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An infant with congenital diaphragmatic hernia was delivered by vacuum extraction, with a resultant subgaleal hemorrhage that excluded him from ECMO. The literature regarding vacuum-assisted delivery and birth trauma is reviewed in the context of congenital anomalies that may require ECMO support, and recommendations for perinatal management are suggested.
BACKGROUND: The original cups used for vacuum extraction delivery of the fetus were rigid metal cups. Subsequently, soft cups of flexible materials such as silicone rubber or plastic were introduced. Soft cups are thought to have a poorer success rate than metal cups. However they are also thought to be less likely to be associated with scalp trauma and less likely to injure the mother. OBJECTIVES: The objective of this review was to assess the effects of soft versus rigid vacuum extractor cups on perineal injury, fetal scalp injury and success rate. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. Date of last search: February 2000. SELECTION CRITERIA: Acceptably controlled comparisons of soft versus rigid vacuum extractor cups. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: Nine trials involving 1375 women were included. The trials were of average quality. Soft cups are significantly more likely to fail to achieve vaginal delivery (odds ratio 1.65, 95% confidence interval 1.19 to 2.29). However, they were associated with less scalp injury (odds ratio 0.45, 95% confidence interval 0.15 to 0.60). There was no difference between the two groups in terms of maternal injury. REVIEWER'S CONCLUSIONS: Metal cups appear to be more suitable for 'occipito-posterior', transverse and difficult 'occipito-anterior' position deliveries. The soft cups seem to be appropriate for straightforward deliveries.
BACKGROUND: Induced abortions are very commonly practiced interventions worldwide. A variety of medical abortion methods have been introduced during the last decade in addition to existing surgical methods. In this review we systematically searched for and combined all evidence from randomised controlled trials comparing surgical with medical abortion. OBJECTIVES: To evaluate medical methods in comparison to surgical methods for first-trimester abortion with respect to efficacy, side effects and acceptability. SEARCH STRATEGY: The Cochrane Controlled Trials Register, MEDLINE (with the Cochrane 3-stage search strategy)(1966-2000) and Popline (1970-2000) were systematically searched. There were no language preferences in searching. Reference lists of retrieved papers were searched. Experts in WHO/HRP were contacted. SELECTION CRITERIA: Randomised trials of any surgical abortion method compared with any medical abortion method in the first trimester. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data extraction was made independently by two reviewers. MAIN RESULTS: Five studies mostly with small sample sizes, comparing 4 different interventions (prostaglandins alone, mifepristone alone, and mifepristone/misoprostol and methotrexate/misoprostol versus vacuum aspiration) were included. Results are sometimes based on one trial only. Prostaglandins vs vacuum aspiration: the rate of abortions not completed with the intended method was statistically significant higher in the prostaglandin group (2.7, 95% CI 1.1 to 6.8) compared to surgery. There are no data on the most commonly medical (mifepristone/misoprostol) and surgical abortion available to be included in the review. Duration of bleeding was longer in the medical abortion groups compared to vacuum aspiration. There was only one major complication (uterine perforation) in one trial in the surgical group. There was no difference between the groups for ongoing pregnancies at the time of follow-up or pelvic infections. No data on acceptability, side effects or women's satisfaction with the procedure were available for inclusion in the review. REVIEWER'S CONCLUSIONS: The results are derived from small trials. Prostaglandins used alone seems to be less effective and more painful compared to surgical first-trimester abortion. However, there is inadequate evidence to comment on the acceptability and side effects of medical compared to surgical first-trimester abortions. There is a need for trials to address the efficacy of currently used methods and women's preferences more reliably.
BACKGROUND: Induced abortions are very commonly practiced interventions worldwide. A variety of medical abortion methods have been introduced during the last decade in addition to existing surgical methods. In this review we systematically searched for and combined all evidence from randomised controlled trials comparing surgical with medical abortion. OBJECTIVES: To evaluate medical methods in comparison to surgical methods for first-trimester abortion with respect to efficacy, side effects and acceptability. SEARCH STRATEGY: The Cochrane Controlled Trials Register, MEDLINE (with the Cochrane 3-stage search strategy)(1966-2000) and Popline (1970-2000) were systematically searched. There were no language preferences in searching. Reference lists of retrieved papers were searched. Experts in WHO/HRP were contacted. SELECTION CRITERIA: Randomised trials of any surgical abortion method compared with any medical abortion method in the first trimester. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data extraction was made independently by two reviewers. MAIN RESULTS: Six studies mostly with small sample sizes, comparing 4 different interventions (prostaglandins alone, mifepristone alone, and mifepristone/misoprostol and methotrexate/misoprostol versus vacuum aspiration) were included. Results are sometimes based on one trial only. Prostaglandins vs vacuum aspiration: the rate of abortions not completed with the intended method was statistically significant higher in the prostaglandin group (2.7, 95% CI 1.1 to 6.8) compared to surgery. There are no data on the most commonly medical (mifepristone/misoprostol) and surgical abortion available to be included in the review. Duration of bleeding was longer in the medical abortion groups compared to vacuum aspiration. There was only one major complication (uterine perforation) in one trial in the surgical group. There was no difference between the groups for ongoing pregnancies at the time of follow-up or pelvic infections. No data on acceptability, side effects or women's satisfaction with the procedure were available for inclusion in the review. AUTHORS' CONCLUSIONS: The results are derived from relatively small trials. Prostaglandins used alone seems to be less effective and more painful compared to surgical first-trimester abortion. However, there is inadequate evidence to comment on the acceptability and side effects of medical compared to surgical first-trimester abortions. There is a need for trials to address the efficacy of currently used methods and women's preferences more reliably.
OBJECTIVE: In May 1998 the US Food and Drug Administration (FDA) issued a health advisory reporting neonatal injuries/deaths following vacuum delivery and encouraged voluntary reports of future adverse events. We compared FDA reports of vacuum delivery adverse events prior to and following the advisory. METHODS: The FDA database (MAUDE) was searched for vacuum deliveries using brand name, manufacturer name, and procedure "string searches." Cases were sorted by report date, source, and manufacturer. Neonatal morbidity was quantified as deaths and life-threatening or nonlife-threatening events. RESULTS: A total of 80 reported adverse cases were identified after duplicate cases were consolidated. Twenty-five were reported to the FDA prior to the 1998 advisory and 55 in the immediate 6-month period following the advisory. There was a 22-fold increase in reported events from five events/year prior to the advisory to an estimated 110 events/year following the advisory. The distribution of reporting sources changed significantly following the advisory with increased "manufacturer" (8-43%) and decreased "voluntary" reports (56-20%). All major brand names were represented. During the 6 months following the FDA advisory there were 10 neonatal deaths, 30 life-threatening events, 12 nonlife-threatening events, and three equipment-related reports. Infant deaths were due to intracranial or subgaleal hematomas. Injuries included skull fracture, scalp abrasions, and cephalohematomas. CONCLUSIONS: The FDA advisory was associated with a 22-fold increase in the rate of reported adverse events. This increase in reporting likely represents both enhanced awareness of complications as well as an increase in vacuum-related adverse neonatal sequelae. As vacuum delivery is associated with greater neonatal morbidity/ mortality than was previously recognized, the adage that the vacuum is "designed to come off before infant damage occurs" appears unsubstantiated. It is recommended that manufacturers quantify the suction and traction capabilities of present and new proposed vacuum cup designs.
Parental questionnaires concerning the nine temperament variables studied in the New York longitudinal study have been developed for the measurement of children's temperament at six, 12 and 24 months of age. Retest reliability for the questionnaires was found to be generally satisfactory and at a level similar to that found in other temperament studies. The temperament characteristics of a large standardization sample, studied longitudinally over the three ages, showed little relation to the children's gender, birth order or social class. Factor analyses of the variables showed that two of the patterns were identical at 12 and 24 months of age: one pattern consisted of mood, approach, adaptability and distractibility, and the other of activity, approach and intensity. The standardization sample showed about the same rates of the 'difficult' and the 'slow-to-warm-up' temperament types, as found in early samples. The stability of the subjects' temperament scores over time was low to moderate, and a majority of the subjects changed their temperament type over the 18 months covered by the longitudinal study. The use of temperament questionnaires in clinical research is illustrated in three current studies.
The association between congenital major urinary tract anomalies (CMUTA) and spontaneous pneumothorax in term newborn infants (SPTNI) is controversial. We conducted a case-control study to test the hypothesis that SPTNI is associated with CMUTA. We compared 80 term infants with spontaneous pneumothorax to 80 healthy control infants. We recorded risk factors, clinical course, therapy, and outcome. Only 1 infant of 60 infants (1.7%) had CMUTA with SPTNI, as revealed by renal ultrasound studies. This is comparable to the 1.4% rate reported for CMUTA in healthy newborn infants by Steinhart et al. ([1988] Pediatrics 82:609-614). SPTNI were significantly more likely in males with higher birth weights and with vacuum delivery. Sixty-seven (84%) infants with SPTNI had follow-up for a mean and median of 46.4 and 39 months, respectively (range, 1-126 months), without manifesting any renal or pulmonary complications.
OBJECTIVE: To investigate the accuracy of intrapartum transvaginal digital examination in defining the position of the fetal head before instrumental delivery. PATIENTS AND METHODS: In 64 singleton pregnancies undergoing instrumental delivery the fetal head position was determined by transvaginal digital examination by the attending obstetrician. Immediately after or before the clinical examination, the fetal head position was determined by transabdominal ultrasound by a trained sonographer who was not aware of the clinical findings. The digital examination was considered to be correct if the fetal head position was within +/- 45 degrees of the ultrasound finding. The accuracy of the digital examination was examined in relation to maternal and fetal characteristics. RESULTS: Digital examination failed to define the correct fetal head position in 17 (26.6%) cases. In 12 of 17 (70.6%) errors the difference was >/= 90 degrees and in five (29.4%) the difference was between 45 degrees and 90 degrees. The accuracy of vaginal digital examination was 83% for occiput-anterior and 54% for occiput-lateral + occiput-posterior positions. Logistic regression analysis demonstrated significant independent contributions in explaining the variance in the accuracy of vaginal examination for the station of the fetal head, the position of the fetal head and the experience of the examining obstetrician. CONCLUSIONS: Digital examination during instrumental delivery fails to identify the correct fetal head position in about one quarter of cases.
Two new cases of leptomeningeal cysts subsequent to vacuum extraction are reported. Both children presented with a huge, nonpulsating, transilluminating subgaleal collection over the anterior fontanel that appeared soon after instrument delivery. Plain X-rays, computed tomography, and magnetic resonance imaging confirmed that the subgaleal collection was cerebrospinal fluid and showed the presence of a diastatic coronal suture in both cases. Treatment consisted of duraplasty with periosteal flaps and application of fibrin glue. In one case, an associated porencephalic cyst was treated with a cystoperitoneal shunt. Surgical treatment of leptomeningeal cyst due to vacuum extraction is simple and should not be postponed, despite the tendency for the extracranial cyst to regress, because of the potential risk of continuous growth of an underlying porencephalic cyst and risk of neurological damage.
Ten term newborns underwent CT of the brain 12-24 h following vacuum extractor delivery. Haemorrhage in the area of the tentorium was demonstrated in all of them, with similar findings in all cases. CT 1 week later demonstrated reabsorption of the blood without demonstrating any other brain pathology. Clinical and CT examination a year after delivery did not reveal any abnormality. The haemorrhage appears to be a benign condition.
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