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Subgaleal hemorrhage in a premature infant with congenital diaphragmatic hernia following vacuum-assisted delivery.

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.

Adult↗

Soft versus rigid vacuum extractor cups for assisted vaginal delivery.

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.

Female↗

Medical versus surgical methods for first trimester termination of pregnancy.

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.

Abortifacient Agents↗

Medical versus surgical methods for first trimester termination of pregnancy.

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.

Abortifacient Agents↗

Impact of FDA advisory on reported vacuum-assisted delivery and morbidity.

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.

Cerebral Hemorrhage↗

Temperament questionnaires in clinical research.

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.

Child, Preschool↗

Symptomatic spontaneous pneumothorax in term newborn infants.

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.

Case-Control Studies↗

Leptomeningeal cyst in newborns due to vacuum extraction: report of two 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.

Arachnoid Cysts↗

CT demonstration of intracranial haemorrhage in term newborn following vacuum extractor delivery.

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.

Birth Injuries↗

CT and MRI characteristics of intracranial hemorrhage complicating breech and vacuum delivery.

The CT/MRI brain findings and sequelae of intracranial hemorrhage resulting from traumatic breech and vacuum delivery of 16 term newborn infants are presented. Eleven infants were vacuum extracted, while the remaining five infants were delivered breech. Except for three breech-delivered infants who had intraventricular hemorrhage, the location and nature of hemorrhage were similar in both groups. Nine of the 11 vacuum-extracted babies showed complete resolution of hemorrhage on follow-up examination. None of the breech cases had a normal outcome. All five of the latter group had hydrocephalus, and one case each demonstrated porencephaly and encephalomalacia.

Birth Injuries↗

Leptomeningeal cyst: early diagnosis by color Doppler imaging.

A newborn with a leptomeningeal cyst over the anterior fontanelle due to birth trauma is described. Color Doppler flow sonograms were helpful to diagnose the leptomeningocele in its early stages and to differentiate it from a cephalhematoma or subgaleal haemorrhage by demonstrating cerebro-fugal flow in an arterial connection between the extracranial fluid collection and the dural space.

Arachnoid Cysts↗

"Growing fontanelle": a serious complication of difficult vacuum extraction.

Growing skull fractures in combination with leptomeningeal cysts are well known in childhood. A rare case of a growing fontanelle due to a leptomeningeal cyst is presented. The cyst occurred due to a traumatic delivery with vacuum extraction. Operative repair of the cyst revealed a dural tear at the border of the fontanelle. The imaging findings are discussed.

Arachnoid Cysts↗

Acute epidural hematoma related to cesarean section in a neonate with Chiari II malformation.

We present a rare case of acute epidural hematoma in a newborn infant with congenital hydrocephalus that was related to Chiari II malformation. The hematoma was attributed to the application of excessive suction with a vacuum extractor during cesarean section. The clinical characteristics of neonatal epidural hematoma were analyzed after a review of 18 cases in the literature, and diagnosis and treatment are discussed with reference to the results. We propose that careful follow-up is essential in neonates with cephalohematoma, and that a computed tomography (CT) study should be performed immediately if an infant's head circumference is discovered to be enlarging or if the anterior fontanel bulges.

Arnold-Chiari Malformation↗

The influence of vacuum extractor on fetal oxygenation and newborn status.

AIM: The aim of this study was to determine the effects of vacuum extractor assisted delivery on fetal oxygenation and acid-base balance. METHODS: Sixty-one women were enrolled in the present study. The subjects were divided into two groups. Group A, consisting of 39 women, had normal vaginal deliveries. Group B, consisting of 22 women, underwent a vacuum extractor assisted vaginal delivery. Fetal arterial oxygen saturation (SpO2) monitoring was used in all women after full cervical dilatation. After delivery, umbilical artery pH, pCO2, pO2 and base deficit (BDecf) levels were determined in all neonates. RESULTS: The mean FSpO2 value in Group A was 51.53+/-5.87% and in Group B 48.03+/-6.39% (p<0.03). The mean cord pH value in fetuses of Group A was 7.26+/-0.05, and in Group B 7.17+/-0.09. There was also a significant difference between the two groups with regards to mean pO2, pCO2 and BDecf values. CONCLUSIONS: Vacuum assisted vaginal delivery was associated with lower fetal arterial oxygen saturation levels as well as lower cord blood pH values compared to those seen after unassisted vaginal delivery. Although decreased, however, the above parameters remained within normal ranges.

Acid-Base Imbalance↗

Onset of vacuum-related complaints in neonates.

Since vacuum-related neonatal morbidity has been described in many studies clinical observation of neonates is common practice after vacuum-assisted vaginal delivery. However, no guidelines are available regarding the required length of hospital stay of these infants, because little is known about the first onset of complaints due to vacuum extraction-related morbidity. In a prospective observational cohort study we found that vacuum extraction-related complaints occurred in term neonates within 10 h following birth. Mild to moderate morbidity was frequently seen, whereas severe morbidity was infrequently seen. Previous artificial delivery, Apgar score lower than 7 at 1 min, and birth weight >4.0 kg were risk factors for morbidity after vacuum extraction. We suggest that it is justified to discharge neonates at least 10 h after vacuum delivery when no vacuum extraction-related complaints have occurred.

Apgar Score↗

Clinical effects of orally administered extracts of Montanoa tomentosa in early human pregnancy.

Freshly prepared aqueous decocts of the Mexican plant Montanoa tomentosa (Zoapatle) were administered orally to six women in the early stages of pregnancy for two days prior to the interruption of gestation by vacuum aspiration. The daily dose administered varied between 1.0 and 1.4 gm-equivalent of dry leaves per kilogram of body weight. A comparable control group of six pregnant women received the same volume of commercial tea according to the same schedule before vacuum aspiration. Administration of Zoapatle extracts resulted in a menstrual-like cramp and a significant dilatation of the cervix in all subjects studied. In four of the six subjects the menstrual-like pains were associated with bleeding. No comparable effects were observed in the control group. Peroral administration of Zoapatle decocts did not produce any cardiovascular changes, and it did not influence the hematologic status, liver, kidney, and thyroid function, blood lipids, proteins, and electrolyte status. Under the experimental conditions used, Zoapatle extracts did not induce a luteolytic effect judged from the plasma progesterone (and estradiol) levels. It is concluded that peroral administration of freshly prepared decocts of Zoapatle in early pregnancy exerts a distinct uterotonic effect and induces cervical dilatation and uterine bleeding. These changes are not associated with any effect on the plasma levels of progesterone and estradiol or with any untoward side effects.

Abortifacient Agents↗