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PubMed1975

Randomised clinical trial of strategies for improving medication compliance in primary hypertension.

230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine.

Antihypertensive Agents↗

PubMedDate not supplied

Improving searching skills and evidence retrieval.

OBJECTIVE: To evaluate the effect of a three-hour training session in formulating questions and searching databases. DESIGN: A randomised controlled trial and before and after study, with blinded outcome assessment. SETTING: Oxford University Medical School, first clinical year. SUBJECTS: Altogether 108 medical students were randomly assigned to an experimental group (54) or a control group (54), and all were given the task of searching for evidence around an ulcer related problem or a cardiac problem. Students in the experimental group were randomly allocated to research one of the two problems before training and the remaining problem afterwards. Control students received no training and were randomly allocated to search for evidence around either of these problems. MAIN OUTCOME MEASURES: Searching performance; the quality of evidence retrieved; student satisfaction. RESULTS: Training improved the students' search performance and the quality of evidence retrieved. Students' satisfaction with the training was high. CONCLUSIONS: A three-hour interactive training session improved the students' ability to search databases and retrieve evidence and was well received by the students.

Adult↗

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↗

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↗

PubMed1998

A controlled trial of lambda-cyhalothrin-impregnated bed nets and/or dapsone/pyrimethamine for malaria control in Sierra Leone.

A randomized controlled trial investigated the impact of community-wide use of mosquito nets impregnated with lambda-cyhalothrin alone or with dapsone/pyrimethamine (d/p) prophylaxis on clinical malaria due to perennially transmitted Plasmodium falciparum in children in the Bo district of Sierra Leone. The 17 study communities were pair-matched and randomly allocated to receive treated mosquito nets or no nets and the children (age range = 3 months-6 years) in each community were randomly allocated to receive d/p or placebo individually every two weeks. This resulted in each of the approximately 2,000 children recruited being in one of four study groups (impregnated mosquito nets and d/p prophylaxis, impregnated mosquito nets, d/p prophylaxis, and controls). The intervention phase of the study lasted 12 months. A total of 1,800 children attended more than 25% of the 48 total weekly morbidity surveillance surveys and were included in the analysis. The effects of the exclusive use of either treated mosquito nets or d/p prophylaxis on protection against clinical malaria due to P. falciparum was significantly similar (49% and 42%, respectively), while in combination this protective efficacy was significantly increased to 72% (95% confidence interval = 67-76%). Children in the control group had an average of 1.3 clinical malaria episodes per child annually compared with 0.65 episodes or 0.78 episodes for those using treated mosquito nets and d/p, respectively. Children using both treated mosquito nets and d/p prophylaxis had an average of 0.37 episodes per child. The interventions significantly reduced spleen rates and increased hematocrit values, and reduced the duration of episodes of clinical malaria.

Anti-Infective Agents↗

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↗

PubMed2000

Amniotomy alone for induction of labour.

BACKGROUND: Amniotomy (deliberate rupture of the membranes) is a simple procedure which can be used alone for induction of labour if the membranes are accessible, thus avoiding the need for pharmacological intervention. However, the time interval from amniotomy to established labour may not be acceptable to clinicians and women, and in a number of cases labour may not ensue. 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 amniotomy alone for third trimester labour induction in women with a live fetus. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled trials register and bibliographies of relevant papers. SELECTION CRITERIA: The criteria for inclusion included the following: (1) clinical trials comparing amniotomy alone 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 or pseudo-random allocation to the treatment or control group; (3) ideally 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: This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. 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 the series of primary reviews arranged by methods of induction of labour. The data from the primary reviews will be incorporated into a series of secondary reviews, arranged by category of woman to reflect clinical scenarios. To avoid duplication of data in the primary reviews, the labour induction methods have been listed in a specific order, from one to 25. Each primary review includes comparisons between one of the methods (from two to 25) with only those methods above it on the list. This review includes comparisons between amniotomy alone (number 5 on the list) with only those methods above it on the list (no treatment / placebo; intravaginal prostaglandins; intracervical prostaglandins; and oxytocin alone). MAIN RESULTS: Two trials comprising 50 and 260 women respectively were eligible for inclusion in this review. No conclusions could be drawn from comparisons of amniotomy alone versus no intervention, and amniotomy alone versus oxytocin alone (small trial, only one pre-specified outcome reported). No trials compared amniotomy alone with intracervical prostaglandins. One trial compared amniotomy alone with a single dose of vaginal prostaglandins for women with a favourable cervix, and found a significant increase in the need for oxytocin augmentation in the amniotomy alone group (44% versus 15%; RR 2.85, 95% CI 1.82-4.46). This should be viewed with caution as this was the result of a single centre trial. Furthermore, secondary intervention occurred 4 hours after amniotomy, and this time interval may not have been appropriate. REVIEWER'S CONCLUSIONS: Data is lacking about the value of amniotomy alone for induction of labour. While there are now other modern methods available for induction of labour (pharmacological agents), there remain clinical scenarios where amniotomy alone may be desirable and appropriate, and this method is worthy of further research. This research should include evaluation of the appropriate time interval from amniotomy to secondary intervention, women and caregivers' satisfaction and economic analysis.

Amnion↗

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↗

PubMed2000

Intravenous prostaglandin for induction of labour.

BACKGROUND: Intravenous prostaglandin E2 and F2 alpha can be used to induce labour. The use of intravenous prostaglandins in this context has been limited by perceived unacceptable maternal side effect profiles. 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 intravenous 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. SELECTION CRITERIA: The criteria for inclusion included the following: (1) clinical trials comparing intravenous 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 involves a two-stage method of data extraction. The initial data extraction is done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data will then be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. To avoid duplication of data in the primary reviews, the labour induction methods have been listed in a specific order, from one to 25. Each primary review includes comparisons between one of the methods (from two to 25) with only those methods above it on the list. MAIN RESULTS: Thirteen trials were eligible for inclusion in this review. Two trials (comprising 400 women) compared intravenous prostaglandin E2 to intravenous oxytocin, a further seven trials (comprising 590 women) compared intravenous prostaglandin F2 alpha to intravenous oxytocin. Two trials (comprising 115 women) each randomised women to one of three treatment arms namely intravenous oxytocin or intravenous prostaglandin F2 alpha or prostaglandin E2. One trial reported a comparison of combined oxytocin and prostaglandin F2 alpha and oxytocin alone in 20 women and lastly one trial compared extra amniotic prostaglandin E2 versus intravenous prostaglandin E2 (40 women). The use of intravenous prostaglandin was associated with higher rates of uterine hyperstimulation with changes in the fetal heart rate (relative risk (RR) 6.76, 95% confidence interval (CI) 1.23-37.11) and without (RR 4.25, 95%CI 1.48-12.24) compared to oxytocin. Use of prostaglandins was also associated with significantly more maternal side effects (gastrointestinal, thrombophlebitis and pyrexia, RR 3.75, 95% CI 2.46-5.70) than oxytocin. Prostaglandin was no more likely to result in vaginal delivery than oxytocin (RR 0.85, 95% CI 0.61-1.18). No significant differences emerged from subgroup analysis or from the trials comparing combination oxytocin/prostaglandin F2 alpha and oxytocin or extra amniotic versus intravenous prostaglandin E2. REVIEWER'S CONCLUSIONS: Intravenous prostaglandin is no more efficient than intravenous oxytocin for the induction of labour but its use is associated with higher rates of maternal side effects and uterine hyperstimulation than oxytocin. No conclusions can be drawn form the comparisons of combination of prostaglandin F2 alpha and oxytocin compared to oxytocin alone or extra amniotic and intravenous prostaglandin E2.

Clinical Trials as Topic↗

PubMed2000

Mifepristone for induction of labour.

BACKGROUND: The steroid hormone, progesterone, inhibits contractions of the uterus. Antiprogestins (including mifepristone) have been developed to antagonise the action of progesterone, and these have a recognised role in medical termination of early or mid-pregnancy. Animal studies have suggested that mifepristone may also have a role in inducing labour in late pregnancy. OBJECTIVES: To determine the effects of mifepristone for third trimester cervical ripening or induction of labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register, and reference lists of relevant papers. SELECTION CRITERIA: Selection criteria included: (1) clinical trials comparing mifepristone used for third trimester cervical ripening or labour induction with placebo/no treatment or other 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: This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. Data were extracted by the reviewer and, independently, by a colleague. MAIN RESULTS: Seven trials, that recruited 594 women, are included. All trials compared mifepristone with placebo, except for one that compared mifepristone with no treatment. Compared to placebo, mifepristone treated women were less likely to have an unfavourable cervix at 48 hours (relative risk [RR] 0.36, 95% confidence intervals [CI] 0.2-0.63) or 96 hours (RR 0.39, 95% CI 0.23-0.66). Mifepristone treated women were more likely to have delivered within 48 and 96 hours of treatment than were placebo treated/no treatment women - 48 hours: RR 2.82, 95% CI 1.82-4.36; 96 hours: RR 3.40, 95% CI 1.96-5.92. Mifepristone treated women were less likely to undergo caesarean section (RR 0.71, 95% CI 0.53-0.95). There is little information about fetal outcome, although there was no evidence that neonatal hypoglycaemia might be more common after exposure to mifepristone. Similarly, there is little information about maternal side-effects although some nausea and vomiting was reported in one trial. REVIEWER'S CONCLUSIONS: There is insufficient information available from clinical trials to support the use of mifepristone to induce labour. However, available data do show that mifepristone is better than placebo at ripening the cervix, and inducing labour. There is evidence of a possible reduction in the incidence of caesarean section following mifepristone treatment (compared to placebo) that would justify further trials. We found no trials that compared mifepristone with alternative methods of inducing labour e.g. prostaglandins.

Clinical Trials as Topic↗

PubMed2001

Acupuncture for induction of labour.

BACKGROUND: This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. The use of complementary therapies is rising and some women look to complementary therapies during pregnancy and childbirth to be used alongside conventional medical practice. Acupuncture involves the insertion of very fine needles into specific points of the body. The limited observational studies to date suggest acupuncture for induction of labour appears safe, has no known teratogenic effects, and may be effective. The evidence regarding the clinical effectiveness of this technique is limited. OBJECTIVES: To determine the effects of acupuncture 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. SELECTION CRITERIA: The criteria for inclusion included the following: (1) clinical trials comparing acupuncture 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. The initial data extraction is done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data will then be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. To avoid duplication of data in the primary reviews, the labour induction methods have been listed in a specific order, from one to 25. Each primary review includes comparisons between one of the methods (from two to 25) with only those methods above it on the list. MAIN RESULTS: No trials met the inclusion criteria for the systematic review. REVIEWER'S CONCLUSIONS: There is a need for a well designed randomised controlled trial to evaluate the role of acupuncture to induce labour.

Acupuncture↗

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

Oral prostaglandin E2 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 oral prostaglandin E2 for third trimester 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: The criteria for inclusion included the following: (1) clinical trials comparing oral prostaglandin E2 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. The initial data extraction is done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data will then be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. To avoid duplication of data in the primary reviews, the labour induction methods have been listed in a specific order, from one to 25. Each primary review includes comparisons between one of the methods (from two to 25) with only those methods above it on the list. MAIN RESULTS: There were 19 studies included in the review. Of these 15 included a comparison using either oral or intravenous oxytocin with or without amniotomy. The quality of studies reviewed was not high. Only seven studies had clearly described allocation concealment. Only two studies stated that providers and/or participants were blinded to treatment group. For the outcome of vaginal delivery not achieved within 24 hours, in the composite comparison of oral PGE2 versus all oxytocin treatments (oral and intravenous, with and without amniotomy), there was a trend favoring oxytocin treatments (relative risk (RR) 1.97, 95% confidence interval (CI) 0.86 to 4.48). For the outcome of cesarean section, in the comparison of PGE2 versus no treatment or placebo, PGE2 was favored (relative risk (RR) 0.54, 95% confidence interval (CI) 0.29,0.98). Otherwise, there were no significant differences between groups for this outcome. Oral prostaglandin was associated with vomiting across all comparison groups. REVIEWER'S CONCLUSIONS: Oral prostaglandin consistently resulted in more frequent gastrointestinal side effects, in particular vomiting, compared with the other treatments included in this review. There were no clear advantages to oral prostaglandin over other methods of induction of labour.

Administration, Oral↗

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

Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

BACKGROUND: Prostaglandins have been used for induction of labour since the 1960s. Initial work focused on prostaglandin F2a as prostaglandin E2 was considered unsuitable for a number of reasons. With the development of alternative routes of administration, comparisons were made between various formulations of vaginal prostaglandins. 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 vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except Misoprostol). 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: 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 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 was then extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. To avoid duplication of data in the primary reviews, the labour induction methods were listed in a specific order, from one to 23. Each primary review included comparisons between one of the methods (from two to 23) with only those methods above it on the list. MAIN RESULTS: In total, 94 studies were considered; 42 have been excluded and 52 included examining a total of 9402 women. Vaginal prostaglandin E2 compared with placebo or no treatment reduced the likelihood of vaginal delivery not being achieved within 24 hours (18% vs. 99%, RR 0.19, 95% CI 0.14,0.25), the caesarean section rates were not different between groups although the risk of uterine hyperstimulation with fetal heart rate changes was increased (4.6% vs. 0.51%, RR 4.14, 95% CI 1.93, 8.90). Comparison of vaginal prostaglandin F2a with placebo showed no increase in caesarean section rates but the cervical score was more likely to be improved (15% vs. 60%, RR 0.25, 95% CI 0.13,0.49), and the risk of oxytocin augmentation reduced (53.9% vs. 89.1%, RR 0.60, 95% CI 0.43,0.84) with the use of vaginal PGF2a. There were insufficient data to make meaningful conclusions for the comparison of vaginal PGE2 and PGF2a. PGE2 tablet, gel and pessary appear to be as efficacious as each other. Lower dose regimes, as defined in the review, appear as efficacious as higher dose regimes. REVIEWER'S CONCLUSIONS: The primary aim of this review was to examine the efficacy of vaginal prostaglandin E2 and F2a. This is reflected by an increase in successful vaginal delivery rates in 24 hours, no increase in operative delivery rates and significant improvements in cervical favourability within 24-48 hours. Further research is needed to quantify the cost-analysis of induction of labour with vaginal prostaglandins, with special attention to different methods of administration.

Administration, Intravaginal↗

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↗