by ventouse.
                Women were randomised to the Kiwi Omnicup (n=206) or conventional vacuum cups (n=198). Data regarding maternal demographics, labour, mode of delivery and maternal and neonatal outcome were collected.
                Failure of delivery with instrument of first choice.
                The Kiwi Omnicup was less successful at delivery with instrument of first choice than the conventional ventouse, failure rate 30.1 versus 19.2% (RR 1.58; 95% CI 1.10-2.24). It was associated with a greater number of cup detachments (mean 0.68 compared with 0.28, with 44% compared with 18% having at least one detachment [P<0.0001]). There was no difference in the incidence of severe maternal trauma, and there were no cases of serious neonatal injury.
                The Kiwi Omnicup is less successful than conventional ventouse in achieving vaginal delivery, but its safety profile is comparable. The assisted vaginal delivery methods of rigid obstetric forceps and polyethylene vacuum cup extraction were compared in a prospective, randomized study. The 99 women studied had all completed 35 full weeks' gestation, required attempted assisted vaginal delivery, and were randomly assigned to either attempted forceps or vacuum-assisted delivery. All presentations were cephalic, with stations ranging from +1 to +4. Neonates were evaluated at 24 hours by neonatal staff. The infants underwent intracranial ultrasound screening during the first 24 hours of life and ophthalmologic examination within 48 hours. Vaginal delivery was successful with the intended method in 83% of vacuum-assisted deliveries and in 78% of forceps deliveries (not statistically significant). Neonatal retinal hemorrhage was found in 17 and 38% (P less than .043) of the randomized forceps and vacuum deliveries, respectively. No intraventricular hemorrhage was found. Apart from associations between vacuum-assisted delivery and mild hyperbilirubinemia and neonatal retinal hemorrhage (of uncertain clinical significance), and between assisted forceps delivery and an increased potential for facial injury, neonatal outcomes did not differ significantly. Maternal outcomes also did not differ significantly. No significant differences in safety or efficacy were found between polyethylene cup vacuum extraction and rigid obstetric forceps-assisted vaginal delivery in this population of predominantly low-pelvic assisted deliveries. Patients delivered by sequential use of forceps after vacuum or by vacuum after failed forceps application did not suffer significantly increased morbidity relative to those delivered by forceps or vacuum alone. Use of alternate or sequential methods allowed an overall cesarean rate of 3% in this population. To evaluate the effectiveness of a new handheld vacuum delivery device.
                Randomised controlled trial.
                Southmead Hospital, Bristol, UK.
                One hundred and ninety-four women requiring delivery with vacuum extraction.
                Women were recruited into the study while still in early labour. If during delivery, vacuum extraction was indicated they were then randomly allocated to either a new handheld vacuum device, the Kiwi Omnicup, or to a 'standard' vacuum cup selected by the obstetrician. The 'standard group' consisted of the silastic (66/98, 67%) or the metal cups (32/98, 33%). Study data were recorded at completion of the delivery and at 24-48 hours. An additional brief symptom questionnaire was completed by the mother at 10 days postnatally. Statistical analyses were done on an 'intention-to-treat' basis.
                The primary outcome was the successful completion of delivery with the allocated instrument. Secondary outcomes were substantial fetal scalp trauma and substantial maternal trauma.
                The Omnicup was associated with a significantly higher failure rate than the standard cup [34%vs 21%, odds ratio (OR) = 1.9 (1.01-3.6)]. This difference persisted after adjusting for confounding factors [adjusted OR = 2.25 (1.01-5.0)] and resulted in significantly more forceps deliveries in the Kiwi Omnicup group [22%vs 10%, unadjusted OR = 2.5 (1.1-5.5)]. The caesarean section rates were similar in both groups [9.4%vs 8.2%, OR = 1.2 (0.4-3.2)]. Rates of substantial scalp trauma and maternal trauma were similar in both groups. However, there were more cases of jaundice in the standard cup group [2.3%vs 12.0%, unadjusted OR = 0.18 (0.04-0.82) and adjusted OR = 0.10 (0.01-0.88)].
                The Omnicup is not as successful at achieving a vaginal delivery as the combination of the currently used vacuum cups. To compare assisted vaginal delivery by forceps with delivery by vacuum extractor, where a new vacuum extractor policy was employed which dictated the cup to be used in specific situations.
                Multicentre randomised controlled trial.
                Four district general hospitals in the West Midlands.
                Six hundred-seven women requiring assisted vaginal delivery, of whom 296 were allocated to vacuum extractor delivery and 311 to forceps.
                Delivery success rate, maternal perineal and vaginal injuries, maternal anaesthetic requirements, neonatal scalp and facial injuries.
                Of the vacuum extractor group, 85% were delivered by the allocated instrument compared to 90% in the forceps group (odds ratio (OR) 0.64; 95% confidence intervals (CI) 0.4-1.04). However, more women in the vacuum extractor group were delivered vaginally (98%) than in the forceps group (96%). There were significantly fewer women with anal sphincter damage or upper vaginal extensions in the vacuum extractor group (11% vs 17%, OR 0.6; 95% CI, 0.38-0.97). There were significantly fewer women in the vacuum extractor group requiring epidural or spinal anaesthetics (25.4% vs 32.7%, OR 0.69; 95% CI 0.49-0.99) or general anaesthetics (1% vs 4%, OR 0.17; 95% CI 0.04-0.76). Although there were significantly more babies in the vacuum extractor group with cephalhaematomata (9% vs 3%, OR 3.3; 95% CI 1.4-7.4) there were fewer babies in the vacuum extractor group with other facial injuries. There were three babies in the forceps group with unexplained neonatal convulsions.
                Assisted vaginal delivery using the new vacuum extractor policy is associated with significantly less maternal trauma than with forceps. Further studies are required to assess neonatal morbidity adequately. We performed a prospective, controlled, randomized trial to compare de safety and efficacy between the vaginal assisted delivery with vacum extractor forceps. We included a control group of primigravidae. We use the ACOG application criteria for operative obstetrics. We measured the differences in regard to indication for operative delivery, obstetric trauma and the general characteristics of the patients. A total of 210 patients were included which were distributed in three groups. In the first group we included the patients of vacum extractor, the second group of forceps and the third the control group. In our results we found no statistically significant differences among three groups in regard to the general characteristics and obstetric trauma. In the vacum extractor group we found six cefalohematomas (8.5%), two newborns with skin laceration (2.8%) and four newborns with cerebral edema (5.7%). In the forceps group we had two newborns diagnosed with cefalohematomas (2.8%), seven newborns with cerebral edema (10%) and scalp laceration on four newborns (6%). In the control group we found one cefalohematoma (1.4%) and cerebral edema in four newborns (5.7%). We did not find statistically significant differences when we compared the group of the vacum and the forceps.
                With this information we concluded that both instruments are equal in regard to efficacy and safety when they are use by experimented hands and following the application criteria. Nevertheless, there is a high incidence of vaginal injuries and obstetric trauma in the newborn in the operative delivery compared with the control group without an important increase in the perinatal mortality. To compare the advantages and disadvantages of the New Bird metal cups and silicone cups in terms of maternal and foetal outcome. To study the adverse effects and factors associated with failed vacuum deliveries.
                A prospective randomised study of all vacuum deliveries from 1 December 1991 to 31 April 1992. The Hanshin electrical vacuum pump was used.
                A large obstetric unit-The Maternity Hospital Kuala Lumpur (MHKL).
                Seventy-two consecutive patients where vacuum deliveries were indicated. Forty had metal and 32 had silicone cups. Another 7 vacuum deliveries using the manual vacuum pump were excluded.
                Success rate of vaginal delivery, birth canal injuries, post-partum haemorrhage, duration of hospital stay, Apgar score, foetal injuries (scalp-ecchymosis, haematomas) neonatal jaundice, the rate of special care nursery (SCN) admission and neonatal mortality rate.
                Failure to deliver with silicone cups alone was 21.9% compared to 10% for metal cups alone. Material morbidities and serious foetal scalp injuries were almost the same in both cups. However, minor foetal scalp injuries were significantly lower with silicone cups. Maternal height and baby's weight had no independent predictive values for successful vacuum delivery. When the foetal head was palpable per abdomen, the failure rate was 54.5% compared to 8.2% when it was not. Failed vacuum deliveries were associated with increased maternal and foetal morbidities.
                Silicone cups and metal cups can be equally dangerous to the baby. Although our sample size was small, we recommend that vacuum delivery be avoided if the foetal head is palpable per abdomen. A total of 258 women requiring assisted delivery where vacuum extraction was thought to be suitable were randomly allocated to delivery with a new silicone rubber cup or metal vacuum extractor cups. There was a tendency for the silicone rubber cup to effect delivery more quickly and to cause less scalp trauma, but to fail to effect delivery on more occasions than metal cups. However, none of these differences was statistically significant. There were no statistically significant differences in the rates of birth canal trauma, maternal blood loss, or neonatal jaundice. The silicone rubber cup produced a cosmetically more acceptable chignon than the metal cups. The introduction of vacuum extractors with silicone rubber cups into obstetric units should be encouraged. O'Neil designed a set of suction cups which, because of more efficient lateral pull and greater maneuverability, were claimed to be more efficient and perinatally safer than the Malmström model. These claims were checked by comparing the two instruments in a randomized controlled trial comprising 410 attempted elective extractions. The two instrument groups were comparable at entry and the operators had a similar degree of experience, the sole inter-group difference being the 0.5 cm larger diameter of the O'Neil cups. No significant differences were found between the two types of instrument as to failure rate, incidence of correct cup positioning, and capacity of eliciting internal rotation nor was there a significant divergence in neonatal safety. In a few cases the perineum was lacerated by the traction cord affixed to the O'Neil instrument. The results of this study indicate that the relative advantages and disadvantages of the two cup models are unremarkable. Sixteen women delivered by forceps and 20 women delivered by vacuum extraction (VE) owing to secondary uterine inertia were compared with a control group of 11 women who gave birth spontaneously. The cord arterial pH was lower in the VE group than in the forceps and control groups. Base deficit in both arterial and venous cord blood was greater in the VE group than in the forceps group, probably owing to the longer application and extraction times in VE than in forceps delivery. The incidence of retinal hemorrhage did not differ between the forceps and VE groups. The incidence of cephalhematomata was greater among VE infants than in the forceps and control groups. All infants were examined on the 1st and 5th day by standardized neurological and behavioural examination. There were no significant differences in neurological status between the forceps and VE groups. Thus, in low extraction with no signs of fetal asphyxia, either method can be used with safety if the obstetrician is familiar with both methods of operative vaginal delivery. To compare the effectiveness and complications of obstetric vacuum extraction with a rigid and a pliable cup, with a focus on neonatal retinal hemorrhage.
                One hundred women requiring assisted delivery who met predefined criteria for vacuum extraction were randomly assigned to be delivered by the classic rigid Malmström cup or the pliable Silastic cup.
                Because of the faster induction of vacuum, delivery occurred more rapidly with the pliable cup, but the pliable cup detached significantly more often than the rigid cup. The overall failure rate was not significantly different between the cups. There were no significant differences between the groups with regard to Apgar scores, umbilical artery pH, birth canal trauma, or maternal blood loss, but scalp injury occurred less frequently with the soft than with the rigid cup. Retinal hemorrhage in the newborns showed a similar incidence of about 50%, and neonatal neurologic examination showed no significant differences between the groups.
                In comparison with the rigid cup, the advantage of the pliable cup is limited to a smaller incidence of neonatal scalp injury. The risk of maternal and fetal trauma and, chiefly, the fear of law suits, have contributed to a significant decline in rates of forceps-assisted deliveries and an increase in rates of cesarean sections, especially in the United States. Our experience with gas-sterilized forceps blades covered with a soft rubber coating--the "soft" forceps--is described.
                Ninety-six women who required a forceps-assisted delivery for standard indications were randomly allocated to 2 groups. There were 51 women in the regular forceps group and 45 women in the soft forceps group. Low forceps delivery with a Simpson instrument was used in all cases. The groups were compared for fetal injury.
                The rates of severe facial abrasion and minimal marking were 4.1% and 61%, respectively, in the regular forceps group and 1.9% and 34% in the soft forceps group.
                The soft forceps may reduce the rates of neonatal facial abrasion and skin bruises. The forceps should be further perfected, as well as vacuum extractors; they should both continue to be part of the obstetrician's armamentarium. To determine the relative benefits and complications of assisted vaginal delivery with metal and silicone rubber vacuum extractor cups.
                Prospective randomized controlled study.
                A busy referral maternity hospital in Kathmandu, Nepal.
                101 women were assigned to delivery with the Silc-cup and 98 to delivery with the metal cup.
                Success rate at achieving delivery with the assigned instrument and incidence of neonatal trauma. Analysis was by 'intention to deliver' with women remaining in their original group regardless of the eventual mode of delivery.
                Randomization resulted in two groups of women similar in respect of age, parity, gestation and indication for delivery. The overall success rate was similar for the two instruments (Silc-cup 85% and metal cup 87%). The Silc-cup was more likely to fail if there was excessive caput (seven failures compared with one in the metal cup group). The frequency of clinically significant maternal trauma was low in both groups. There were fewer babies with clinically significant scalp trauma in the Silc-cup group (22%), compared with the metal cup group (37%).
                The data indicate a greater tendency for the Silc-cup to fail when excessive caput is present but that metal cups are associated with increased scalp injuries. A new design of vacuum extractor cup--'the New Generation cup'--has recently been introduced into clinical practice. Its major modification is a traction cord which passes around the rim of the cup for 180 degrees and is free to slide within the rim. Claims that this design 'enables the operator to pull obliquely without causing the cup to tilt' and thereby 'reduces failure rates, reduces the incidence of scalp trauma and increases operator confidence' have been evaluated in a randomized controlled trial. 123 women with singleton pregnancies of 37 completed weeks or more, with a cephalic presentation and for whom a decision to deliver by vacuum extraction had been taken, were randomly allocated to the 'New Generation' cup or BIRD's original vacuum extractor cup; 50 mm anterior and posterior cups were used in both groups as appropriate. The two groups were comparable at entry and delivered by obstetricians of similar status. The two types of cup were similar in respect of number of failures to deliver with the vacuum extractor, correct positioning of the cup, number of pulls required for delivery and time taken to expedite delivery. Cup detachments occurred in nine cases allocated to the 'New Generation' cup compared with four allocated to the original BIRD cup. The babies in the two groups were in similar condition at birth and sustained similar amounts of scalp trauma. Neonatal jaundice, both clinical and biochemical, was more common in babies delivered with the 'New Generation cup' and this was reflected in greater use of phototherapy in this group. Operators were equally divided in their preference of cup.(ABSTRACT TRUNCATED AT 250 WORDS) To compare a one-step (rapid) application of negative pressure (vacuum) with conventional stepwise application for ventouse extraction following a prolonged second stage of labour.
                Randomised controlled study.
                Teaching Hospital.
                Forty-seven women were randomised to the rapid vacuum group and 47 to the stepwise group.
                Duration of ventouse procedure, effectiveness of methods of application, morbidity of mother and infant.
                There was no significant difference in frequency of detachment of the cup after rapid or stepwise application of vacuum. A reduction in mean duration of the ventouse procedure of 6 min was realised without significant difference in maternal or neonatal morbidity.
                Rapid application of vacuum significantly reduces the duration of a ventouse extraction procedure without compromise to efficiency and safety. To compare the effectiveness and complications of vacuum extraction delivery between the conventional metal cup and the silicone rubber cup. A prospective randomized clinical trial of 90 pregnant women requiring assisted vaginal delivery who met the predetermined criteria for vacuum extraction were allocated to delivery by the Malstrom metal cup (46 cases) or the silicone rubber cup (44 cases). The two groups were similar in respect of age, parity gestational age and indications for assisted vaginal delivery. The mean and median numbers of tractions and time from cup application to delivery were not significantly different between the groups. The overall success rate was higher in the metal cup (89.1%) than in the rubber cup (79.5%) but not significantly different. The silicone cup was more likely to fail in cases of occiput posterior position, excessive caput, and severe degree of molding. There were no significant differences between groups in terms of Apgar scores, birth canal injury, and maternal blood loss. Scalp injuries occurred more frequently with the metal than with the rubber cup (P = 0.006). Vacuum extraction delivery with the silicone rubber cup is associated with reduced scalp injuries but has a greater tendency to fail when the fetus presents in occiput posterior position, has excessive caput or severe degree of molding. Babies delivered in a randomized controlled comparison of vacuum extraction vs. forceps delivery were reassessed at 9 months of age. There were no statistically significant differences between the two groups as regards head circumference, weight, or head circumference to weight ratio, nor in the results of hearing and vision tests. The reasons for hospital readmission, pediatric follow-up and parents' and health visitors' worries appeared to be unrelated to the mode of delivery in nearly all cases. The finding in the original trial that neonatal jaundice was more common following vacuum extraction was reinforced by an additional case of jaundice in the vacuum extractor group which had necessitated readmission to hospital. This trial compared two instruments for transcervical chorionic villus sampling (CVS).
                Randomised controlled trial.
                Regional university prenatal diagnosis and treatment centre.
                Two hundred women were randomised at 10(+0)-12(+6) weeks of gestation to transcervical CVS using cannula aspiration (CA) or biopsy forceps (BF).
                Women undergoing indicated CVS signed informed consent. Randomisation after decision to perform transcervical CVS.
                Primary outcome: the rise in maternal serum alpha-fetoprotein (alpha-FP). Secondary outcomes: (i) placental trauma (fetomaternal haemorrhage [FMH]); (ii) laboratory, procedure, and cytogenetic results and pregnancy outcomes; (iii) patient and operator satisfaction; and (iv) economic analyses. Analyses were performed by intention to treat.
                The -FP rise did not differ between groups; there was no other evidence of placental trauma. BF were better tolerated by women, provided culturable tissue, after fewer instrument passes, with greater ease and in less time. BF were associated with cost savings.
                Unlike -FP, other markers of FMH were unaltered, questioning the reliability of alpha-FP as an indicator of FMH. Compared with CA, transcervical BF caused comparable placental trauma, appeared to be similarly effective and safe and were preferred by operators and patients. The use of the standard obstetric forceps has been associated with varying degrees of maternal and fetal trauma. To reduce the degree of skin markings, a pliable polyurethane pad with selfadherent backing has been designed, which can be applied to each blade of the forceps. One hundred five neonates who required forceps-assisted deliveries were observed for evidence of skin trauma immediately after delivery and again at 24 hours. Padded forceps significantly reduced craniofacial visible skin markings when compared with the skin markings produced by the unpadded forceps. The addition of the pad to the forceps blade had no adverse effect on the mother, and obstetricians encountered no problems in the application and use of the pads. To evaluate whether the application of rapid negative pressure for vacuum-assisted delivery is as effective and safe as the stepwise method.
                Randomised controlled trial.
                Six centres, including university, secondary and tertiary hospitals, in Thailand.
                In total, 662 women were randomised to rapid and stepwise groups, with 331 women in each group.
                Vacuum extraction was performed by applying a metal cup (Malmstrom) connected to an electric pump to the fetal head. The stepwise method consisted of four incremental steps of 0.2 kg/cm² every 2 minutes to obtain a final negative pressure of 0.8 kg/cm². In the rapid method the negative pressure of 0.8 kg/cm² was applied in one step in < 2 minutes.
                Success rate of vacuum extraction, vacuum cup detachment rate, duration of vacuum extraction, and maternal and neonatal complications.
                There were no significant differences in detachment rates (RD 0.3%, 95% CI -3.1 to 2.4). The overall success rates were identical, at 98.2%. There were significant reductions in the time between applying the vacuum cup and attaining maximum negative pressure (MD -4.6 minutes; 95% CI -4.4 to -4.8 minutes), and in the time between applying the cup and delivery (MD -4.4 minutes; 95% CI -4.8 to -4.0 minutes). There was a significantly higher rate of perineal suture in the rapid method group (RD 4.5%; 95% CI 1.1-8.2). There were no significant differences in maternal and fetal morbidities.
                Rapid negative pressure vacuum extraction could be performed as effectively and safely as the stepwise method, in a shorter period of time.
                © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG. This study compared the efficacy of a behavioral pain reducing intervention (facilitated tucking) with standard neonatal intensive care unit (NICU) care for decreasing procedural pain (endotracheal suctioning) in very low birthweight (VLBW) infants.
                A prospective randomized crossover design with infants as their own controls were used. The sample consisted of 40 VLBW infants, 23-32 weeks gestation, and weighing 560-1498 g with tracheal intubation. The infants were observed twice during each endotracheal suctioning experience; one suctioning was done according to normal nursery routine; another was done using facilitated tucking (the caregiver "hand-swaddling" the infant by placing a hand on the infant's head and feet while providing flexion and containment). The Premature Infant Pain Profile (PIPP) measured the infant's pain response, and severity of illness of each infant was measured by the Score for Neonatal Acute Physiology (SNAP) and the NTISS (Neonatal Therapeutic Intervention Scoring System). Repeated measures analysis of variance (RMANOVA) determined the efficacy of facilitated tucking for reducing procedural pain (PIPP) and the effects of order of intervention vs. control. Regression analyses examined the relationship of gestational age, severity of illness, and number of painful procedures to the pain response.
                There was a significant difference between the PIPP scores for tucking and nontucking positions (p = 0.001) and a nonsignificant interaction with order (p = 0.64) as well as a nonsignificant main effect for order (p = 0.46). In the regression analyses, all predictors taken together did not significantly predict PIPP scores in the tucked position (p = 0.11) or nontucked position (p = 0.57).
                Facilitated tucking is a developmentally sensitive, nonpharmacological comfort measure that can relieve procedural pain in VLBW infants. Nurses need to be increasingly aware of infant pain during daily care taking, and to use validated pain assessment instruments. Further clinical research on individual pain assessment is needed for better understanding of the quality and significance of pain for each infant, and the factors that affect pain expression. To compare the success, clinical outcomes, and maternal and neonatal complications between the Kiwi Omnicup and the Malmstrom metal cup in vacuum assisted delivery.
                This was a prospective randomized comparative trial. Women who required vacuum assisted vaginal delivery were randomized into the Kiwi Omnicup (KO) group and the Malmstrom metal cup (MM) group. The vacuum assisted deliveries were conducted according to hospital protocol. Details of the procedure and delivery outcomes including success and complications were analyzed.
                One hundred and sixty-four women were recruited - 85 were assigned to vacuum assisted delivery using the KO and 79 the MM. One hundred percent delivery success was achieved with no significant differences between the two instruments in terms of maternal morbidity (P = 0.66). Six women in the MM group sustained post delivery complications in comparison to five in the KO group. Three babies were diagnosed with birth asphyxia in each group. More babies in the MM group were admitted to the Neonatal Intensive Care Unit (NICU) (10 babies versus 5 babies) and suffered complications (14 versus 12 babies), compared to the KO group, although the difference was not statistically significant. There were no intrapartum or neonatal deaths and of those admitted to the NICU, all were discharged within a week without any serious consequences.
                Kiwi Omnicup is an effective alternative to the currently available Malmstrom metal cup for vacuum assisted delivery with no increase in maternal or neonatal morbidity or mortality.
There is a recognised place for forceps and all types of ventouse in clinical practice. The role of operator training with any choice of instrument must be emphasised. The increasing risks of failed delivery with the chosen instrument from forceps to metal cup to hand-held to soft cup vacuum, and trade-offs between risks of maternal and neonatal trauma identified in this review need to be considered when choosing an instrument.