A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set.

BACKGROUND: A core outcome set (COS) is required to address inconsistencies in outcome reporting in chronic pelvic pain (CPP) trials. OBJECTIVES: Evaluation of reported outcomes and selected outcome measures in CPP trials by producing a comprehensive inventory to inform a COS. SEARCH STRATEGY: Systematic review of randomised controlled trials (RCTs) identified from Cochrane Central Register of Controlled Trials (CENTRAL), Embase and MEDLINE databases. SELECTION CRITERIA: RCTs assessing efficacy and safety of medical, surgical and psychological interventions for women with idiopathic CPP. DATA COLLECTION AND ANALYSIS: Two independent researchers extracted outcomes and outcome measures. Similar outcomes were grouped and classified into domains to produce a structured inventory. MAIN RESULTS: Twenty-four trials were identified including 136 reported outcomes and outcome measures. Rates of reporting outcomes varied (4-100%) and pelvic pain was the most frequently reported outcome (100%). All trials reported the pain domain; however, only half reported quality of life, clinical effectiveness and adverse events. No differences in outcome reporting were observed in five high-quality trials (21%). Univariate analysis demonstrated an association between quality of outcome reporting and methodological quality of studies (rs  = 0.407, P = 0.048). CONCLUSION: There is wide variation in reported outcomes and applied outcome measures in CPP trials. While a COS is being developed and implemented, we propose the interim use of commonly reported outcomes in each domain: pain (pelvic pain, dyspareunia, dysmenorrhoea), life impact (quality of life, emotional functioning, physical functioning), clinical effectiveness (efficacy, satisfaction, cost effectiveness, return to daily activities) and adverse events (surgical, perioperative observations, nonsurgical). TWEETABLE ABSTRACT: There is significant variation in outcome reporting in CPP trials. Our systematic review forms the basis for the development of a core outcome set.

Mode of delivery and risk of respiratory diseases in newborns.

OBJECTIVE: To determine whether there is an increased incidence of persistent pulmonary hypertension in neonates delivered by cesarean, with or without labor, compared with those delivered vaginally. METHODS: We did a computerized retrospective review of 29,669 consecutive deliveries over 7 years (1992-1999). The incidences of persistent pulmonary hypertension of the newborn, transient tachypnea of the newborn, and respiratory distress syndrome (RDS) were tabulated for each delivery mode. Cases of persistent pulmonary hypertension were reviewed individually to determine delivery method and whether labor had occurred. The three groups defined were all cesarean deliveries, all elective cesareans, and all vaginal deliveries. RESULTS: Among 4301 cesareans done, 17 neonates had persistent pulmonary hypertension (four per 1000 live births). Among 1889 elective cesarean deliveries, seven neonates had persistent pulmonary hypertension (3.7 per 1000 live births). Among 21,017 vaginal deliveries, 17 neonates had persistent pulmonary hypertension (0.8 per 1000 live births). chi2 analysis showed an odds ratio 4.6 and P <.001 for comparison of elective cesarean and vaginal delivery for that outcome. CONCLUSION: The incidence of persistent pulmonary hypertension of the newborn was approximately 0.37% among neonates delivered by elective cesarean, almost fivefold higher than those delivered vaginally. The findings have implications for informed consent before cesarean and increased surveillance of neonates after cesarean.

Intrapartum antibiotic prophylaxis increases the incidence of gram-negative neonatal sepsis.

OBJECTIVE: To investigate the influence of the increased use of intrapartum chemoprophylaxis on the incidence of vertically transmitted neonatal sepsis. METHODS: Multiple institutional databases were queried for the number of cases in which intrapartum antibiotics were used, the obstetric risk factors that were present, and the number of resultant cases of neonatal sepsis that occurred for deliveries from 1992 through 1997. Intrapartum antibiotic use was compared between the first and fourth quarter of 1997. Comparisons were made between the years 1992-1996 and 1997 for the incidence of the various pathogens causing neonatal sepsis; group B streptococcus (GBS), gram-negative sepsis, and others. RESULTS: We found a significant increase in intrapartum chemoprophylaxis between the first and fourth quarters of 1997 corresponding to the increased physician awareness of published guidelines. As expected, the incidence of neonatal GBS sepsis was drastically reduced (from 1.7/1000 live births to 0 in 3730 births, P = 0.02). Unfortunately, there was a concomitant increase in the incidence of gram-negative sepsis (0.29/1000 vs. 1.3/1000, P = .02). The overall incidence of neonatal sepsis remained unchanged (2.7/1000 vs. 2.1/1000, P = .69). CONCLUSIONS: Published guidelines have encouraged physicians to increase the use of intrapartum chemoprophylaxis to reduce vertical transmission of GBS. This study confirms the efficacy of this approach. Unfortunately, this reduction comes at the cost of increasing the incidence of ampicillin-resistant gram-negative neonatal sepsis with a resultant increased mortality. These data provide compelling evidence that the policy of providing ampicillin chemoprophylaxis in selected patients needs to be reconsidered.

Pediatrician attendance at cesarean delivery: necessary or not?

OBJECTIVE: To determine whether it is necessary for a pediatrician to attend all cesarean deliveries. METHODS: We analyzed a database of 17,867 consecutive deliveries to determine the rates of low Apgar scores in the following three groups of patients: those with vaginal delivery, cesarean delivery using regional anesthesia without fetal indication, and cesarean delivery for fetal indications or using general anesthesia. RESULTS: There was a significantly higher rate of low Apgar scores in the fetal indications or general anesthesia group when compared with vaginal deliveries. Specifically, 35 (5.8%) of 596 cesareans for fetal heart rate abnormality or using general anesthesia had 1-minute Apgars under 4 in contrast to 115 of 10,270 (1.1%) of vaginal deliveries. There was no significantly increased risk for low Apgar scores in the group of cesareans using regional anesthesia for nonfetal indications (33 of 2057, 1.6%). Results were similar for Apgar scores under 7 at 5 minutes. CONCLUSION: Because there is no higher incidence of low Apgar scores in cesarean deliveries using regional anesthesia for nonfetal indications compared with vaginal deliveries, there is no convincing need for pediatrician attendance at such deliveries.

Intrapartum management relating to the risk of perinatal transmission of group B streptococcus.

OBJECTIVE: To review the incidence of neonatal group B streptococcal (GBS) sepsis and its associated risk factors in our obstetrical population. METHODS: A computerized perinatal database of over 17,000 births (from 1992 to 1996) was queried for the incidence of neonatal GBS sepsis. A more detailed review of 895 births (from the first quarter of 1997) was undertaken to identify the incidence of risk factors known to be associated with neonatal GBS sepsis. RESULTS: In our institution, 30 cases of neonatal early-onset GBS sepsis were identified in over 17,000 births (or 1.7/1,000 deliveries). Risk factors were identified in 17 of those cases (56%). There were two neonatal fatalities. Chemoprophylaxis was provided in 15% of the total deliveries. CONCLUSIONS: In spite of the lack of a uniform policy for identifying patients suitable for GBS chemoprophylaxis, we found only a 43% incidence of neonatal GBS sepsis occurring without risk factors present. Identification of antepartum or intrapartum risk factors in our series, therefore, would have identified the majority of cases resulting in neonatal GBS sepsis, which may have benefited from intrapartum therapy. Some negative potential consequences of chemoprophylaxis are discussed, raising questions regarding the recent recommendations of the Centers for Disease Control and Prevention.

Improvement in oxygen tensions and pulmonary blood flow with intermittent distal aortic compression during normoxia, hypoxic hypoxia, and hyperoxia in neonatal piglets.

BACKGROUND AND METHODS: We investigated the hypothesis that, in a newborn piglet during normoxia, hypoxia, and hyperoxia, increasing aortic pressure transiently by intermittent short-duration aortic compression would affect left-to-right shunting of blood and thus increase pulmonary artery blood flow, pulmonary arterial PO2, and aortic PO2 proximal to the point of compression. We also investigated whether a balloon atrial septostomy, by providing an open channel for communication between the right- and left-sided circulations, would further improve pulmonary blood flow and aortic PO2. Studies were performed in eight 7- to 10-day-old newborn piglets in three phases (FIO2 of 0.21, 0.12, and 1.0) before and after balloon arterial septostomy in each piglet. Blood gas measurements and hemodynamic variables were recorded before and at the end of a 30-sec period of aortic compression. RESULTS: During aortic compression, all the animals demonstrated a 50 to 70 mm Hg increase in aortic pressure proximal to the compression. Before balloon septostomy, there were 21%, 41%, and 8% increases in aortic PO2 in the room air, hypoxic, and hyperoxic phases of the experiment, respectively. There were also statistically significant increments in pulmonary blood flow and arterial pressures. After balloon septostomy, there were 35%, 25%, and 21% increments in aortic PO2 during the room air, hypoxic, and hyperoxic phases of the experiment, respectively. However, there was no statistically significant further improvement in the effects of aortic compression on PO2 with septostomy compared with those effects before septostomy. CONCLUSIONS: Our results suggest that increasing systemic arterial pressures in order to forcibly affect left-to-right shunting of blood may be potentially beneficial in the management of hypoxia in situations where low pulmonary artery blood flow may be contributing to hypoxia, e.g., in persistent pulmonary hypertension of the newborn.

In vivo distribution of human milk leucocytes after ingestion by newborn baboons.

The in vivo distribution of enterally administered human milk leucocytes labelled with indium hydroxyquinoline (111In) was studied in premature baboons. The animals were killed at 72 hours of age and tissue samples examined for radioactivity. Maximum activity was found in the luminal contents, and activity in the liver and spleen was higher than in bone marrow, the site where free isotope is normally deposited. These findings suggest that some intact milk leucocytes may cross from the gastrointestinal tract into the neonatal circulation. Also the high activity in gastrointestinal tissue that had been washed several times indicates that leucocytes adhere to mucosa or lie intramurally. We speculate that the presence of leucocytes in the gastrointestinal tract 60 hours after a single breast feed can provide an important defence mechanism against infection.

Circle of Willis blood velocity and flow direction after common carotid artery ligation for neonatal extracorporeal membrane oxygenation.

The velocity and direction of blood flow in the circle of Willis arteries were measured in three infants who underwent right common carotid artery ligation for extracorporeal membrane oxygenation treatment. Within 15 minutes of common carotid artery ligation, blood flow was detected in one infant's right middle cerebral artery; however, the velocity was reduced to 50% of the preextracorporeal membrane oxygenation level. The velocity remained 50% to 70% lower than normal during the 88 hours of extracorporeal membrane oxygenation therapy. In the other two infants, the velocity changes were less severe. By 2 to 10 weeks after weaning from extracorporeal membrane oxygenation, the velocities in the left cerebral arteries were increased to 116% to 217% of the corresponding right cerebral vessels. Following common carotid artery ligation, a retrograde direction of flow was noted in the first (A1) segment of the right anterior cerebral artery and in the right posterior communicating artery, whereas the direction of flow was normal in the corresponding vessels on the left. After common carotid artery ligation, the vertebrobasilar and the contralateral internal carotid systems appear to be the main sources of reperfusion of the right cerebral hemisphere via the circle of Willis. Furthermore, because of the known variants of the circle anatomy, a noninvasive pulsed Doppler method could be used to evaluate the flow patterns in the circle of Willis arteries, both before and after common carotid artery ligation for extracorporeal membrane oxygenation.

Morbidity and mortality factors in twins. An epidemiologic approach.

Some epidemiologic characteristics of twin pregnancies and twin infants have been reviewed. We found that twins are prone to be born prematurely and have lower birth weights than their singleton counterparts after 30 to 34 weeks of gestation. Twins are also more prone to birth asphyxia, hyaline membrane disease, respiratory disorders, and seizures. Congenital anomalies and nonrespiratory morbidity were not found to be increased in twins. Twins have a six times higher perinatal mortality rate than do singletons. This is accounted for by prematurity in the main. A part of the excess mortality in twins is accounted for by a higher mortality in larger, near-term twins. Efforts should be directed toward decreasing the incidence of prematurity in twins and understanding and managing the problems of near-term twins better.