M Boulvain1, A Kelly, C Lohse, C Stan, O Irion. 1. Unité de Développement en Obstétrique, Maternité Hôpitaux Universitaires de Genève, Département de Gynécologie et d'Obstétrique, Boulevard de la Cluse, 32, Geneva 14, Switzerland, CH-1211. michel.boulvain@hcuge.ch
Abstract
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.
RCT Entities:
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.