Techniques for the interruption of tubal patency for female sterilisation.

BACKGROUND: This is an update of a review that was first published in 2002. Female sterilisation is the most popular contraceptive method worldwide. Several techniques exist for interrupting the patency of fallopian tubes, including cutting and tying the tubes, damaging the tube using electric current, applying clips or silicone rubber rings, and blocking the tubes with chemicals or tubal inserts. OBJECTIVES: To compare the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' satisfaction. SEARCH METHODS: For the original review published in 2002 we searched MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL). For this 2015 update, we searched POPLINE, LILACS, PubMed and CENTRAL on 23 July 2015. We used the related articles feature of PubMed and searched reference lists of newly identified trials. SELECTION CRITERIA: All randomized controlled trials (RCTs) comparing different techniques for tubal sterilisation, irrespective of the route of fallopian tube access or the method of anaesthesia. DATA COLLECTION AND ANALYSIS: For the original review, two review authors independently selected studies, extracted data and assessed risk of bias. For this update, data extraction was performed by one author (TL) and checked by another (RK). We grouped trials according to the type of comparison evaluated. Results are reported as odds ratios (OR) or mean differences (MD) using fixed-effect methods, unless heterogeneity was high, in which case we used random-effects methods. MAIN RESULTS: We included 19 RCTs involving 13,209 women. Most studies concerned interval sterilisation; three RCTs involving 1632 women, concerned postpartum sterilisation. Comparisons included tubal rings versus clips (six RCTs, 4232 women); partial salpingectomy versus electrocoagulation (three RCTs, 2019 women); tubal rings versus electrocoagulation (two RCTs, 599 women); partial salpingectomy versus clips (four RCTs, 3627 women); clips versus electrocoagulation (two RCTs, 206 women); and Hulka versus Filshie clips (two RCTs, 2326 women). RCTs of clips versus electrocoagulation contributed no data to the review.One year after sterilisation, failure rates were low (< 5/1000) for all methods.There were no deaths reported with any method, and major morbidity related to the occlusion technique was rare.Minor morbidity was higher with the tubal ring than the clip (Peto OR 2.15, 95% CI 1.22 to 3.78; participants = 842; studies = 2; I² = 0%; high-quality evidence), as were technical failures (Peto OR 3.93, 95% CI 2.43 to 6.35; participants = 3476; studies = 3; I² = 0%; high-quality evidence).Major morbidity was significantly higher with the modified Pomeroy technique than electrocoagulation (Peto OR 2.87, 95% CI 1.13 to 7.25; participants = 1905; studies = 2; I² = 0%; low-quality evidence), as was postoperative pain (Peto OR 3.85, 95% CI 2.91 to 5.10; participants = 1905; studies = 2; I² = 0%; moderate-quality evidence).When tubal rings were compared with electrocoagulation, postoperative pain was reported significantly more frequently for tubal rings (OR 3.40, 95% CI 1.17 to 9.84; participants = 596; studies = 2; I² = 87%; low-quality evidence).When partial salpingectomy was compared with clips, there were no major morbidity events in either group (participants = 2198, studies = 1). The frequency of minor morbidity was low and not significantly different between groups (Peto OR 7.39, 95% CI 0.46 to 119.01; participants = 193; studies = 1, low-quality evidence). Although technical failure occurred more frequently with clips (Peto OR 0.18, 95% CI 0.08 to 0.40; participants = 2198; studies = 1; moderate-quality evidence); operative time was shorter with clips than partial salpingectomy (MD 4.26 minutes, 95% CI 3.65 to 4.86; participants = 2223; studies = 2; I² = 0%; high-quality evidence).We found little evidence concerning women's or surgeon's satisfaction. No RCTs compared tubal microinserts (hysteroscopic sterilisation) or chemical inserts (quinacrine) to other methods. AUTHORS' CONCLUSIONS: Tubal sterilisation by partial salpingectomy, electrocoagulation, or using clips or rings, is a safe and effective method of contraception. Failure rates at 12 months post-sterilisation and major morbidity are rare outcomes with any of these techniques. Minor complications and technical failures appear to be more common with rings than clips. Electrocoagulation may be associated with less postoperative pain than the modified Pomeroy or tubal ring methods. Further research should include RCTs (for effectiveness) and controlled observational studies (for adverse effects) on sterilisation by minimally-invasive methods, i.e. tubal inserts and quinacrine.

Techniques for the interruption of tubal patency for female sterilisation.

BACKGROUND: This is an update of a review that was first published in 2002. Female sterilisation is the most popular contraceptive method worldwide. Several techniques exist for interrupting the patency of fallopian tubes, including cutting and tying the tubes, damaging the tube using electric current, applying clips or silicone rubber rings, and blocking the tubes with chemicals or tubal inserts. OBJECTIVES: To compare the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' satisfaction. SEARCH METHODS: For the original review published in 2002 we searched MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL). For this 2015 update, we searched POPLINE, LILACS, PubMed and CENTRAL on 23 July 2015. We used the related articles feature of PubMed and searched reference lists of newly identified trials. SELECTION CRITERIA: All randomized controlled trials (RCTs) comparing different techniques for tubal sterilisation, irrespective of the route of fallopian tube access or the method of anaesthesia. DATA COLLECTION AND ANALYSIS: For the original review, two review authors independently selected studies, extracted data and assessed risk of bias. For this update, data extraction was performed by one author (TL) and checked by another (RK). We grouped trials according to the type of comparison evaluated. Results are reported as odds ratios (OR) or mean differences (MD) using fixed-effect methods, unless heterogeneity was high, in which case we used random-effects methods. MAIN RESULTS: We included 19 RCTs involving 13,209 women. Most studies concerned interval sterilisation; three RCTs involving 1632 women, concerned postpartum sterilisation. Comparisons included tubal rings versus clips (six RCTs, 4232 women); partial salpingectomy versus electrocoagulation (three RCTs, 2019 women); tubal rings versus electrocoagulation (two RCTs, 599 women); partial salpingectomy versus clips (four RCTs, 3827 women); clips versus electrocoagulation (two RCTs, 206 women); and Hulka versus Filshie clips (two RCTs, 2326 women). RCTs of clips versus electrocoagulation contributed no data to the review.One year after sterilisation, failure rates were low (< 5/1000) for all methods.There were no deaths reported with any method, and major morbidity related to the occlusion technique was rare.Minor morbidity was statistically significantly higher with the tubal ring than the clip (Peto OR 2.15, 95% CI 1.22 to 3.78; participants = 842; studies = 2; I² = 0%; high-quality evidence), as were technical failures (Peto OR 3.93, 95% CI 2.43 to 6.35; participants = 3476; studies = 3; I² = 0%; high-quality evidence).Major morbidity was significantly higher with the modified Pomeroy technique than electrocoagulation (Peto OR 2.87, 95% CI 1.13 to 7.25; participants = 1905; studies = 2; I² = 0%; low-quality evidence), as was postoperative pain (Peto OR 3.85, 95% CI 2.91 to 5.10; participants = 1905; studies = 2; I² = 0%; moderate-quality evidence).When tubal rings were compared with electrocoagulation, postoperative pain was reported significantly more frequently for tubal rings (OR 3.40, 95% CI 1.17 to 9.84; participants = 596; studies = 2; I² = 87%; low-quality evidence).When partial salpingectomy was compared with clips, there were no major morbidity events in either group (participants = 2198, studies = 1). The frequency of minor morbidity was low and not significantly different between groups (Peto OR 7.39, 95% CI 0.46 to 119.01; participants = 193; studies = 1, low-quality evidence). Although technical failure occurred more frequently with clips (Peto OR 0.18, 95% CI 0.08 to 0.40; participants = 2198; studies = 1; moderate-quality evidence); operative time was shorter with clips than partial salpingectomy (MD 4.26 minutes, 95% CI 3.65 to 4.86; participants = 2223; studies = 2; I² = 0%; high-quality evidence).We found little evidence concerning women's or surgeon's satisfaction. No RCTs compared tubal microinserts (hysteroscopic sterilisation) or chemical inserts (quinacrine) to other methods. AUTHORS' CONCLUSIONS: Tubal sterilisation by partial salpingectomy, electrocoagulation, or using clips or rings, is a safe and effective method of contraception. Failure rates at 12 months post-sterilisation and major morbidity are rare outcomes with any of these techniques. Minor complications and technical failures may be more common with rings than clips. Electrocoagulation may be associated with less postoperative pain than the modified Pomeroy or tubal ring methods. Further research should include RCTs (for effectiveness) and controlled observational studies (for adverse effects) on sterilisation by minimally-invasive methods, i.e. tubal inserts and quinacrine.

Expedited versus conservative approaches for vaginal delivery in breech presentation.

BACKGROUND: In a vaginal breech birth there may be benefit from rapid delivery of the baby to prevent progressive acidosis. However, this needs to be weighed against the potential trauma of a quick delivery. OBJECTIVES: The objective of this review was to assess the effects of expedited vaginal delivery (breech delivery from umbilicus to delivery of the head within one contraction) on perinatal outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of expedited vaginal breech delivery compared with delivery not routinely expedited in women undergoing vaginal breech delivery. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the one identified trial for inclusion.If studies are included in future updates, two review authors will assess risk of bias, extract data and check data for accuracy. MAIN RESULTS: No studies were included. AUTHORS' CONCLUSIONS: There is not enough evidence to evaluate the effects of expedited vaginal breech delivery.

External cephalic version for breech presentation at term.

BACKGROUND: Management of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure. OBJECTIVES: The objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Trials Register (28 February 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation. DATA COLLECTION AND ANALYSIS: Two review authors assessed eligibility and trial quality, and extracted the data. MAIN RESULTS: We included eight studies, with a total of 1308 women randomised. The pooled data from these studies show a statistically significant and clinically meaningful reduction in non-cephalic presentation at birth (average risk ratio (RR) 0.42, 95% confidence interval (CI) 0.29 to 0.61, eight trials, 1305 women); vaginal cephalic birth not achieved (average RR 0.46, 95% CI 0.33 to 0.62, seven trials, 1253 women, evidence graded very low); and caesarean section (average RR 0.57, 95% CI 0.40 to 0.82, eight trials, 1305 women, evidence graded very low) when ECV was attempted in comparison to no ECV attempted. There were no significant differences in the incidence of Apgar score ratings below seven at one minute (average RR 0.67, 95% CI 0.32 to 1.37, three trials, 168 infants) or five minutes (RR 0.63, 95% CI 0.29 to 1.36, five trials, 428 infants, evidence graded very low), low umbilical vein pH levels (RR 0.65, 95% CI 0.17 to 2.44, one trial, 52 infants, evidence graded very low), neonatal admission (RR 0.80, 95% CI 0.48 to 1.34, four trials, 368 infants, evidence graded very low), perinatal death (RR 0.39, 95% CI 0.09 to 1.64, eight trials, 1305 infants, evidence graded low), nor time from enrolment to delivery (mean difference -0.25 days, 95% CI -2.81 to 2.31, two trials, 256 women).All of the trials included in this review had design limitations, and the level of evidence was graded low or very low. No studies attempted to blind the intervention, and the process of random allocation was suboptimal in several studies. Three of the eight trials had serious design limitations, however excluding these studies in a sensitivity analysis for outcomes with substantial heterogeneity did not alter the results. AUTHORS' CONCLUSIONS: Attempting cephalic version at term reduces the chance of non-cephalic presentation at birth, vaginal cephalic birth not achieved and caesarean section. There is not enough evidence from randomised trials to assess complications of ECV at term. Large observational studies suggest that complications are rare.

WHO guideline for brief sexuality-related communication: implications for STI/HIV policy and practice.

Brief sexuality-related communication (BSC) aims to identify current and potential sexual concerns and motivate those at risk to change their sexual behaviour or maintain safe sexual behaviour. BSC in primary health care can range from 5 to 60 minutes and takes into account biological, psychological and social dimensions of sexual health and wellbeing. It focuses on opportunistic rather than systematic or continuous communication and can be used in conjunction with already established prevention programs. The informational and motivational techniques of BSC enable health care providers to communicate more effectively with their patients, encouraging them to take steps to avoid HIV and sexually transmitted infections. The WHO Department of Reproductive Health and Research, following a review and assessment of existing evidence with regards to BSC, has recently published the guideline on Brief Sexuality-Related Communication: Recommendations for a Public Health Approach.

Measurement of perceptions of educational environment in evidence-based medicine.

In recent years, there has been a renewed interest in measuring perceptions regarding different aspects of the medical educational environment. A reliable tool was developed for measuring perceptions of the educational environment as it relates to evidence-based medicine as part of a multicountry randomised controlled trial to evaluate the effectiveness of a clinically integrated evidence-based medicine course. Participants from 10 specialties completed the questionnaire. A working dataset of 518 observations was available. Two independent subsets of data were created for conducting an exploratory factor analysis (n=244) and a confirmatory factor analysis (n=274), respectively. The exploratory factor analysis yielded five 67-item definitive instruments, with five to nine dimensions; all resulted in acceptable explanations of the total variance (range 56.6-65.9%). In the confirmatory factor analysis phase, all goodness of-fit measures were acceptable for all models (root mean square error of approximation ≤ 0.047; comparative fit index ≥ 0.980; normed χ(2) ≤ 1.647; Bentler-Bonett normed fit index ≥ 0.951). The authors selected the factorisation with seven dimensions (factor-7 instrument) as the most useful on pragmatic grounds and named it Evidence-Based Medicine Educational Environment Measure 67 (EBMEEM-67). Cronbach's α for subscales ranged between 0.81 and 0.93. The subscales are: 'Knowledge and learning materials'; 'Learner support'; 'General relationships and support'; 'Institutional focus on EBM'; 'Education, training and supervision'; 'EBM application opportunities'; and 'Affirmation of EBM environment'. The EBMEEM-67 can be a useful diagnostic and benchmarking tool for evaluating the perceptions of residents of the environment in which evidence-based medicine education takes place.

Effectiveness of a clinically integrated e-learning course in evidence-based medicine for reproductive health training: a randomized trial.

CONTEXT: For evidence-based practice to embed culturally in the workplace, teaching of evidence-based medicine (EBM) should be clinically integrated. In low-middle-income countries (LMICs) there is a scarcity of EBM-trained clinical tutors, lack of protected time for teaching EBM, and poor access to relevant databases in languages other than English. OBJECTIVE: To evaluate the effects of a clinically integrated e-learning EBM course incorporating the World Health Organization (WHO) Reproductive Health Library (RHL) on knowledge, skills, and educational environment compared with traditional EBM teaching. DESIGN, SETTING, AND PARTICIPANTS: International cluster randomized trial conducted between April 2009 and November 2010 among postgraduate trainees in obstetrics-gynecology in 7 LMICs (Argentina, Brazil, Democratic Republic of the Congo, India, Philippines, South Africa, Thailand). Each training unit was randomized to an experimental clinically integrated course consisting of e-modules using the RHL for learning activities and trainee assessments (31 clusters, 123 participants) or to a control self-directed EBM course incorporating the RHL (29 clusters, 81 participants). A facilitator with EBM teaching experience was available at all teaching units. Courses were administered for 8 weeks, with assessments at baseline and 4 weeks after course completion. The study was completed in 24 experimental clusters (98 participants) and 22 control clusters (68 participants). MAIN OUTCOME MEASURES: Primary outcomes were change in EBM knowledge (score range, 0-62) and skills (score range, 0-14). Secondary outcome was educational environment (5-point Likert scale anchored between 1 [strongly agree] and 5 [strongly disagree]). RESULTS: At baseline, the study groups were similar in age, year of training, and EBM-related attitudes and knowledge. After the trial, the experimental group had higher mean scores in knowledge (38.1 [95% CI, 36.7 to 39.4] in the control group vs 43.1 [95% CI, 42.0 to 44.1] in the experimental group; adjusted difference, 4.9 [95% CI, 2.9 to 6.8]; P < .001) and skills (8.3 [95% CI, 7.9 to 8.7] vs 9.1 [95% CI, 8.7 to 9.4]; adjusted difference, 0.7 [95% CI, 0.1 to 1.3]; P = .02). Although there was no difference in improvement for the overall score for educational environment (6.0 [95% CI, -0.1 to 12.0] vs 13.6 [95% CI, 8.0 to 19.2]; adjusted difference, 9.6 [95% CI, -6.8 to 26.1]; P = .25), there was an associated mean improvement in the domains of general relationships and support (-0.5 [95% CI, -1.5 to 0.4] vs 0.3 [95% CI, -0.6 to 1.1]; adjusted difference, 2.3 [95% CI, 0.2 to 4.3]; P = .03) and EBM application opportunities (0.5 [95% CI, -0.7 to 1.8] vs 2.9 [95%, CI, 1.8 to 4.1]; adjusted difference, 3.3 [95% CI, 0.1 to 6.5]; P = .04). CONCLUSION: In a group of LMICs, a clinically integrated e-learning EBM curriculum in reproductive health compared with a self-directed EBM course resulted in higher knowledge and skill scores and improved educational environment. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12609000198224.

Cephalic version by postural management for breech presentation.

BACKGROUND: Babies with breech presentation (bottom first) are at increased risk of complications during birth, and are often delivered by caesarean section. The chance of breech presentation persisting at the time of delivery, and the risk of caesarean section, can be reduced by external cephalic version (ECV - turning the baby by manual manipulation through the mother's abdomen). It is also possible that maternal posture may influence fetal position. Many postural techniques have been used to promote cephalic version. OBJECTIVES: The objective of this review was to assess the effects of postural management of breech presentation on measures of pregnancy outcome. We evaluated procedures in which the mother rests with her pelvis elevated. These include the knee-chest position, and a supine position with the pelvis elevated with a wedge-shaped cushion. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (22 August 2012). SELECTION CRITERIA: Randomised and quasi-randomised trials comparing postural management with pelvic elevation for breech presentation, with a control group. DATA COLLECTION AND ANALYSIS: One or both review authors assessed eligibility and trial quality. MAIN RESULTS: We have included six studies involving a total of 417 women. The rates for non-cephalic births, Cesarean section and Apgar scores below 7 at one minute, regardless of whether ECV was attempted or not, were similar between the intervention and control groups (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.84 to 1.15; RR 1.10; 95% CI 0.89 to 1.37; RR 0.88; 95% CI 0.50 to 1.55). AUTHORS' CONCLUSIONS: There is insufficient evidence from well-controlled trials to support the use of postural management for breech presentation. The numbers of women studied to date remain relatively small. Further research is needed.

External cephalic version for breech presentation at term.

BACKGROUND: Management of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure. OBJECTIVES: The objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Trials Register (7 August 2012). SELECTION CRITERIA: Randomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation. DATA COLLECTION AND ANALYSIS: Two review authors assessed eligibility and trial quality, and extracted the data. MAIN RESULTS: We included seven studies. The pooled data from these studies show a statistically significant and clinically meaningful reduction in non-cephalic birth (seven trials, 1245 women; risk ratio (RR) 0.46, 95% confidence interval (CI) 0.31 to 0.66; and caesarean section (seven trials, 1245 women; RR 0.63, 95% CI 0.44 to 0.90) when ECV was attempted. There were no significant differences in the incidence of Apgar score ratings below seven at one minute (two trials, 108 women; RR 0.95, 95% CI 0.47 to 1.89) or five minutes (four trials, 368 women; RR 0.76, 95% CI 0.32 to 1.77), low umbilical artery pH levels (one trial, 52 women; RR 0.65, 95% CI 0.17 to 2.44), neonatal admission (one trial, 52 women; RR 0.36, 95% CI 0.04 to 3.24), perinatal death (six trials, 1053 women; RR 0.34, 95% CI 0.05 to 2.12), nor time from enrolment to delivery (2 trials, 256 women; weighted mean difference -0.25 days, 95% CI -2.81 to 2.31). AUTHORS' CONCLUSIONS: Attempting cephalic version at term reduces the chance of non-cephalic births and caesarean section. There is not enough evidence from randomised trials to assess complications of external cephalic version at term. Large observational studies suggest that complications are rare.

Expedited versus conservative approaches for vaginal delivery in breech presentation.

BACKGROUND: In a vaginal breech birth there may be benefit from rapid delivery of the baby to prevent progressive acidosis. However, this needs to be weighed against the potential trauma of a quick delivery. OBJECTIVES: The objective of this review was to assess the effects of expedited vaginal delivery (breech delivery from umbilicus to delivery of the head within one contraction) on perinatal outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 February 2012). SELECTION CRITERIA: Randomised trials of expedited vaginal breech delivery compared with delivery not routinely expedited in women undergoing vaginal breech delivery. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed by one reviewer. MAIN RESULTS: No studies were included. AUTHORS' CONCLUSIONS: There is not enough evidence to evaluate the effects of expedited vaginal breech delivery.

Abdominal decompression in normal pregnancy.

BACKGROUND: Abdominal decompression was developed as a means of pain relief during labour. It has also been used for complications of pregnancy, and in healthy pregnant women in an attempt to improve fetal wellbeing and intellectual development. OBJECTIVES: The objective of this review was to assess the effects of prophylactic abdominal decompression on pregnancy outcomes such as admission for pre-eclampsia, fetal growth, perinatal morbidity and mortality and childhood development. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 February 2012). SELECTION CRITERIA: Randomised trials comparing abdominal decompression with dummy decompression or no treatment in healthy pregnant women. DATA COLLECTION AND ANALYSIS: Both review authors assessed eligibility and trial quality. MAIN RESULTS: Three studies were included. There was no difference between the abdominal decompression groups and the control groups for low birthweight (risk ratio (RR) 0.69, 95% confidence interval (CI) 0.27 to 1.77) and perinatal mortality (RR 2.47, 95% CI 0.77 to 7.92). There were no differences in admission for pre-eclampsia, Apgar score and childhood development. AUTHORS' CONCLUSIONS: There is no evidence to support the use of abdominal decompression in normal pregnancies. Future research should be directed towards the use of abdominal decompression during labour, and during complicated pregnancies.

Piracetam for fetal distress in labour.

BACKGROUND: Piracetam is thought to promote the metabolism of brain cells when they are hypoxic. It has been used to prevent adverse effects of fetal distress. OBJECTIVES: The objective of this review was to assess the effects of piracetam for suspected fetal distress in labour on method of delivery and perinatal morbidity. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 February 2012). SELECTION CRITERIA: Randomised trials of piracetam compared with placebo or no treatment for suspected fetal distress in labour. DATA COLLECTION AND ANALYSIS: Both review authors assessed eligibility and trial quality. MAIN RESULTS: One study of 96 women was included. Piracetam compared with placebo was associated with a trend to reduced need for caesarean section (risk ratio 0.57, 95% confidence interval 0.32 to 1.03). There were no statistically significant differences between the piracetam and placebo group for neonatal morbidity (measured by neonatal respiratory distress) or Apgar score. AUTHORS' CONCLUSIONS: There is not enough evidence to evaluate the use of piracetam for fetal distress in labour.

Operative versus conservative management for 'fetal distress' in labour.

BACKGROUND: Suspected fetal distress usually results in expedited delivery of a baby (often operatively). The potential harm to a mother and baby from operative delivery may not always be justified especially when fetal distress may be misdiagnosed. Even with a correct diagnosis it is not clear whether an operative or conservative approach is better. OBJECTIVES: The objective of this review was to assess the effects of operative management for fetal distress on maternal and perinatal morbidity. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 February 2012). SELECTION CRITERIA: Randomised trials of operative (caesarean section or expedited vaginal delivery) versus conservative management of suspected fetal distress. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done by both review authors. MAIN RESULTS: One study of 350 women was included. This trial was carried out in 1959. There was no difference in perinatal mortality (risk ratio 1.18, 95% confidence interval 0.56 to 2.48). AUTHORS' CONCLUSIONS: There have been no contemporary trials of operative versus conservative management of suspected fetal distress. In settings without modern obstetric facilities, a policy of operative delivery in the event of meconium-stained liquor or fetal heart rate changes has not been shown to reduce perinatal mortality.

Guidance for evidence-informed policies about health systems: rationale for and challenges of guidance development.

In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

Vitamin D supplementation for women during pregnancy.

BACKGROUND: Vitamin D deficiency or insufficiency is thought to be common among pregnant women. Vitamin D supplementation during pregnancy has been suggested as an intervention to protect against adverse gestational outcomes. OBJECTIVES: To examine whether supplements with vitamin D alone or in combination with calcium or other vitamins and minerals given to women during pregnancy can safely improve maternal and neonatal outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2011), the International Clinical Trials Registry Platform (ICTRP) (31 October 2011), the Networked Digital Library of Theses and Dissertations (28 October 2011) and also contacted relevant organisations (8 April 2011). SELECTION CRITERIA: Randomised and quasi-randomised trials with randomisation at either individual or cluster level, evaluating the effect of supplementation with vitamin D alone or in combination with other micronutrients for women during pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors independently i) assessed the eligibility of studies against the inclusion criteria ii) extracted data from included studies, and iii) assessed the risk of bias of the included studies. Data were checked for accuracy. MAIN RESULTS: The search strategy identified 34 potentially eligible references. We included six trials assessing a total of 1023 women, excluded eight studies, and 10 studies are still ongoing. Five trials involving 623 women compared the effects of vitamin D alone versus no supplementation/placebo and one trial with 400 women compared the effects of vitamin D and calcium versus no supplementation.Only one trial with 400 women reported on pre-eclampsia: women who received 1200 IU vitamin D along with 375 mg of elemental calcium per day were as likely to develop pre-eclampsia as women who received no supplementation (average risk ratio (RR) 0.67; 95% confidence interval (CI) 0.33 to 1.35). Data from four trials involving 414 women consistently show that women who received vitamin D supplements had higher concentrations of vitamin D in serum at term than those women who received no intervention or a placebo; however the magnitude of the response was highly heterogenous. Data from three trials involving 463 women suggest that women who receive vitamin D supplements during pregnancy less frequently had a baby with a birthweight below 2500 grams than those women receiving no treatment or placebo; statistical significance was borderline (RR 0.48; 95% CI 0.23 to 1.01).In terms of other conditions, there were no significant differences in adverse side effects including nephritic syndrome (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women); stillbirths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) or neonatal deaths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) between women who received vitamin D supplements in comparison with women who received no treatment or placebo. No studies reported on preterm birth, maternal death, admission to neonatal intensive care unit/special nursery or Apgar scores. AUTHORS' CONCLUSIONS: Vitamin D supplementation in a single or continued dose during pregnancy increases serum vitamin D concentrations as measured by 25-hydroxyvitamin D at term. The clinical significance of this finding and the potential use of this intervention as a part of routine antenatal care are yet to be determined as the number of high quality trials and outcomes reported is too limited to draw conclusions on its usefulness and safety. Further rigorous randomised trials are required to evaluate the role of vitamin D supplementation in pregnancy.

Medical methods for first trimester abortion.

BACKGROUND: Surgical abortion by vacuum aspiration or dilatation and curettage has been the method of choice for early pregnancy termination since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins. OBJECTIVES: To compare different medical methods for first trimester abortion. SEARCH METHODS: The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted. SELECTION CRITERIA: Types of studies Randomised controlled trials comparing different medical methods for abortion during first trimester (e.g. single drug, combination) were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant during the first trimester, undergoing medical abortion were the participants. The outcomes were mortality, failure to achieve complete abortion, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the procedure. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion from the results of the search strategy described previously.The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. Data were processed using Revman software. MAIN RESULTS: Fifty-eight trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. Sublingual and buccal routes were similarly effective compared to the vaginal route, but had higher rates of side effects. 2) Mifepristone alone is less effective when compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Five trials compared prostaglandin alone to the combined regimen (mifepristone/prostaglandin). All but one reported higher effectiveness with the combined regimen. The results of these studies could not be combined but the RR of failure with prostaglandin alone is reportedly between 1.4 to 3.75 with the 95% confidence intervals indicating statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference in effectiveness with use of a divided dose compared to a single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin demonstrates similar rates of failure to complete abortion when comparing intramuscular to oral methotrexate administration (RR 2.04, 95% CI 0.51 to 8.07). Similarly, day 3 vs. day 5 administration of prostaglandin following methotrexate administration showed no significant differences (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs. methotrexate and no statistically significant differences were observed in effectiveness between the groups. AUTHORS' CONCLUSIONS: Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Vaginal misoprostol is more effective than oral administration, and has less side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all trials were conducted in settings with good access to emergency services, which may limit the generalizability of these results.

Types of progestogens in combined oral contraception: effectiveness and side-effects.

BACKGROUND: The progestogen component of combined oral contraceptives (COC) has undergone changes since it was first recognised that it's chemical structure could influence the spectrum of minor adverse and beneficial effects. The major determinants of effectiveness are compliance and continuation which may be influenced by cycle control and common side effects. The rationale of this review is to provide a systematic comparison of COCs containing the progestogens currently in use worldwide. OBJECTIVES: To compare currently available low-dose COCs containing ethinyl estradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates. SEARCH STRATEGY: A search of PubMed, LILACS, EMBASE, Popline, CINAHL and the Cochrane Central Register of Controlled Trials databases was conducted in September 2010 to update the 2004 review. SELECTION CRITERIA: Randomised trials reporting clinical outcomes were considered for inclusion. We excluded studies comparing monophasic with multiphasic pills, crossover trials, trials in which the difference in total content of ethinyl estradiol between preparations exceeded 105 µg per cycle and those comparing continuous dosing regimens. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality, applied inclusion criteria and extracted data. MAIN RESULTS: Thirty trials with a total of 13,923 participants were included, generating 16 comparisons. Overall the quality of trials was low. Only four trials were double-blind. At least twenty-three trials were sponsored by pharmaceutical companies. There was less discontinuation with second-generation compared with first-generation monophasic progestogens (3 trials, 2,709 women, Relative Risk (RR) 0.76, 95% Confidence Interval (CI) 0.67-0.86); this remained significant when only double-blind trials were considered (812 women, RR 0.79, 95% CI 0.66-0.94).Women using monophasic COC's containing third-generation progestogens were less likely to discontinue than the second-generation group (3 trials, 1,815 women, RR 0.77, 95% CI 0.60-0.98) but this was not significant when only double-blind trials were considered (RR 0.79, 95% CI 0.50-1.26]. Women in the third-generation group experienced less intermenstrual bleeding than the second-generation group (one double-blind trial, 456 women, RR 0.71, 95% CI 0.55-0.91).Compared to desogestrel (DSG), women in the drospirenone (DRSP) group were more likely to complain of breast tenderness (5 trials, 4,258 women, RR 1.39, 95% CI 1.04-1.86) and nausea (6 trials, 4,701 women, RR 1.46, 95% CI 0.96-2.21].Pregnancy rates overall were comparable but the trials had insufficient power to find potentially important differences. AUTHORS' CONCLUSIONS: Women using COCs containing second-generation progestogens may be less likely to discontinue than those using COCs containing first-generation progestogens. Based on one small double-blind trial, third-generation progestogens may be preferable to second-generation preparations with regard to bleeding patterns but further evidence is needed. Without blinding as to treatment group, comparisons between the various "generations" of progestogens used in COCs cannot be made. Until this widespread methodological flaw is overcome in better trials conducted according to CONSORT guidelines and internationally accepted definitions, no further conclusions can be drawn.

Techniques for the interruption of tubal patency for female sterilisation.

BACKGROUND: Female sterilisation is the most popular contraceptive method worldwide. Several techniques are described in the literature, however only few of them are commonly used and properly evaluated. OBJECTIVES: To compare the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' views. SEARCH STRATEGY: Originally MEDLINE and The Cochrane Controlled Trials Register were searched. For the 2010 update, searches of Popline, Lilacs, Pubmed and The Cochrane Controlled Trials Register were performed. Reference lists of identified trials were searched. SELECTION CRITERIA: All randomised controlled trials comparing different techniques for tubal sterilisation, regardless of the route of Fallopian tube access or the method of anaesthesia. DATA COLLECTION AND ANALYSIS: Trials under consideration were evaluated for methodological quality and appropriateness for inclusion. Nine relevant studies were included and the results were stratified in five groups: tubal ring versus clip, modified Pomeroy versus electrocoagulation, tubal ring versus electrocoagulation, modified Pomeroy versus Filshie clip and Hulka versus Filshie clip. Results are reported as odds ratio for dichotomous outcomes and weighted mean differences for continuous outcomes. MAIN RESULTS: Tubal ring versus clip: Minor morbidity was higher in the ring group (Peto OR 2.15; 95% CI 1.22, 3.78). Technical difficulties were found less frequent in the clip group ( Peto OR 3.87; 95% CI 1.90, 7.89). There was no difference in failure rates between the two groups (Peto OR 0.70; 95% CI 0.28, 1.76). Pomeroy versus electrocoagulation: Women undergoing modified Pomeroy technique had higher major morbidity than those with the electrocoagulation technique (Peto OR 2.87; 95% CI 1.13, 7.25). Postoperative pain was more frequent in the Pomeroy group (Peto OR 3.85; 95% CI 2.91, 5.10). Tubal ring versus electrocoagulation: Post operative pain was more frequently reported in the tubal ring group. No pregnancies were reported. Pomeroy versus Filshie clip: In the only trial comparing the two interventions only one pregnancy was reported in the Pomeroy group after follow-up for 24 months. No differences were found when comparing Hulka versus Filshie clip in the only study that compared these two devices. AUTHORS' CONCLUSIONS: Electrocoagulation was associated with less morbidity including post-operative pain when compared with the modified Pomeroy and tubal ring methods, despite the risk of burns to the small bowel. The small sample size and the relative short period of follow-up in these studies limited the power to show clinical or statistical differences for rare outcomes such as failure rates. Aspects such as training, costs and maintenance of the equipment may be important factors in deciding which method to choose.

Comprehensive analysis of the use of pre-procedure ultrasound for first- and second-trimester abortion.

BACKGROUND: The use of ultrasound (US) is common in some settings before an abortion procedure. However, its positive effect on the safety or efficacy (ability to complete abortion) of the procedure has not been established. Our aim was to determine whether the use of pre-procedure US improves safety and/or efficacy of the abortion procedure. METHODS: We searched the following databases: Pubmed, Embase, Lilacs and Popline; reference lists of retrieved papers; and Google. We considered any controlled trial comparing women seeking abortion who received pre-procedure US to those who did not. Our outcome measures were efficacy of the abortion, complication rates and side effects. RESULTS: We did not identify any controlled trials or systematic reviews comparing the use of pre-procedure US to no US prior to abortion. CONCLUSIONS: Ultrasound is widely used in pregnancy to estimate gestational age and to detect any abnormalities of the pregnancy or uterus. The effect of its use among women undergoing abortion is unclear, and only indirect evidence is available.

WITHDRAWN: Vitamin A supplementation during pregnancy.

BACKGROUND: Vitamin A supplements have been recommended in pregnancy to improve outcomes that include maternal mortality and morbidity. OBJECTIVES: To review the effectiveness of vitamin A supplementation during pregnancy, alone or in combination with other supplements, on maternal and newborn clinical and laboratory outcomes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's specialised register of controlled trials (April 2002) and the Cochrane Controlled Trials Register (The Cochrane Library Issue 1, 2002). SELECTION CRITERIA: All randomised or quasi-randomised trials evaluating the effect of vitamin A supplementation in pregnant women. The types of intervention included vitamin A supplementation alone or in combination with other micro-nutrients. DATA COLLECTION AND ANALYSIS: We assessed trials for methodological quality using the standard Cochrane criteria of adequacy of concealment. At least two review authors independently assessed the trials for inclusion and extracted data. We collected information on blinding, loss to follow-up, setting, number of women, exclusion after randomisation and follow-up as well as supplementation type, dose and frequency. The outcomes we sought included maternal and neonatal clinical and laboratory outcomes. MAIN RESULTS: Five trials involving 23,426 women were included. Because the trials were heterogeneous with regard to type of supplement given, duration of supplement use and outcomes measured, pooled results using meta analysis could not be performed. One large population based trial in Nepal showed a possible beneficial effect on maternal mortality after weekly vitamin A supplements. In this study a reduction was noted in all cause maternal mortality up to 12 weeks postpartum with Vitamin A supplementation (RR 0.60, 95% CI 0.37-0.97). Night-blindness was assessed in a nested case-control study within this trial and found to be reduced but not eliminated. Three trials examined the effect of vitamin A supplementation on haemoglobin levels. The trial from Indonesia showed a beneficial effect in women who were anaemic ([Hb] <11.0 g/dl). After supplementation, the proportion of women who became non-anaemic was 35% in the Vitamin A supplemented group, 68% in the iron-supplemented group, 97% in the group supplemented with both Vitamin A and iron and 16% in the placebo group. The two trials from Malawi did not corroborate these positive findings. AUTHORS' CONCLUSIONS: Although the two trials from Nepal and Indonesia suggested beneficial effects of vitamin A supplementation, further trials are needed to determine whether vitamin A supplements can reduce maternal mortality and morbidity and by what mechanism.