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How to repair an anal sphincter injury after vaginal delivery: results of a randomised controlled trial.

OBJECTIVE: To compare two surgical techniques and two types of suture material for anal sphincter repair after childbirth-related injury. DESIGN: Factorial randomised controlled trial. SETTING: Tertiary referral maternity unit. POPULATION: Women with an anal sphincter injury sustained during childbirth. METHOD: Women were randomised into four groups: overlap repair with polyglactin (Vicryl); end-to-end repair with polyglactin (Vicryl); overlap repair with polydioxanone (PDS); and end-to-end repair with PDS. All repairs were completed as a primary procedure by staff trained in both methods. MAIN OUTCOME MEASURES: Suture-related morbidity at six weeks. Bowel symptoms at 3, 6 and 12 months. Anorectal physiology at three months. Quality of life scores at 3 and 12 months. RESULTS: One hundred and fifty women (1.5% of deliveries) were eligible and 112 (75%) were randomised. One hundred and three (92%) attended follow up visit at 6 weeks, 89 (80%) at 3 months, 79 (71%) at 6 months and 60 (54%) at 12 months. At six weeks, there was no difference in suture-related morbidity between groups (P=0.11) and 70% patients were completely asymptomatic. Incidence of bowel symptoms and quality of life disturbances were low, with no differences between the four groups. CONCLUSION: Obstetric anal sphincter repair carried out by appropriately trained staff is associated with low morbidity, irrespective of the suture material and repair method used.

Adult↗

Improving attendance for breast screening among recent non-attenders: a randomised controlled trial of two interventions in primary care.

OBJECTIVES: To examine the effectiveness and cost-effectiveness of two primary care based interventions aimed at increasing breast screening uptake for women who had recently failed to attend. SETTING: 13 General practices with low uptake in the second round of breast screening (below 60%) in north west London and the West Midlands, United Kingdom. Participants were women in these practices who were recent non-attenders for breast screening in the third round. METHODS: Pragmatic factorial randomised controlled trial, with people randomised to a systematic intervention (general practitioner letter), an opportunistic intervention (flag in women's notes prompting discussion by health professionals), neither intervention, or both. Outcome measures were attendance for screening 6 months after randomisation and cost-effectiveness of the interventions. RESULTS: 1,158 Women were individually randomised as follows: 289 control; 291 letter; 290 flag; 288 both interventions. Attendance was ascertained for 1,148 (99%) of the 1,158 women. Logistic regression adjusting for the other intervention and practice produced an odds ratio (OR) for attendance of 1.51 (95% confidence interval (95% CI 1.02 to 2.26; p=0.04) for the letter, and 1.39 (95% CI 0.93 to 2.07; p=0.10) for the flag. Health service costs/ additional attendance were 35 pounds (letter) and 65 pounds (flag). CONCLUSIONS: Among recent non-attenders, the letter was effective in increasing breast screening attendance. The flag was of equivocal effectiveness and was considerably less cost-effective than the letter.

Adult↗

Effect of pravastatin on frequency of fracture in the LIPID study: secondary analysis of a randomised controlled trial. Long-term Intervention with Pravastatin in Ischaemic Disease.

BACKGROUND: Statins inhibit the same biochemical pathway as aminobisphosphonates, therefore these cholesterol-lowering agents may have a beneficial effect on osteoporosis. This possibility has been supported by the finding that some statins also stimulate bone formation, and by observational studies suggesting that patients using statins have higher bone densities and lower fracture rates than controls. To assess whether statins have clinically significant effects on bone, we studied the frequency of fractures in a large randomised controlled trial of these agents. METHODS: 9014 patients (17% women, median age 62 years) with ischaemic heart disease were randomly assigned pravastatin 40 mg daily or placebo and followed up for a mean of 6.0 years. Fractures were ascertained from adverse-event reports. FINDINGS: 101 patients in the placebo group were admitted to hospital for fracture compared with 107 in the pravastatin group (hazard ratio 1.05 [95% CI 0.80-1.37]). When patients with fractures not necessitating hospital admission were added, the total number of patients having a fracture was 183 in the placebo group and 175 in the pravastatin group (0.94 [0.77-1.16]). Separate analyses for women alone and for individuals aged 65 years and over gave similar results. INTERPRETATION: These findings offer no support for the hypothesis that statins have a significant effect on fracture risk. However, this study was not of an osteoporotic population, and fracture rate, although clinically important, is an insensitive index of effects on bone. Statins should not be used to prevent osteoporosis until there is evidence for their efficacy based on randomised controlled trials.

Aged↗

Visibility aids for pedestrians and cyclists: a systematic review of randomised controlled trials.

This study aims to quantify the effect of visibility aids on the occurrence of pedestrian and cyclist-motor vehicle collisions and injuries, and drivers' responses in detection and recognition. Trial reports were systematically reviewed according to predefined eligibility criteria, including randomised controlled trials or controlled before-and-after trials comparing visibility aids and no visibility aids, and of different visibility aids on pedestrian and cyclist safety, and drivers' responses in detection and recognition. This included trials in which the order of interventions was randomised, or balanced using a Latin square design. Two reviewers independently assessed validity of trials and abstracted data. The main outcome measures were pedestrian and cyclist-motor vehicle collisions and injuries, and drivers'/observers' responses in the detection and recognition time, distance and frequency. No trials which assessed the effect of visibility aids on pedestrian and cyclist-motor vehicle collisions and injuries were identified. Twelve trials examined the effectiveness of daytime visibility aids and 25 trials on night time visibility aids, including 882 participants. Drivers' and observers' detection and recognition improved with visibility aids. For daytime, fluorescent materials in yellow, red and orange colours enhanced detection and recognition. "Biomotion" markings enhanced recognition. Substantial heterogeneity between the trials limits the possibility for meta-analysis. Visibility aids have the potential to improve detection and recognition and would merit further development to gain public acceptance. However, the impact of visibility aids on pedestrian and cyclist safety is unknown and needs to be determined.

Accidents, Traffic↗

Economic evaluation and randomised controlled trial of extracorporeal membrane oxygenation: UK collaborative trial. The Extracorporeal Membrane Oxygenation Economics Working Group.

OBJECTIVE: To compare the resource implications and short term outcomes of extracorporeal membrane oxygenation and conventional management for term babies with severe respiratory failure. DESIGN: Cost effectiveness evaluation alongside a randomised controlled trial. SETTING: 55 approved recruiting hospitals in the United Kingdom. These hospitals provided conventional management, but infants randomised to extracorporeal membrane oxygenation were transferred to one of five specialist centres. SUBJECTS: 185 mature newborn infants (gestational age at birth >35 weeks, birth weight >2 kg) with severe respiratory failure (oxygenation index >40) recruited between 1993 and 1995. The commonest diagnoses were persistent pulmonary hypertension due to meconium aspiration, congenital diaphragmatic hernia, isolated persistent fetal circulation, sepsis, and idiopathic respiratory distress syndrome. MAIN OUTCOME MEASURE: Cost effectiveness based on survival at 1 year of age without severe disability. RESULTS: 63 (68%) of the 93 infants randomised to extracorporeal membrane oxygenation survived to 1 year compared with 38 (41%) of the 92 infants who received conventional management. Of those that survived, one infant in each arm was lost to follow up and the proportion with disability at 1 year was similar in the two arms of the trial. One child in each arm had severe disability. The estimated additional cost of extracorporeal membrane oxygenation per additional surviving infant without severe disability was 51 222 pounds and the cost per surviving infant with no disability was 75 327 pounds. CONCLUSIONS: Extracorporeal membrane oxygenation for term neonates with severe respiratory failure would increase overall survival without disability. Although the policy will increase costs of neonatal health care, it is likely to be as cost effective as other life extending technologies.

Cost-Benefit Analysis↗

The Newcastle exercise project: a randomised controlled trial of methods to promote physical activity in primary care.

OBJECTIVE: To evaluate the effectiveness of combinations of three methods to promote physical activity. DESIGN: Randomised controlled trial. Baseline assessment with post-intervention follow up at 12 weeks and 1 year. SETTING: One urban general practice, 1995-7. PARTICIPANTS: 523 adults aged 40 to 64 years, randomised to four intervention groups and a control group. INTERVENTIONS: Brief (one interview) or intensive (six interviews over 12 weeks) motivational interviewing based on the stages of change model of behaviour change, with or without financial incentive (30 vouchers entitling free access to leisure facilities). MAIN OUTCOME MEASURES: Physical activity score; sessions of moderate and vigorous activity in the preceding four weeks. RESULTS: Response rate was 81% at 12 weeks and 85% at one year. More participants in the intervention group reported increased physical activity scores at 12 weeks than controls (38% v 16%, difference 22%, 95% confidence interval for difference 13% to 32%), with a 55% increase observed in those offered six interviews plus vouchers. Vigorous activity increased in 29% of intervention participants and 11% of controls (difference 18%, 10% to 26%), but differences between the intervention groups were not significant. Short term increases in activity were not sustained, regardless of intensity of intervention. CONCLUSIONS: The most effective intervention for promoting adoption of exercise was the most intensive. Even this did not promote long term adherence to exercise. Brief interventions promoting physical activity that are used by many schemes in the United Kingdom are of questionable effectiveness.

Adult↗

Nonclosure of the peritoneum during caesarean section: long-term follow-up of a randomised controlled trial.

OBJECTIVE: To compare long-term morbidity of nonclosure and closure of the peritoneum at caesarean section. STUDY DESIGN: Participants to a randomised controlled trial were contacted 7 years later. Outcome measures were assessed by a postal questionnaire and reports of subsequent operations. RESULTS: We were able to contact 226 of the 280 women recruited initially, and 144 responded to the questionnaire. Sixty-nine had been allocated to nonclosure of the peritoneum and 75 to closure. Baseline characteristics at randomisation were comparable both between the respondents and the non-respondents, and between originally allocated groups. No statistically significant difference was found between the two groups regarding fertility, abdominal pain, and urinary symptoms. Among 29 reports of subsequent abdominal surgery, 14 mentioned the presence of adhesions (8 in the nonclosure and 6 in the closure group; P=0.47). The number of women reporting at least one significant morbidity was similar between groups (24 in the nonclosure and 19 in the closure group; P=0.72). CONCLUSION: Nonclosure and closure of the peritoneum at caesarean section result in similar long-term morbidity.

Abdominal Pain↗

Does a first trimester dating scan using crown rump length measurement reduce the rate of induction of labour for prolonged pregnancy? An uncompleted randomised controlled trial of 463 women.

OBJECTIVE: To evaluate the effect of a first trimester ultrasound dating scan on the rate of induction of labour for prolonged pregnancy. DESIGN: Randomised controlled trial to include 400 women in each arm of the trial. SETTING: Participating general practices and a district general teaching hospital. POPULATION: Women attending their general practitioner in the first trimester to confirm pregnancy, in whom a first trimester ultrasound scan was not indicated. METHODS: Women randomised to the study group (scan group) underwent an ultrasound dating scan between 8 and 12 weeks, measuring crown-rump length. The estimated date of delivery (EDD) was changed if there was a discrepancy of more than 5 days from the gestation, calculated from the last menstrual period (LMP). For the remaining women (no-scan group), gestation was determined using the LMP. MAIN OUTCOME MEASURES: The rate of induction of labour for prolonged pregnancy. RESULTS: Due to circumstances beyond the researchers' control, recruitment was abandoned when 463 women had been enrolled. The EDD was adjusted in 13 (5.7%) women in the scan group and in 2 (0.9%) in the no-scan group. There was no difference in the rate of induction for prolonged pregnancy between the scan (19 [8.2%]) and the no-scan (17 [7.4%]) groups (relative risk 1.10; 95% CI 0.59-2.07). CONCLUSIONS: Acknowledging the reduced numbers recruited for study, it is concluded that there is no evidence that a first trimester ultrasound dating scan reduces the rate of induction of labour for prolonged pregnancy and may result in a more expensive healthcare strategy.

Adult↗

Patients with cancer holding their own records: a randomised controlled trial.

BACKGROUND: The burden of cancer care in general practice is increasing. Patient-held records may facilitate effective, coordinated care, but no randomised controlled trials of their use in cancer care have been conducted, and concerns about possible negative effects remain. AIM: To evaluate the use of a supplementary patient-held record in cancer care. METHOD: Six hundred and fifty radiotherapy outpatients with any form of cancer were randomised either to hold a supplementary record or to receive normal care. It was explained to record holders that the supplementary record was intended to improve communication with health professionals and act as an aide memoire. After three months, patients' satisfaction with communication and with participation in their own care were assessed. Global health status, emotional functioning, and cognitive functioning were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire. RESULTS: There were no significant differences between groups in any of the outcome measures. Patients in both groups expressed a high level of satisfaction with communication and participation in their care. Mean (SD) scores in the intervention and control groups were: global health status, 66.8 (24.2) and 65.3 (23.7); emotional functioning, 75.0 (24.6) and 77.4 (22.8); cognitive functioning, 84.5 (21.0) and 84.0 (21.3). CONCLUSION: A supplementary patient-held record for radiotherapy outpatients appears to have no effect on satisfaction with communication, participation in care, or quality of life.

Aged↗

A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with inoperable oesophageal cancer.

OBJECTIVES: To compare whether treatment with self-expanding metal stents (SEMS) is more cost-effective than treatment with conventional modalities in patients with inoperable oesophageal cancer. Quality of life effects were also considered. DESIGN: A multicentre pragmatic, randomised controlled trial with health economic analysis. SETTING: Seven NHS hospitals selected to represent a cross-section of UK hospitals in terms of facilities and staffing. PARTICIPANTS: All patients attending the centres with oesophageal cancer deemed unsuitable for surgery were assessed for inclusion in the main trial; 217 patients were randomised. A health state utilities substudy was also performed in 71 patients who had previously received curative surgery for oesophageal cancer. INTERVENTIONS: Eligible patients were randomised to one of four treatment groups within two study arms. Assessments were performed at enrolment, 1 week following treatment and thereafter at 6-weekly intervals until death, with prospective data collection on complications and survival. Structured interviews to elicit patient preferences to health states and treatments were performed in a substudy. MAIN OUTCOME MEASURES: Dysphagia grade and quality of life were examined at 6 weeks. Survival, resources consumed from randomisation to death and quality-adjusted life-years were also considered. RESULTS: There was no difference in cost or effectiveness between SEMS and non-SEMS therapies, and 18-mm SEMS had equal effectiveness to, but less associated pain than, 24-mm SEMS. Rigid intubation was associated with a worse quality of swallowing and increased late morbidity. Bipolar electrocoagulation and ethanol tumour necrosis were poor in primary palliation. A survival advantage was found for non-stent therapies, but there was a significant delay to treatment. The length of stay accounts for the majority of the cost to the NHS. Patients were found to have distinct individual treatment preferences. CONCLUSIONS: It was suggested that rigid tubes and 24-mm SEMS should no longer be recommended and bipolar electrocoagulation and ethanol tumour necrosis should not be used for primary palliation. The choice in palliation would between non-stent and 18-mm SEMS treatments, with non-stent therapies being made more available and accessible to reduce delay. A multidisciplinary team approach to palliation is also suggested. A randomised controlled clinical trial of 18-mm SEMS versus non-stent therapies with survival and quality of life end-points would be helpful, as would an audit of palliative patient admissions to determine the reasons and need for inpatient hospital care, with a view to implementing cycle-associated change to reduce inpatient stay. A study of delays in palliative radiotherapy treatment is also suggested, with a view to implementing cycle-associated change to reduce waiting time.

Aged↗

Satisfaction with midwife-managed care in different time periods: a randomised controlled trial of 1299 women.

OBJECTIVE: To compare women's satisfaction with midwife-managed care with 'shared care' over three different time periods. DESIGN: Randomised controlled trial. SETTING: Glasgow Royal Maternity Hospital, Glasgow, UK. PARTICIPANTS: 1299 women experiencing normal pregnancy (consent rate: 82%). Six hundred and forty-eight women were randomised to midwife-managed care and 651 to 'shared care'. METHODS: Three self-report questionnaires were sent to women's homes. The questionnaires examined: satisfaction with antenatal care at 34-35 weeks' gestation, and satisfaction with intrapartum, hospital- and home-based postnatal care at seven weeks postnatally. The third questionnaire reviewed satisfaction with intrapartum care seven months after delivery. FINDINGS: Women in both groups were satisfied. However, women in the midwife-managed group were more highly satisfied in relation to the dimensions examined: relationships with staff, information transfer, choices and decisions, and social support. The differences between the two groups were evident for all time periods (i.e. antenatal, intrapartum and postnatal periods) and were sustained at seven-month follow-up. This is illustrated in the mean scores for relationships with staff, as measured at 34-35 weeks' gestation (possible range -2; very negative attitudes to 2; very positive attitudes). Women in the midwife-managed group scored a mean of 1.22 compared to 0.74 for the 'shared care' group (mean diff: 0.48; 95% CI: 0.42 to 0.55). While women in both groups were more likely to make positive rather than negative comments in open-ended questions, the midwife-managed group were more likely to make positive comments whereas the 'shared care' group were more likely to make negative comments. CONCLUSION: Midwife-managed care for healthy pregnant women which is integrated into existing services improves satisfaction with antenatal, intrapartum and postnatal care.

Adult↗

Parenteral metoclopramide for acute migraine: meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the evidence from controlled trials on the efficacy and tolerability of parenteral metoclopramide for acute migraine in adults. DATA SOURCES: Cochrane Central Register of Controlled Trials, Medline, Embase, LILACS, CINAHL, conference proceedings, clinical practice guidelines, and other sources. SELECTION CRITERIA: Randomised controlled trials of parenteral metoclopramide for acute migraine in adults. RESULTS: We reviewed 596 potentially relevant abstracts and found 13 eligible trials totalling 655 adults. In studies comparing metoclopramide with placebo, metoclopramide was more likely to provide significant reduction in migraine pain (odds ratio 2.84, 95% confidence interval 1.05 to 7.68). Used as the only agent, metoclopramide showed mixed effectiveness when compared with other single agents. Heterogeneity of studies for combination treatment prevented statistical pooling. Treatments that did include metoclopramide were as, or more, effective than comparison treatments for pain, nausea, and relapse outcomes reported in all studies. CONCLUSIONS: Metoclopramide is an effective treatment for migraine headache and may be effective when combined with other treatments. Given its non-narcotic and antiemetic properties, metoclopramide should be considered a primary agent in the treatment of acute migraines in emergency departments.

Adult↗

Efficacy of cognitive-behavioural therapy by general practitioners for unexplained fatigue among employees: Randomised controlled trial.

BACKGROUND: Fatigue is a common complaint that may lead to long-term sick leave and work disability. AIMS: To assess the efficacy of cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue among employees. METHOD: A randomised controlled trial, using a pre-randomisation design in primary care, investigated 151 employees on sick leave with fatigue. Participants in the experimental group were offered five to seven 30 min sessions of cognitive-behavioural therapy by a general practitioner; those in the control group were offered no treatment. Main outcome measures (fatigue severity, self-reported absenteeism, registered absenteeism and clinical recovery) were assessed at 4 months, 8 months and 12 months. RESULTS: At baseline, 44% of the patients already met research criteria for chronic fatigue syndrome. There was no significant difference between the experimental group and the control group on primary or secondary outcomes at any point. CONCLUSIONS: Cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue did not prove to be an effective intervention. Since these doctors were unable to deliver this therapy effectively under ideal circumstances, it is unlikely that doctors in routine practice would be more successful in doing so.

Adult↗

Falls prevention in residential care homes: a randomised controlled trial.

OBJECTIVE: to determine the effect of risk factor modification and balance exercise on falls rates in residential care homes. DESIGN: cluster randomised controlled trial. PARTICIPANTS: 196 residents (aged 60 years or over) in 20 residential care homes were enrolled (38% response rate). Homes were randomly allocated to intervention and control arms. A total of 102 residents were consigned to the intervention arm and 94 to the control arm. INTERVENTION: a multifactorial falls prevention programme including 3 months gait and balance training, medication review, podiatry and optometry. MAIN OUTCOME MEASURES: number of falls/recurrent falls per person, number of medications per person, and change in Tinetti gait and balance measure. RESULTS: in the intervention group there was a mean of 2.2 falls per resident per year compared with 4.0 in the control group; this failed to reach statistical significance (P = 0.2) once the intra-cluster correlation (ICC, 0.10) had been accounted for. Several risk factors were reduced in the intervention arm. CONCLUSIONS: falls risk factor reduction is possible in residents of care homes. A modest reduction in falls rates was demonstrated but this failed to reach statistical significance.

Accidental Falls↗

Analgesic efficacy of continuous delivery of bupivacaine by an elastomeric balloon infusor after abdominal hysterectomy: a prospective randomised controlled trial.

OBJECTIVE: To investigate the analgesic efficacy and morphine-sparing effect of continuous bupivacaine wound infiltration after abdominal hysterectomy. DESIGN: Prospective, randomised controlled trial. SAMPLE: Fifty-two female ASA I or II patients were enrolled with 26 patients in each of the study and control groups. METHODS: The study group received 0.5% bupivacaine infusion into the incisional (Pfannenstiel) wound via an elastomeric infusor at 2 mL/hr for 48 hours postoperatively plus morphine via a patient controlled analgesia (PCA) pump. The control group had only PCA morphine. RESULTS: There were no significant differences in the visual analogue scores (VAS) for pain nor PCA morphine usage for 48 hours postoperatively CONCLUSION: That continuous infusion of the incisional wound with 0.5% bupivacaine did not confer additional analgesia over PCA morphine after abdominal hysterectomy

Adult↗

Should we advise parents to administer over the counter cough medicines for acute cough? Systematic review of randomised controlled trials.

AIMS: To determine the effectiveness of over the counter (OTC) cough medicines for acute cough in children. METHODS: Systematic review of randomised controlled trials (RCTs). An all language search of the Cochrane Acute Respiratory Infections Group specialised register, Cochrane Controlled Trials Register, Medline, Embase, and the UK Department of Health National Research Register was performed. RCTs comparing oral OTC cough preparations with placebo in children suffering from acute cough as a result of upper respiratory tract infection (URTI) in ambulatory settings, using cough symptoms as an outcome, were included. RESULTS: Six trials involving 438 children met all inclusion criteria. Antitussives, antihistamine-decongestant combinations, other fixed drug combinations, and antihistamines were no more effective than placebo in relieving symptoms of acute cough. Based on a single study, the mucolytic preparation letosteine was superior to placebo, with differences in cough scores ranging from 0.1 to 0.3 points from day 4 to day 10. Most drugs appeared to be well tolerated with a low incidence of mostly minor adverse effects. CONCLUSION: OTC cough medicines do not appear more effective than placebo in relieving symptoms of acute cough. Even if statistically significant, effect sizes were small and of doubtful clinical relevance. The number of trials in each category was small, and the results of this systematic review have to be interpreted with caution. Based on the available evidence from a small number of studies, we cannot recommend OTC cough medicines as a first line treatment for children with acute cough.

Acute Disease↗

Randomised controlled trial of intrapartum fetal heart rate monitoring.

OBJECTIVE: To compare effectiveness of different methods of monitoring intrapartum fetal heart rate. DESIGN: Prospective randomised controlled trial. SETTING: Referral maternity hospital, Harare, Zimbabwe. SUBJECTS: 1255 women who were 37 weeks or more pregnant with singleton cephalic presentation and normal fetal heart rate before entry into study. INTERVENTIONS: Intermittent monitoring of fetal heart rate by electronic monitoring, Doppler ultrasound, use of Pinard stethoscope by a research midwife, or routine use of Pinard stethoscope by attending midwife. MAIN OUTCOME MEASURES: Abnormal fetal heart rate patterns, need for operative delivery for fetal distress, neonatal mortality, Apgar scores, admission to neonatal unit, neonatal seizures, and hypoxic ischaemic encephalopathy. RESULTS: Abnormalities in fetal heart rate were detected in 54% (172/318) of the electronic monitoring group, 32% (100/312) of the ultrasonography group, 15% (47/310) of the Pinard stethoscope group, and 9% (28/315) of the routine monitoring group. Caesarean sections were performed for 28% (89%), 24% (76), 10% (32), and 15% (46) of the four groups respectively. Neonatal outcome was best in the ultrasonography group: hypoxic ischaemic encephalopathy occurred in two, one, seven, and 10 cases in the four groups respectively; neonatal seizures occurred only in the last two groups (six and nine cases respectively); and deaths occurred in eight, two, five, and nine cases respectively. CONCLUSIONS: Abnormalities in fetal heart rate were more reliably detected by Doppler ultrasonography than with Pinard stethoscope, and its use resulted in good perinatal outcome. The use of relatively cheap ultrasound monitors should be further evaluated and promoted in obstetric units caring for high risk pregnancies in developing countries with scarce resources.

Female↗

The effects of postnatal health education for mothers on infant care and family planning practices in Nepal: a randomised controlled trial.

OBJECTIVES: To evaluate impact of postnatal health education for mothers on infant care and postnatal family planning practices in Nepal. DESIGN: Randomised controlled trial with community follow up at 3 and 6 months post partum by interview. Initial household survey of study areas to identify all pregnant women to facilitate follow up. SETTING: Main maternity hospital in Kathmandu, Nepal. Follow up in urban Kathmandu and a periurban area southwest of the city. SUBJECTS: 540 mothers randomly allocated to one of four groups: health education immediately after birth and three months later (group A), at birth only (group B), at three months only (group C), or none (group D). INTERVENTIONS: Structured baseline household questionnaire; 20 minute, one to one health education at birth and three months later. MAIN OUTCOME MEASURES: Duration of exclusive breast feeding, appropriate immunisation of infant, knowledge of oral rehydration solution and need to continue breast feeding in diarrhoea, knowledge of infant signs suggesting pneumonia, uptake of postnatal family planning. RESULTS: Mothers in groups A and B (received health education at birth) were slightly more likely to use contraception at six months after birth compared with mothers in groups C and D (no health education at birth) (odds ratio 1.62, 95% confidence interval 1.06 to 2.5). There were no other significant differences between groups with regards to infant feeding, infant care, or immunisation. CONCLUSIONS: Our findings suggest that the recommended practice of individual health education for postnatal mothers in poor communities has no impact on infant feeding, care, or immunisation, although uptake of family planning may be slightly enhanced.

Breast Feeding↗