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PubMed1983

Risk, protective factors, and supportive interventions in chronic airway obstruction.

Fifty-nine patients with chronic airway obstruction completed the Schedule of Recent Experiences and Social Assets Scale (SAS) to measure life stress and social supports. Patients with highest stress and lowest SAS scores (the high-risk group) were randomly assigned to a pulmonary rehabilitation group, self-help support group, or waiting-list control group. Patients with lower stress and/or higher SAS scores (the low-risk group) served as controls. Six months later, a records review showed that high-risk control patients were hospitalized more often than low-risk control patients and for more days than high-risk patients in rehabilitation and self-help support groups. Discriminant analysis determined that SAS and life stress scores predicted subsequent hospitalization, but age, sex, previous hospitalizations, and severity of illness did not. Measurements of stress and social supports can help identify high-risk patients. In turn, professionals might assist these patients by increasing their supports.

Female↗

PubMed2001

Hormone replacement therapy and cognition: systematic review and meta-analysis.

CONTEXT: Some observational data suggest that hormone replacement therapy (HRT) may reduce the risk of cognitive decline and dementia but results have been conflicting. OBJECTIVE: To review and evaluate studies of HRT for preventing cognitive decline and dementia in healthy postmenopausal women. DATA SOURCES: Studies with English-language abstracts identified in MEDLINE (1966-August 2000), HealthSTAR (1975-August 2000, PsychINFO (1984-August 2000); Cochrane Library databases; and articles listed in reference lists of key articles. STUDY SELECTION: Randomized controlled trials and cohort studies were reviewed for the effects of HRT on cognitive decline; cohort and case-control studies were reviewed for dementia risk. No randomized controlled trials regarding dementia risk were identified. DATA EXTRACTION: Twenty-nine studies met inclusion criteria and were rated. Two reviewers rated study quality independently and 100% agreement was reached on Jadad scores and 80% agreement was reached on US Preventive Services Task Force quality scores. A final score was reached through consensus if reviewers disagreed. DATA SYNTHESIS: Studies of cognition were not combined quantitatively because of heterogeneous study design. Women symptomatic from menopause had improvements in verbal memory, vigilance, reasoning, and motor speed, but no enhancement of other cognitive functions. Generally, no benefits were observed in asymptomatic women. A meta-analysis of observational studies suggested that HRT was associated with a decreased risk of dementia (summary odds ratio, 0.66; 95% confidence interval, 0.53-0.82). However, possible biases and lack of control for potential confounders limit interpretation of these studies. Studies did not contain enough information to assess adequately the effects of progestin use, various estrogen preparations or doses, or duration of therapy. CONCLUSIONS: In women with menopausal symptoms, HRT may have specific cognitive effects, and future studies should target these effects. The meta-analysis found a decreased risk of dementia in HRT users but most studies had important methodological limitations.

Bayes Theorem↗

PubMed2005

Duration of anticoagulation following venous thromboembolism: a meta-analysis.

CONTEXT: Patients with venous thromboembolism (VTE) are susceptible to recurrent events, but whether prolonging anticoagulation is warranted in patients with VTE remains controversial. OBJECTIVE: To review the available evidence and quantify the risks and benefits of extending the duration of anticoagulation in patients with VTE. DATA SOURCES: PubMed, EMBase Pharmacology, the Cochrane database, clinical trial Web sites, and a hand search of reference lists. STUDY SELECTION: Included studies were randomized controlled trials with results published from 1969 through 2004 and evaluating the duration of anticoagulation in patients with VTE that measured recurrent VTE. Excluded studies were those enrolling only pure populations of high-risk patients. Two independent reviewers assessed each article for inclusion and exclusion criteria, with adjudication by a third reviewer in cases of disagreement. Fifteen of 67 studies were included in the analysis. DATA EXTRACTION: Two independent reviewers performed data extraction using a standardized form, with adjudication by the remainder of the investigators in cases of disagreement. Data regarding recurrent VTE, major bleeding, person-time at risk, and study quality were extracted. DATA SYNTHESIS: If patients in the long-term therapy group remained receiving anticoagulation, the risk of recurrent VTE with long- vs short-term therapy was reduced (weighted incidence rate, 0.020 vs 0.126 events/person-year; rate difference, -0.106 [95% confidence interval {CI}, -0.145 to -0.067]; P<.001; pooled incidence rate ratio [IRR], 0.21 [95% CI, 0.14 to 0.31]; P<.001). If anticoagulation in the long-term therapy group was discontinued, the risk reduction was less pronounced (weighted incidence rate, 0.052 vs 0.072 events/person-year; rate difference, -0.020 [95% CI, -0.039 to -0.001]; P = .04; pooled IRR, 0.69 [95% CI, 0.53 to 0.91]; P = .009). The risk of major bleeding with long- vs short-term therapy was similar (weighted incidence rate, 0.011 vs 0.006 events/person-year; rate difference, 0.005 [95% CI, -0.002 to 0.011]; P = .14; pooled IRR, 1.80 [95% CI, 0.72 to 4.51]; P = .21). CONCLUSIONS: Patients who receive extended anticoagulation are protected from recurrent VTE while receiving long-term therapy. The clinical benefit is maintained after anticoagulation is discontinued, but the magnitude of the benefit is less pronounced.

Anticoagulants↗

PubMed2001

Mechanical methods for induction of labour.

BACKGROUND: Mechanical methods were the first methods developed to ripen the cervix or to induce labour. Devices which were used include various type of catheters and of laminaria tents, introduced into the cervical canal or into the extra-amniotic space. Mechanical methods were never completely abandoned, but were substituted by pharmacological methods during recent decades. Potential advantages of mechanical methods, compared with pharmacological methods, may include simplicity of preservation, lower cost and reduction of the side effects. However, special attention should be paid to contraindications (e.g. low-lying placenta), risk of infection and maternal discomfort when inserting these devices. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of mechanical methods for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment, prostaglandins (vaginal, intracervical, misoprostol) and oxytocin. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched April 2001. SELECTION CRITERIA: The criteria for inclusion were the following: (1) clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate or unclear method for allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data will be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. MAIN RESULTS: In total, 58 studies were considered; 45 studies have been included and 13 were excluded. Studies generally included women with unfavourable cervix and intact membranes. Comparing mechanical methods with placebo/no treatment, only one study with 48 participants reported on vaginal delivery not achieved in 24 hours (69% with mechanical methods versus 77% with placebo/no treatment; relative risk (RR) 0.90; 95% confidence interval (CI): 0.64-1.26). Hyperstimulation with fetal heart rate changes was not reported. The risk of caesarean section, reported in six studies including 416 women, was similar between groups (34%; RR 1.00; 95% CI: 0.76-1.30). There were no reported cases of severe neonatal and maternal morbidity. Comparing mechanical methods with vaginal PGE2, only one trial (109 women) reported on vaginal delivery not achieved in 24 hours (73% versus 42%; relative risk (RR) 1.74; 95% CI: 1.21-2.49). Compared with intracervical PGE2, only one trial (100 women) reported on vaginal delivery not achieved in 24 hours (68% versus 40%; relative risk (RR) 1.70; 95% CI: 1.15-2.51). Compared with with misoprostol, the effectiveness of mechanical methods was similar (34% versus 30%; relative risk (RR) 1.15; 95% CI: 0.80-1.66). The use of mechanical method reduced the risk of hyperstimulation with fetal heart rate changes when compared with prostaglandins: vaginal PGE2 (0% versus 6%; RR 0.14; 95% CI: 0.04-0.53), intracervical PGE2 (0% versus 1%; RR 0.21; 95% CI: 0.04-1.20) and misoprostol (4% versus 9%; RR 0.41; 95% CI: 0.20-0.87). There was no difference in the risk of caesarean section between mechanical methods and prostaglandins. Serious neonatal (three cases) and maternal morbidity (one case) were infrequently reported. When compared with oxytocin, use of mechanical methods reduced the risk of caesarean section (4 trials; 198 women; 17% versus 32%; RR 0.55; 95% CI: 0.33-0.91). The likelihood of vaginal delivery in 24 hours and of hyperstimulation with fetal heart rate changes was not reported. There were no reported cases of serious maternal morbidity and severe neonatal morbidity was not reported. These results are similar whatever specific mechanical method was used, except with extra-amniotic infusion. When comparing extra-amniotic infusion with any prostaglandins, women were more likely to not achieve vaginal delivery within 24 hours (57% versus 42%; RR 1.33; 95% CI: 1.02-1.75), the risk of caesarean section was increased (31% versus 22%; RR 1.48; 95% CI: 1.14-1.90), without a reduction of the risk of hyperstimulation. REVIEWER'S CONCLUSIONS: There is insufficient evidence to evaluate the effectiveness, in terms of likelihood of vaginal delivery in 24 hours, of mechanical methods compared with placebo/no treatment or with prostaglandins. The risk of hyperstimulation was reduced when compared with prostaglandins (intracervical, intravaginal or misoprostol). Compared to oxytocin in women with unfavourable cervix, mechanical methods reduce the risk of caesarean section. There is no evidence to support the use of extra-amniotic infusion.

Catheterization↗

PubMed2001

Budesonide for maintenance of remission in Crohn's disease.

OBJECTIVES: The primary objective was to precisely derive an estimate of the efficacy of oral budesonide for the maintenance of remission in Crohn's disease. SEARCH STRATEGY: Medline 1966-September 2000 was searched using the text and key words "oral budesonide", "Crohn's disease", "Crohn disease", and "inflammatory bowel disease". Proceedings from the American Gastroenterology Association conference (1980-1998) were hand searched. Additionally, the Cochrane Controlled Trials Register and the Inflammatory Bowel Disease Review Group Trials Registers were also searched. The manufacturer of oral budesonide was also contacted, as were some of the local trialists involved in the oral budesonide trials. Relevant articles were retrieved, and their reference lists were also reviewed. SELECTION CRITERIA: Randomized controlled trials of oral budesonide in which patients at entry were in remission with a Crohn's Disease Activity Index (CDAI) <= 150, and had disease restricted to the ileum and colon. DATA COLLECTION AND ANALYSIS: The primary outcome was the relative risk (RR) of relapse (and 95% confidence interval [CI]) during the 12 months of treatment, as defined by the number of patients who relapsed, and the number of patients who entered the trial. The numbers needed to treat were also derived. MAIN RESULTS: Three randomized controlled trials of oral budesonide (controlled ileal release preparation) 6 mg/day, 3mg/day and placebo for a one year period were included in the analysis. Budesonide 6 mg/day was not effective at preventing relapse of Crohn's disease over the 12 months of treatment. The relative risk of relapse was 0.89 (95% CI: 0.71-1.13) comparing budesonide 6 mg/day and placebo. Similar results were also observed in the comparison of budesonide 6 mg/day with budesonide 3 mg/day; the relative risk of relapse was 0.89 (95% CI: 0.70-1.11). The 3 mg/day dose was similarly found to be ineffective at preventing relapse during the 12 months of treatment; the relative risk of relapse was 1.00 (95% CI: 0.80-1.24). The results of the analysis of relative risk of relapse were supported by the analysis of withdrawal due to treatment failure. The relative risks for withdrawal due to treatment failure for budesonide 6 mg/day compared with placebo was 0.85 (95% CI: 0.65-1.10), for budesonide 3 mg/day compared with placebo was 0.94 (95% CI: 0.73-1.20), and for budesonide 6 mg/day compared with budesonide 3 mg/day was 0.89 (95% CI: 0.68-1.17). REVIEWER'S CONCLUSIONS: Oral budesonide therapy at 6 mg/day is not effective in preventing relapses of Crohn's disease.

Administration, Oral↗

PubMed2001

Extra-amniotic prostaglandin for induction of labour.

BACKGROUND: This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of extra-amniotic prostaglandin for third trimester cervical ripening or induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Date of last search: December 2000. SELECTION CRITERIA: (1) clinical trials comparing extra-amniotic prostaglandin used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This has involved a two-stage method of data extraction. The initial data were extracted centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. MAIN RESULTS: Oxytocin was used to initiate or augment labour significantly less frequently with extra-amniotic prostaglandins when compared to placebo (relative risk 0.50, 95% confidence interval 0.38-0.66). No other findings were significant in the comparisons that were made for this review including when extra-amniotic prostaglandins were compared with other methods of cervical ripening or induction of labour. Although this could suggest that extra-amniotic prostaglandins are as effective as other agents, the findings are difficult to interpret because they are based on very small numbers and may lack the power to show a real difference. REVIEWER'S CONCLUSIONS: The studies in this review are limited by their small sample sizes which are in many cases further divided into multiple comparison groups. The analyses resulted in most comparisons showing no significant differences, with wide confidence intervals. Although extra-amniotic prostaglandins may be as effective as other modalities in initiating labour, there is little conclusive information from this review to guide clinical practice. An adequately powered randomised controlled trial would be useful to determine if the use of extra-amniotic prostaglandins would lower the rate of caesarean section. However, in the time since these studies were undertaken the use of extra-amniotic prostaglandins has largely been replaced by other modes of prostaglandin administration.

Cervical Ripening↗

PubMed2001

Sexual intercourse for cervical ripening and induction of labour.

BACKGROUND: The role of prostaglandins for cervical ripening and induction of labour has been examined extensively. Human semen is the biological source that is presumed to contain the highest prostaglandin concentration. The role of sexual intercourse in the initiation of labour is uncertain. The action of sexual intercourse in stimulating labour is unclear, it may in part be due to the physical stimulation of the lower uterine segment, or endogenous release of oxytocin as a result of orgasm or from the direct action of prostaglandins in semen. Furthermore nipple stimulation may be part of the process of initiation. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of sexual intercourse for third trimester cervical ripening or induction of labour in comparison with other methods of induction. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. SELECTION CRITERIA: (1) clinical trials comparing sexual intercourse for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusion. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. MAIN RESULTS: There was one included study of 28 women which reported very limited data, from which no meaningful conclusions can be drawn. REVIEWER'S CONCLUSIONS: The role of sexual intercourse as a method of induction of labour is uncertain. Any future trials investigating sexual intercourse as a method of induction need to be of sufficient power to detect clinically relevant differences in standard outcomes. However, it may prove difficult to standardise sexual intercourse as an intervention to allow meaningful comparisons with other methods of induction of labour.

Cervical Ripening↗

PubMed2001

Hyaluronidase for cervical priming and induction of labour.

BACKGROUND: Dilatation and effacement of the cervix are not only a result of uterine contractions, but are also dependent upon ripening processes within the cervix. The cervix is a fibrous organ composed principally of hyaluronic acid, collagen and proteoglycan. Hyaluronic acid increases as pregnancy progresses, increases markedly after the onset of labour and decreases rapidly after birth of the infant. An increase in the level of hyaluronic acid is associated with an increase in tissue water content. Cervical ripening during labour is characterised by changes of the cervix with softening of the tissue and an increased water content. Cervical injection of hyaluronidase was postulated to increase cervical ripening. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of hyaluronidase for third trimester cervical ripening or induction of labour in comparison with other methods of induction of labour SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. SELECTION CRITERIA: (1) clinical trials comparing hyaluronidase used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. MAIN RESULTS: There were no included trials. REVIEWER'S CONCLUSIONS: The role of hyaluronidase as a method of cervical priming or induction of labour is uncertain.

Cervical Ripening↗

PubMed2001

Castor oil, bath and/or enema for cervical priming and induction of labour.

BACKGROUND: Castor oil, a potent cathartic, is derived from the bean of the castor plant. Anecdotal reports, which date back to ancient Egypt have suggested the use of castor oil to stimulate labour. Castor oil has been widely used as a traditional method of initiating labour in midwifery practice. Its role in the initiation of labour is poorly understood and data examining its efficacy within a clinical trial are limited. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of castor oil or enemas for third trimester cervical ripening or induction of labour in comparison with other methods of cervical ripening or induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. SELECTION CRITERIA: (1) clinical trials comparing castor oil, bath or enemas used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. MAIN RESULTS: In the one included study of 100 women, which compared a single dose of castor oil versus no treatment, no difference was found between caesarean section rates (relative risk (RR) 2.31, 95% CI 0.77, 6.87). No data were presented on neonatal or maternal mortality or morbidity. There was no difference between either the rate of meconium stained liquor (RR 0.77, 95% CI 0.25,2.36) or Apgar score < 7 at 5 minutes (RR 0.92, 95% CI 0.02,45.71) between the two groups. The number of participants was small hence only large differences in outcomes could have been detected. All women who ingested castor oil felt nauseous. REVIEWER'S CONCLUSIONS: The only trial included in this review attempts to address the role of castor oil as an induction agent. The trial was small and of poor methodological quality. Further research is needed to attempt to quantify the efficacy of castor oil as an induction agent.

Castor Oil↗

PubMed2001

Corticosteroids for induction of labour.

BACKGROUND: The role of corticosteroids in the process of labour is not well understood. Animal studies have shown the importance of cortisol secretion by the fetal adrenal gland in initiating labour in sheep. Infusion of glucocorticosteroids into the fetus has also shown to induce premature labour in sheep. Some assumptions have been proposed regarding the mode of action of corticosteroids, including both a paracrine and autocrine action, following the identification of glucocorticoid receptors on human amnion. Given these studies it has been postulated that corticosteroids given intraamniotically will promote the induction of labour. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of corticosteroids for third trimester cervical ripening or induction of labour in comparison with other methods of cervical priming or induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. SELECTION CRITERIA: (1) clinical trials comparing corticosteroids used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. MAIN RESULTS: There are no included trials, hence no results are presented. REVIEWER'S CONCLUSIONS: The effectiveness of corticosteroids for induction of labour is uncertain. Use of this method of induction of labour is not commonly used and further research in this area is probably unwarranted.

Administration, Topical↗

PubMed2001

Relaxin for cervical ripening and induction of labour.

BACKGROUND: Relaxin is a protein hormone composed of two amino acid chains. The role played by relaxin in human pregnancy and parturition is unclear. Its use and involvement as a cervical ripening agent has been debated since the 1950s. Because the main source of human relaxin is the corpus luteum of pregnancy much of the early work on induction of labour has focused on porcine or bovine preparations. With the advent of DNA recombinant technology human relaxin has become available for evaluation. Relaxin is thought to have a promoting effect on cervical ripening. Due to a possible inhibitory effect on human myometrial activity, relaxin may not be associated with the concomitant increase in the rate of uterine hyperstimulation seen with other induction agents. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology. OBJECTIVES: To determine the effects of relaxin (both purified porcine and recombinant human) for third trimester cervical ripening or induction of labour in comparison with other methods of induction. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled trials register and bibliographies of relevant papers. Last searched: November 2000. SELECTION CRITERIA: (1) clinical trials comparing relaxin used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusion. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. MAIN RESULTS: In total, nine studies were considered; five have been excluded and four included examining a total of 267 women. There were no reported cases of uterine hyperstimulation with fetal heart rate changes in any of the studies. The rate of caesarean section was not different in those women given relaxin compared with placebo (15.3% versus 14.2%; relative risk (RR) 0.79, 95% confidence interval (CI) 0.42,1.50). There was a reduction in the risk of the cervix remaining unfavourable or unchanged with induction with relaxin (21.9% versus 49.3%; RR 0.45, 95% CI 0.28,0.72). There were no reported cases of uterine hyperstimulation without FHR changes. REVIEWER'S CONCLUSIONS: The place of relaxin, either purified porcine or recombinant human, as an induction or cervical priming agent is unclear. Further trials are needed to estimate the true effect of relaxin within current clinical practice.

Animals↗

PubMed2001

Intravenous oxytocin alone for cervical ripening and induction of labour.

BACKGROUND: Oxytocin is the commonest induction agent used worldwide. It has been used alone, in combination with amniotomy or following cervical ripening with other pharmacological or non-pharmacological methods. Prior to the introduction of prostaglandin agents oxytocin was used as a cervical ripening agent as well. In developed countries oxytocin alone is more commonly used in the presence of ruptured membranes whether spontaneous or artificial. In developing countries where the incidence of HIV is high, delaying amniotomy in labour reduces vertical transmission rates and hence the use of oxytocin with intact membranes warrants further investigation. This review will address the use of oxytocin alone for induction of labour. Amniotomy alone or oxytocin with amniotomy for induction of labour has been reviewed elsewhere in the Cochrane Library. Trials which consider concomitant administration of oxytocin and amniotomy will not be considered. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology. OBJECTIVES: To determine the effects of oxytocin alone for third trimester cervical ripening or induction of labour in comparison with other methods of induction of labour or placebo/no treatment. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: May 2001. SELECTION CRITERIA: The criteria for inclusion included the following: (1) clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data is to be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. MAIN RESULTS: In total, 110 trials were considered; 52 have been excluded and 58 included examining a total of 11,129 women. Comparing oxytocin alone with expectant management: Oxytocin alone reduced the rate of unsuccessful vaginal delivery within 24 hours when compared with expectant management (8.3% versus 54%, relative risk (RR) 0.16, 95% confidence interval (CI) 0.10,0.25) but the caesarean section rate was increased (10.4% versus 8.9%, RR 1.17, 95% CI 1.01,1.36). This increase in caesarean section rate was not apparent in the subgroup analyses. Women were less likely to be unsatisfied with induction rather than expectant management, in the one trial reporting this outcome (5.5% versus 13.7%, RR 0.43, 95% CI 0.33, 0.56). Comparing oxytocin alone with vaginal prostaglandins: Oxytocin alone was associated with an increase in unsuccessful vaginal delivery within 24 hours (52% versus 28%, RR 1.85, 95% CI 1.41, 2.43), irrespective of membrane status, but there was no difference in caesarean section rates (11.4% versus 10%, RR 1.12, 95% CI 0.95, 1.33). Comparing oxytocin alone with intracervical prostaglandins: Oxytocin alone was associated with an increase in unsuccessful vaginal delivery within 24 hours when compared with intracervical PGE2 (51% versus 35%, RR 1.49, 95% CI 1.12,1.99). For all women with an unfavourable cervix regardless of membrane status, the caesarean section rates were increased (19.0% versus 13.1%, RR 1.42, 95% CI 1.11, 1.82). REVIEWER'S CONCLUSIONS: Overall, comparison of oxytocin alone with either intravaginal or intracervical PGE2 reveals that the prostaglandin agents probably overall have more benefits than oxytocin alone. The amount of information relating to specific clinical subgroups is limited, especially with respect to women with intact membranes. Comparison of oxytocin alone to vaginal PGE2 in women with ruptured membranes reveals that both interventions are probably equally efficacious with each having some advantages and disadvantages over the others. With respect to current practice in women with ruptured membranes induction can be recommended by either method and in women with intact membranes there is insufficient information to make firm recommendations.

Cervical Ripening↗

PubMed2001

Amniotomy plus intravenous oxytocin for induction of labour.

BACKGROUND: Induction of labour is a common obstetric intervention. Amniotomy alone for induction of labour is reviewed separately and oxytocin alone for induction of labour is being prepared for inclusion in The Cochrane Library. This review will address the use of the combination of these two methods for induction of labour in the third trimester. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine, from the best available evidence, the efficacy and safety of amniotomy and intravenous oxytocin for third trimester induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register and reference lists of articles were searched. Date of last search: May 2001. SELECTION CRITERIA: The criteria for inclusion included the following: (1) clinical trials comparing amniotomy plus intravenous oxytocin used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done by both reviewers. A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data is to be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. MAIN RESULTS: Seventeen trials involving 2566 women were included. Amniotomy and intravenous oxytocin were found to result in fewer women being undelivered vaginally at 24 hours than amniotomy alone (relative risk (RR) 0.03, 95% confidence intervals (CI) 0.001-0.49). This finding was based on the results of a single study of 100 women. As regards secondary results amniotomy and intravenous oxytocin resulted in significantly fewer instrumental vaginal deliveries than placebo (RR 0.18, CI 0.05-0.58). Amniotomy and intravenous oxytocin resulted in more postpartum haemorrhage than vaginal prostaglandins (RR 5.5, CI 1.26-24.07). Significantly more women were also dissatisfied with amniotomy and intravenous oxytocin when compared with vaginal prostaglandins, RR 53, CI 3.32-846.51. REVIEWER'S CONCLUSIONS: Data on the effectiveness and safety of amniotomy and intravenous oxytocin are lacking. No recommendations for clinical practice can be made on the basis of this review. Amniotomy and intravenous oxytocin is a combination of two methods of induction of labour and both methods are utilised in clinical practice. If their use is to be continued it is important to compare the effectiveness and safety of these methods, and to define under which clinical circumstances one may be preferable to another.

Amnion↗

PubMed2002

High first dose quinine regimen for treating severe malaria.

BACKGROUND: Quinine is used for treating severe malaria. There are arguments for giving an initial high dose. We examined the evidence for and against this policy. OBJECTIVES: To assess clinical outcomes and adverse events of a high first (loading) dose regimen of quinine with a uniform (no loading) dose regimen in people with severe malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group specialized trials register (May 2002), The Cochrane Controlled Trials Register (Issue 2, 2002), MEDLINE (1966 to April 2002), EMBASE (1988 to March 2002), LILACS (www.bireme.br; accessed February 2002), and conference proceedings for relevant abstracts. We also contacted researchers working in the field and checked the reference lists of all studies. SELECTION CRITERIA: Randomized controlled trials. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of the trials and extracted data. Review Manager (Version 4.1) was used to analyse the data: Relative Risk for binary data and weighted mean difference (WMD) for continuous data. Study authors were contacted for additional information. MAIN RESULTS: Three small trials, with two contributing to a meta-analysis of 72 participants. Loading dose was associated with fewer deaths, but this was not statistically significant (RR 0.43; 95% confidence interval (CI) 0.09 to 2.15). Loading dose was associated with faster clearance of parasites (WMD 7.44; 95% CI 1.64 to 13.2 hours), resolution of fever (WMD 11.11; 95% CI 2.18 to 20.04 hours), and transient hearing loss (RR 3.14; 95% CI 1.05 to 9.38). No significant difference was detected for recovery of consciousness, neurological sequelae, or convulsions, but the numbers were small. REVIEWER'S CONCLUSIONS: Quinine loading dose reduced fever clearance time and parasite clearance time. Data are insufficient to confirm or refute whether a loading dose reduced the risk of death or convulsions.

Adult↗

PubMed2004

High first dose quinine regimen for treating severe malaria.

BACKGROUND: Quinine is used for treating severe malaria. There are arguments for giving an initial high dose. We examined the evidence for and against this policy. OBJECTIVES: To assess the clinical outcomes and adverse events of a high first (loading) dose regimen of quinine compared with a uniform (no loading) dose regimen in people with severe malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group's trials register (April 2004), CENTRAL (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to April 2004), EMBASE (1974 to April 2004), LILACS (1982 to April 2004), and conference proceedings for relevant abstracts. We also contacted researchers working in the field and checked the reference lists of all studies. SELECTION CRITERIA: Randomized controlled trials comparing a high first (loading) dose of intravenous quinine with a uniform (no loading) dose of intravenous quinine in people with severe malaria. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of the trials and extracted data (including adverse event data). We used Review Manager 4.2 to analyse the data: relative risk (RR) for binary data and weighted mean difference (WMD) for continuous data with 95% confidence intervals (CI). We contacted study authors for additional information. MAIN RESULTS: Four trials (n = 144) met the inclusion criteria. Loading dose was associated with fewer deaths, but this was not statistically significant (RR 0.62, CI 0.19 to 2.04, 3 trials). Loading dose was associated with faster clearance of parasites (WMD -7.44 hours, CI -13.24 to -1.64 hours, 2 trials), resolution of fever (WMD -11.11 hours, CI -20.04 to -2.18 hours, 2 trials). No statistically significant difference was detected for recovery of consciousness, neurological sequelae, or convulsions, but the numbers were small. REVIEWERS' CONCLUSIONS: Quinine loading dose reduced fever clearance time and parasite clearance time. Data are insufficient to directly demonstrate an impact of loading dose on risk of death.

Adult↗

PubMed2001

Breast stimulation for cervical ripening and induction of labour.

BACKGROUND: Breast stimulation has been suggested as an effective means of inducing labour. It is both an inexpensive and non-medical intervention which allows women greater control over the induction process. It is not clear how breast stimulation increases uterine contractions, however it has been shown to be effective for contraction stress tests and for the augmentation of labour. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology. OBJECTIVES: To determine the effectiveness of breast stimulation for third trimester cervical ripening or induction of labour in comparison with placebo/no intervention or other methods of induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: April 2001. SELECTION CRITERIA: (1) randomised controlled trials comparing breast stimulation used for third trimester cervical ripening or labour induction with no intervention or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or the control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaning outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A generic strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally. MAIN RESULTS: Six randomised controlled trials were included in the analysis involving 719 women. When trials comparing breast stimulation with no intervention were analysed there was a significant reduction in the number of women not in labour at 72 hours (62.7% versus 93.6%, relative risk (RR) 0.67, 95% confidence interval (CI) 0.60 - 0.74). However, this result did not remain significant in women with an unfavourable cervix. There were no instances of uterine hyperstimulation. A reduction in the rate of postpartum haemorrhage was reported (0.7% versus 6%, RR 0.16, 95% CI 0.03 - 0.87). No significant difference was detected in the caesarean section rate (9% versus 10%, relative risk RR 0.90, 95% CI 0.38 - 2.12) or rates of meconium staining. Three perinatal deaths were reported (1.8% versus 0%, RR 8.17, 95% CI 0.45 - 147.77). This finding should be interpreted with caution. The three deaths occurred in the breast stimulation arm of a three-armed trial (breast stimulation versus no intervention versus oxytocin) of questionable quality. The study was very small (n = 57), involved only high risk women, and the method of randomisation was not reported. When comparing breast stimulation with oxytocin alone the analysis found no difference in caesarean section rates (28% versus 47%, RR 0.60, 95% CI 0.31 - 1.18). No difference was detected in the number of women not in labour after 72 hours (58.8% versus 25%, RR 2.35, 95% CI 1.00 - 5.54). There was no significant difference in the rates of meconium staining. There were four perinatal deaths. Three in the breast stimulation arm, and one in the oxytocin arm of the three-armed trial noted above (17.6% versus 5%, RR 3.53, 95% CI 0.40-30.88). REVIEWER'S CONCLUSIONS: Breast stimulation cannot be fully evaluated on efficacy and safety grounds from the included studies. Whilst it would appear beneficial in terms of a reduction in the number of women not in labour after 72 hours, and a reduction in postpartum haemorrhage, until safety issues have been fully evaluated it should not be considered for use in a high risk population.

Breast↗

PubMed2001

Oestrogens alone or with amniotomy for cervical ripening or induction of labour.

BACKGROUND: Studies in sheep showed that there is a pre-labour rise in oestrogen and a decrease in progesterone, both of these changes stimulate prostaglandin production and may help initiate labour. Though oestrogen has been suggested as an effective cervical ripening or induction agent, research in humans have failed to demonstrate a similar physiological mechanism. The use of oestrogen as an induction agent is not currently common practice, as such this systematic review should be regarded as an historical review. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology. OBJECTIVES: To determine, from the best available evidence, the effectiveness and safety of oestrogens alone or with amniotomy for third trimester cervical ripening and induction of labour in comparison with other methods of induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: April 2001. SELECTION CRITERIA: (1) randomised controlled trials comparing oestrogens alone used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A generic strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally. MAIN RESULTS: When comparing oestrogen with placebo there was no difference between the rate of caesarean section (7.1% versus 10.3%, relative risk (RR) 0.70, 95% confidence interval (CI) 0.30,1.62). There were no differences between rates of uterine hyperstimulation with or without fetal heart rate changes or instrumental vaginal delivery. None of the studies reported the rates of either vaginal delivery not achieved in 24 hours, or cervix unfavourable/unchanged after 12-24 hours. There were insufficient data to make any meaningful conclusions when comparing oestrogen with vaginal PGE2, intracervical PGE2, oxytocin alone or extra amniotic PGF2a, as to whether oestrogen is effective in inducing labour. REVIEWER'S CONCLUSIONS: There were insufficient data to draw any conclusions regarding the efficacy of oestrogen as an induction agent.

Amnion↗

PubMed2003

Heparin for pregnant women with acquired or inherited thrombophilias.

BACKGROUND: Thrombophilias, which are associated with a predisposition to thrombotic events, have been implicated in adverse obstetrical outcomes such as intrauterine growth restriction, stillbirth, severe early onset pre-eclampsia, and placental abruption. Heparin administration in pregnancy may reduce the risk of these events. OBJECTIVES: The objective of this review was to assess the effects of heparin on pregnancy outcomes for women with a thrombophilia. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (July 2002), MEDLINE, EMBASE, CINAHL, Scidex (via OVID Technologies - July 2002) and reference lists and personal files. SELECTION CRITERIA: Randomized controlled trials comparing heparin with placebo or no treatment, or randomized controlled trials comparing any two treatments. Quasi randomized studies would be included. DATA COLLECTION AND ANALYSIS: Data would be abstracted from identified studies and recorded on a paper form by two reviewers. MAIN RESULTS: No studies were included. REVIEWER'S CONCLUSIONS: There are no completed trials to determine the effects of heparin on pregnancy outcomes for women with a thrombophilia.

Anticoagulants↗