SEARCH · PubMed Health

Results for “Randomised Controlled Trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 451 records · Page 25Linked to original sources

PubMed2005

Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial.

OBJECTIVE: To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy. DESIGN: Open, randomised controlled trial. SETTING: 21 general hospitals and three academic centres in the Netherlands. PARTICIPANTS: 300 children aged 2-8 years requiring adenotonsillectomy. INTERVENTION: Adenotonsillectomy compared with watchful waiting. MAIN OUTCOME MEASURES: Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life. RESULTS: During the median follow up period of 22 months, children in the adenotonsillectomy group had 2.97 episodes of fever per person year compared with 3.18 in the watchful waiting group (difference -0.21%, 95% confidence interval -0.54 to 0.12), 0.56 throat infections per year compared with 0.77 (-0.21, -0.36 to -0.06), and 5.47 upper respiratory tract infections per person year compared with 6.00 (-0.53, -0.97 to -0.08). No clinically relevant differences were found for health related quality of life. Adenotonsillectomy was more effective in children with a history of three to six throat infections than in those with none or two. 12 children had surgery related complications. CONCLUSION: Adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy has no major clinical benefits over watchful waiting.

Adenoidectomy↗

PubMed2005

A randomised controlled trial of a new handheld vacuum extraction device.

OBJECTIVE: To evaluate the effectiveness of a new handheld vacuum delivery device. DESIGN: Randomised controlled trial. SETTING: Southmead Hospital, Bristol, UK. POPULATION: One hundred and ninety-four women requiring delivery with vacuum extraction. METHODS: Women were recruited into the study while still in early labour. If during delivery, vacuum extraction was indicated they were then randomly allocated to either a new handheld vacuum device, the Kiwi Omnicup, or to a 'standard' vacuum cup selected by the obstetrician. The 'standard group' consisted of the silastic (66/98, 67%) or the metal cups (32/98, 33%). Study data were recorded at completion of the delivery and at 24-48 hours. An additional brief symptom questionnaire was completed by the mother at 10 days postnatally. Statistical analyses were done on an 'intention-to-treat' basis. MAIN OUTCOME MEASURES: The primary outcome was the successful completion of delivery with the allocated instrument. Secondary outcomes were substantial fetal scalp trauma and substantial maternal trauma. RESULTS: The Omnicup was associated with a significantly higher failure rate than the standard cup [34%vs 21%, odds ratio (OR) = 1.9 (1.01-3.6)]. This difference persisted after adjusting for confounding factors [adjusted OR = 2.25 (1.01-5.0)] and resulted in significantly more forceps deliveries in the Kiwi Omnicup group [22%vs 10%, unadjusted OR = 2.5 (1.1-5.5)]. The caesarean section rates were similar in both groups [9.4%vs 8.2%, OR = 1.2 (0.4-3.2)]. Rates of substantial scalp trauma and maternal trauma were similar in both groups. However, there were more cases of jaundice in the standard cup group [2.3%vs 12.0%, unadjusted OR = 0.18 (0.04-0.82) and adjusted OR = 0.10 (0.01-0.88)]. CONCLUSIONS: The Omnicup is not as successful at achieving a vaginal delivery as the combination of the currently used vacuum cups.

Female↗

PubMed1978

Randomised controlled trial of vancomycin for pseudomembranous colitis and postoperative diarrhoea.

The efficacy of vancomycin in pseudomembranous colitis was assessed in a prospective randomised controlled trial. Forty-four patients with postoperative diarrhoea were allocated to five days' treatment with either 125 mg vancomycin six-hourly or a placebo. Sixteen patients had high titres of the neutralised faecal toxin characteristic of pseudomembranous colitis; nine received vancomycin and seven placebo. At the end of treatment faecal toxins were present in one patient given vancomycin compared with five of the controls. Vancomycin caused the disappearance of Clostridum difficile from the stool in all except one patient, whereas toxicogenic strains of Cl difficile persisted in all but one of the controls. Histological evidence of psuedomembranous colitis had disappeared by the end of treatment in six out of seven patients given vancomycin compared with only one out of seven patients given vancomycin compared with only one out of five patients given placebo. In patients with faecal toxins bowel habit had returned to normal in seven of the vancomycin group compared with only one of the controls, but there was no significant difference in clinical response among patients without faecaal toxins. The results suggest that vancomycin eliminates toxin-producing Cl difficile from the colon and is associated with rapid clinical and histological improvement in patients with pseudomembranous colitis.

Bacterial Toxins↗

PubMed2000

Effect of needle length on incidence of local reactions to routine immunisation in infants aged 4 months: randomised controlled trial.

OBJECTIVE: To compare rates of local reactions associated with two needle sizes used to administer routine immunisations to infants. DESIGN: Randomised controlled trial. SETTING: Routine immunisation clinics in eight general practices in Buckinghamshire. PARTICIPANTS: Healthy infants attending for third primary immunisation due at 16 weeks of age: 119 infants were recruited, and 110 diary cards were analysed. INTERVENTIONS: Immunisation with 25 gauge, 16 mm, orange hub needle or 23 gauge, 25 mm, blue hub needle. MAIN OUTCOME MEASURES: Parental recordings of redness, swelling, and tenderness for three days after immunisation. RESULTS: Rate of redness with the longer needle was initially two thirds the rate with the smaller needle (relative risk 0.66 (95% confidence interval 0.45 to 0.99), P=0.04), and by the third day this had decreased to a seventh (relative risk 0.13 (0.03 to 0.56), P=0.0006). Rate of swelling with the longer needle was initially about a third that with the smaller needle (relative risk 0.39 (0.23 to 0.67), P=0.0002), and this difference remained for all three days. Rates of tenderness were also lower with the longer needle throughout follow up, but not significantly (relative risk 0.60 (0.29 to 1.25), P=0.17). CONCLUSIONS: Use of 25 mm needles significantly reduced rates of local reaction to routine infant immunisation. On average, for every five infants vaccinated, use of the longer needle instead of the shorter needle would prevent one infant from experiencing any local reaction. Vaccine manufacturers should review their policy of supplying the shorter needle in vaccine packs.

Confidence Intervals↗

PubMed2001

A score for predicting risk of death from cardiovascular disease in adults with raised blood pressure, based on individual patient data from randomised controlled trials.

OBJECTIVE: To create a risk score for death from cardiovascular disease that can be easily used. DESIGN: Data from eight randomised controlled trials of antihypertensive treatment. SETTING: Europe and North America. PARTICIPANTS: 47 088 men and women from trials that had differing age ranges and differing eligibility criteria for blood pressure. MAIN OTUCOME MEASURE: 1639 deaths from cardiovascular causes during a mean 5.2 years of follow up. RESULTS: Baseline factors were related to risk of death from cardiovascular disease using a multivariate Cox model, adjusting for trial and treatment group (active versus control). A risk score was developed from 11 factors: age, sex, systolic blood pressure, serum total cholesterol concentration, height, serum creatinine concentration, cigarette smoking, diabetes, left ventricular hypertrophy, history of stroke, and history of myocardial infarction. The risk score is an integer, with points added for each factor according to its association with risk. Smoking contributed more in women and in younger age groups. In women total cholesterol concentration mattered less than in men, whereas diabetes had more of an effect. Antihypertensive treatment reduced the score. The five year risk of death from cardiovascular disease for scores of 10, 20, 30, 40, 50, and 60 was 0.1%, 0.3%, 0.8%, 2.3%, 6.1%, and 15.6%, respectively. Age and sex distributions of the score from the two UK trials enabled individual risk assessment to be age and sex specific. Risk prediction models are also presented for fatal coronary heart disease, fatal stroke, and all cause mortality. CONCLUSION: The risk score is an objective aid to assessing an individual's risk of cardiovascular disease, including stroke and coronary heart disease. It is useful for physicians when determining an individual's need for antihypertensive treatment and other management strategies for cardiovascular risk.

Adult↗

PubMed2002

Sexual dysfunction in men after treatment for lower urinary tract symptoms: evidence from randomised controlled trial.

OBJECTIVE: To examine the impact on sexual function of treatments for lower urinary tract symptoms in men. DESIGN: Multicentre pragmatic randomised controlled trial of standard surgery (transurethral resection of the prostate), non-contact laser therapy, and conservative management (no active intervention). SETTING: Three clinical centres in the United Kingdom. PARTICIPANTS: 340 men aged between 48 and 90 years with lower urinary tract symptoms related to benign prostatic enlargement. MAIN OUTCOME MEASURES: ICSsex questionnaire items concerned with erectile stiffness, ejaculatory volume, pain or discomfort on ejaculation, whether sex life was spoilt by urinary symptoms. RESULTS: Erectile and ejaculatory dysfunction were common (70%) and problematic at baseline and showed the expected trends with ageing. After treatment, reduced ejaculation was reported in all groups but was not significantly worse after standard surgery than after laser therapy. Erectile function was significantly improved after standard surgery; no significant difference was found between standard surgery and laser therapy (odds ratio 0.70, 95% confidence interval 0.36 to 1.38). Standard surgery was significantly better at relieving pain or discomfort on ejaculation than either conservative management (0.06, 0.007 to 0.49) or laser therapy (0.09, 0.01 to 0.73). CONCLUSIONS: Compared with laser therapy standard surgery for lower urinary tract symptoms has a beneficial effect on aspects of sexual function-particularly in improving erectile function and reducing reported pain or discomfort on ejaculation. Older men who need treatment and want to retain or improve sexual function may thus want to consider standard surgery rather than non-contact laser therapy.

Aged↗

PubMed2003

Proactive asthma care in childhood: general practice based randomised controlled trial.

OBJECTIVES: To assess the feasibility and effectiveness of a general practice based, proactive system of asthma care in children. DESIGN: Randomised controlled trial with cluster sampling by general practice. SETTING: General practices in the northern region of the Australian Capital Territory. PARTICIPANTS: 174 children with moderate to severe asthma who attended 24 general practitioners. INTERVENTION: System of structured asthma care (the 3+ visit plan), with participating families reminded to attend the general practitioner. MAIN OUTCOME MEASURES: Process measures: rates for asthma consultations with general practitioner, written asthma plans, completion of the 3+ visit plan; clinical measures: rates for emergency department visits for asthma, days absent from school, symptom-free days, symptoms over the past year, activity limitation over the past year, and asthma drug use over the past year; spirometric lung function measures before and after cold air challenge. RESULTS: Intervention group children had significantly more asthma related consultations (odds ratio for three or more asthma related consultations 3.8 (95% confidence interval 1.9 to 7.6; P = 0.0001), written asthma plans (2.2 (1.2 to 4.1); P = 0.01), and completed 3+ visit plans (24.2 (5.7 to 103.2); P = 0.0001) than control children and a mean reduction in measurements of forced expiratory volume in one second after cold air challenge of 2.6% (1.7 to 3.5); P = 0.0001) less than control children. The number needed to treat (benefit) for one additional written asthma action plan was 5 (3 to 41) children. Intervention group children had lower emergency department attendance rates for asthma (odds ratio 0.4 (0.2 to 1.04); P = 0.06) and less speech limiting wheeze (0.2 (0.1 to 0.4); P = 0.0001) than control children and were more likely to use a spacer (2.8 (1.6 to 4.7); P = 0.0001). No differences occurred in number of days absent from school or symptom-free day scores. CONCLUSIONS: Proactive care with active recall for children with moderate to severe asthma is feasible in general practice and seems to be beneficial.

Asthma↗

PubMed2004

Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial.

OBJECTIVE: To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy. DESIGN: Open, randomised controlled trial. SETTING: 21 general hospitals and three academic centres in the Netherlands. PARTICIPANTS: 300 children aged 2-8 years requiring adenotonsillectomy. INTERVENTION: Adenotonsillectomy compared with watchful waiting. MAIN OUTCOME MEASURES: Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life. RESULTS: During the median follow up period of 22 months, children in the adenotonsillectomy group had 2.97 episodes of fever per person year compared with 3.18 in the watchful waiting group (difference -0.21, 95% confidence interval -0.54 to 0.12), 0.56 throat infections per person year compared with 0.77 (-0.21, -0.36 to -0.06), and 5.47 upper respiratory tract infections per person year compared with 6.00 (-0.53, -0.97 to -0.08). No clinically relevant differences were found for health related quality of life. Adenotonsillectomy was more effective in children with a history of three to six throat infections than in those with none to two. 12 children had complications related to surgery. CONCLUSION: Adenotonsillectomy has no major clinical benefits over watchful waiting in children with mild symptoms of throat infections or adenotonsillar hypertrophy.

Adenoidectomy↗

PubMed2004

Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of cognitive behaviour therapy for adolescents aged 10-17 years with chronic fatigue syndrome. DESIGN: Randomised controlled trial. SETTING: Department of child psychology. PARTICIPANTS: 71 consecutively referred patients with chronic fatigue syndrome; 36 were randomly assigned to immediate cognitive behaviour therapy and 35 to the waiting list for therapy. INTERVENTION: 10 sessions of therapy over five months. Treatment protocols depended on the type of activity pattern (relatively active or passive). All participants were assessed again after five months. MAIN OUTCOME MEASURES: Fatigue severity (checklist individual strength), functional impairment (SF-36 physical functioning), and school attendance. RESULTS: 62 patients had complete data at five months (29 in the immediate therapy group and 33 on the waiting list). Patients in the therapy group reported significantly greater decrease in fatigue severity (difference in decrease on checklist individual strength was 14.5, 95% confidence interval 7.4 to 21.6) and functional impairment (difference in increase on SF-36 physical functioning was 17.3, 6.2 to 28.4) and their attendance at school increased significantly (difference in increase in percentage school attendance was 18.2, 0.8 to 35.5). They also reported a significant reduction in several accompanying symptoms. Self reported improvement was largest in the therapy group. CONCLUSION: Cognitive behaviour therapy is an effective treatment for chronic fatigue syndrome in adolescents.

Absenteeism↗

PubMed2006

Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial.

OBJECTIVES: To compare endoscopic and open carpal tunnel release surgery among employed patients with carpal tunnel syndrome. DESIGN AND SETTING: Randomised controlled trial at a single orthopaedic department. PARTICIPANTS: 128 employed patients aged 25-60 years with clinically diagnosed and electrophysiologically confirmed idiopathic carpal tunnel syndrome. MAIN OUTCOME MEASURES: The primary outcome was severity of postoperative pain in the scar or proximal palm and the degree to which pain or tenderness limits activities, each rated on a 4 point scale, transformed into a combined score of 0 (none) to 100 (severe pain or tenderness causing severe activity limitation). The secondary outcomes were length of postoperative work absence, severity of symptoms of carpal tunnel syndrome and functional status scores, SF-12 quality of life score, and hand sensation and strength (blinded examiner); follow-up at three and six weeks and three and 12 months. RESULTS: 63 patients were allocated to endoscopic surgery and 65 patients to open surgery, with no withdrawals or dropouts. Pain in the scar or proximal palm was less prevalent or severe after endoscopic surgery than after open surgery but the differences were generally small. At three months, pain in the scar or palm was reported by 33 patients (52%) in the endoscopic group and 53 patients (82%) in the open group (number needed to treat 3.4, 95% confidence interval 2.3 to 7.7) and the mean score difference for severity of pain in scar or palm and limitation of activity was 13.3 (5.3 to 21.3). No differences between the groups were found in the other outcomes. The median length of work absence after surgery was 28 days in both groups. Quality of life measures improved substantially. CONCLUSIONS: In carpal tunnel syndrome, endoscopic surgery was associated with less postoperative pain than open surgery, but the small size of the benefit and similarity in other outcomes make its cost effectiveness uncertain.

Adult↗

PubMed2006

Effectiveness and acceptability of lidocaine spray in reducing perineal pain during spontaneous vaginal delivery: randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness and acceptability of a lidocaine spray in reducing perineal pain during spontaneous vaginal delivery. DESIGN: Randomised controlled trial. SETTING: Consultant led obstetric unit. PARTICIPANTS: 185 women who had a spontaneous vaginal delivery without epidural analgesia. INTERVENTIONS: Topically applied local anaesthetic spray (93 women) and placebo spray (92 women). MAIN OUTCOME MEASURE: Primary outcome measure was pain during delivery (0-100 scale). The 16 secondary outcome measures included second degree perineal trauma during delivery, trauma of the genital tract, and dyspareunia by two months. RESULTS: Lidocaine spray did not reduce pain during spontaneous vaginal delivery: mean 77 and 72 on a scale of 0-100 in the lidocaine and placebo groups, respectively (difference between means 4.8, 95% confidence interval -1.7 to 11.2). Lidocaine spray may reduce genital tract trauma during delivery, in particular second degree perineal trauma. The intervention was highly acceptable to the women and midwives. CONCLUSIONS: Although lidocaine spray applied to the perineum during spontaneous vaginal delivery did not reduce perineal pain, it was acceptable to both the women and the midwives. TRIAL REGISTRATION: Current controlled trials ISRCTN99732966 [controlled-trials.com].

Administration, Topical↗

PubMed2001

Is it in a neonate's best interest to enter a randomised controlled trial?

Clinicians are required to act in the best interest of neonates. However, it is not obvious that entry into a randomised controlled trial (RCT) is in a neonate's best interest because such trials often involve additional onerous procedures (such as intramuscular injections) in return for which the neonate receives unproven treatment or a placebo. On the other hand, neonatology needs to develop its evidence base, and RCTs are central to this task. The solution posited here is based on two points. First, "best interest" is not equivalent to "the best possible interest" only to "best interest within a certain realm". The realm of deliberation when asking the title question is the neonate's health. Deliberating in this realm may involve the exclusion from consideration of some factors that might be thought relevant (such as parental wealth). Furthermore, circumstances may dictate the need to deliberate on other factors that might be thought irrelevant (such as health care resources). Second, deciding on a neonate's best interest does not involve "putting oneself in its shoes". Rather, it involves asking in what it has an interest, or stake. These will include some things in which we all, as human beings, have a stake, such as medical progress. Putting these two points together, in the realm of health the answer to whether RCT entry is in a neonate's best interest is usually very finely balanced. Where this is the case, it is reasonable to invoke a broader notion of best interest and include a broader range of elements in which the neonate has a stake, including medical progress. In this way RCT entry can, usually, be said to be in a neonate's best interest.

Child Advocacy↗

PubMed2006

The fading of reported effectiveness. A meta-analysis of randomised controlled trials.

BACKGROUND: The "real" effect size of a medical therapy is constant over time. In contrast, the effect size reported in randomised controlled trials (RCTs) may change over time because the sum of all kinds of bias influencing the reported effectiveness is not necessarily constant. As this would affect the validity of meta-analyses, we tested the hypothesis that the reported effect size decreases over time. Furthermore, we tested three hypotheses that would explain a possible change. METHODS: Because of well established outcome measures, the lipid-lowering drugs Pravastatin and Atorvastatin (serum low-density lipoprotein cholesterol, LDL-C) and the anti-glaucoma drugs Timolol and Latanoprost (intraocular pressure, IOP) were chosen for this investigation. Studies were identified by a standardized MEDLINE search. RCTs investigating the above identified medications administered as monotherapy, and in defined dosages, were included. Publication year, baseline (= pre-treatment value in the treatment group of interest) and post intervention means, number of patients and the assignment to experimental or control group were extracted for each study. RESULTS: A total of 625 citations were screened; 206 met the inclusion criteria. The reported effect size of Pravastatin (change of reported effect size in five years: -3.22% LDL-C, P < .0001), Timolol (-0.56 mmHg, P < .0001) and Latanoprost (-1.78 mmHg, P = .0074) decreased over time, while there was no significant change for Atorvastatin (+0.31% LDL-C, P = .8618). Multiple regression analysis showed that baseline values were the most important influencing factor; study size or treatment group did not play a significant role. CONCLUSION: The effectiveness of medical therapies reported in RCTs decreases over time in three of the four investigated pharmaceuticals, caused mainly by baseline differences. We call this phenomenon "fading of reported effectiveness". Under this condition the validity of a meta-analysis may be impaired. Therefore we propose to observe this phenomenon in future meta-analyses in order to guarantee a maximum of transparency.

Adrenergic beta-Antagonists↗

PubMed1996

Methodology for a randomised controlled trial of preschool vision screening. A new approach with the 'ALSPAC' project.

We present the methodology of a population-based Randomised Controlled Trial, comparing an intensive programme of primary preschool vision screening by orthoptists with the usual non-specialist screening. The aims of the trial are to compare the effectiveness and costs of intensive orthoptic screening with non-specialist measures. The orthoptic screening programme will be evaluated both as a composite package and in terms of the screening value of the individual tests at specific ages. This trial is nested within a large population-based longitudinal study. Additional demographic and developmental data on the children in the trial are therefore available. The results of the trial will be used to help clarify which methods of preschool ophthalmic population screening are best in terms of disease detection and cost efficiency.

Amblyopia↗

PubMed1996

A randomised controlled trial to assess the relative efficacy of chloroquine, amodiaquine, halofantrine and Fansidar in the treatment of uncomplicated malaria in children.

A randomised controlled trial was carried out to determine the relative efficacy of four commonly used antimalarial drugs in children aged three to twelve years presenting with uncomplicated malaria at the Eldoret District Hospital, Kenya. One hundred and eighty eight children were studied between July 1993 and July 1994. There were no significant baseline differences between treatment groups with respect to age, sex, weight, ethnicity, haemoglobin, white blood cell (WBC) counts, parasite counts, previous exposure to malaria and prior treatment. Of the 188 patients, eleven were lost to follow-up while twelve were discontinued from the study due to poor clinical response. Most of the latter (eight out of twelve) were in the chloroquine group. By day seven, there were significant differences (p = 0.004) in parasite clearance between groups. There were no significant statistical differences between the groups (p = 0.12) with regard to the fever clearance time. However, there was a significant statistical difference (p = 0.00003) between the treatment groups in the cure rates. Halofantrine was the most efficacious drug with 82% of the cases cured followed by fansidar(R)(62%), amodiaquine (55%) and chloroquine (29%). RI and RII resistance were observed in all the treatment groups, i.e. halofantrine (18%), fansidar (38%), amodiaquine (45%) and chloroquine (67%) while RIII resistance was only observed in the chloroquine group(3%).

Amodiaquine↗

PubMedDate not supplied

Routine vs selective episiotomy: a randomised controlled trial. Argentine Episiotomy Trial Collaborative Group.

Episiotomy is a widely-done intervention in childbirth, regardless of poor scientific evidence of its benefits. This randomised controlled trial compares selective with routine use of a mediolateral episiotomy for women having first and second deliveries in 8 public maternity units in Argentina. 2606 women participated; 1555 were nulliparous (778 in the selective group and 777 in the routine group) and 1051 primiparous (520 in the selective group and 531 in the routine group). The two interventions compared were selective (limited to specified maternal or fetal indications), and routine episiotomy (following the hospital's previous policy). Episiotomy was done in 30.1% of deliveries in the selective, and 82.6% in the routine group. The main outcome measure was severe perineal trauma. Severe perineal trauma was uncommon in both groups but was slightly less frequent in the selective group (1.2% vs 1.5%). Anterior perineal trauma was more common in the selective group but posterior perineal surgical repair, perineal pain, healing complications, and dehiscence were all less frequent in the selective group. Routine episiotomy should be abandoned and episiotomy rates above 30% cannot be justified.

Argentina↗

PubMed2005

Folic acid supplements in pregnancy and birth outcome: re-analysis of a large randomised controlled trial and update of Cochrane review.

Periconceptual folic acid prevents neural tube defects. The effect of folic acid taken throughout pregnancy is unclear, however. We re-analysed data from a large randomised controlled trial performed between 1966 and 1967 and combined the results with those from trials included in a Cochrane review. A total of 2928 women were randomised: 1977 were allocated to placebo, 466 to folic acid 200 microg/day and 485 to folic acid 5 mg/day. Folic acid supplementation was not associated with any difference in mean birthweight, placental weight or gestational age. When combined with trials in the Cochrane review folic acid at high doses was associated with reduced risk of low birthweight (pooled relative risk 0.73 [95% CI 0.53, 0.99]). We found no conclusive evidence of benefit for folic acid supplementation in pregnant women given from time of booking onwards.

Adult↗

PubMed1997

Nitric oxide donors induce ripening of the human uterine cervix: a randomised controlled trial.

OBJECTIVE: To determine whether nitric oxide donors can induce cervical ripening before surgical termination of pregnancy in the first trimester. DESIGN: Prospective, randomised controlled trial. SETTING: Department of Obstetrics and Gynaecology, Royal Infirmary, Glasgow. PARTICIPANTS: Forty-eight primigravid women undergoing surgical termination of pregnancy before 12 weeks of gestation. METHODS: The women were randomised to receive per vaginam before surgery either the nitric oxide donor isosorbide mononitrate, the nitric oxide donor glyceryl trinitrate, the prostaglandin analogue gemeprost, or no treatment. MAIN OUTCOME MEASURES: The cumulative force required to dilate the cervix to 8 mm was measured objectively and the cervical diameter before surgical dilatation was recorded. RESULTS: Following isosorbide mononitrate or gemeprost, a lower cumulative force was required to dilate the cervix to 8 mm and a higher cervical diameter before dilatation was recorded. Pretreatment with glyceryl trinitrate reduced the cumulative force required to dilate the cervix but had no effect on cervical diameter. CONCLUSIONS: Like the prostaglandin analogue gemeprost, the nitric oxide donors isosorbide mononitrate and glyceryl trinitrate can effect cervical ripening. Nitric oxide donors may provide an alternative to prostaglandins for cervical ripening before surgical procedures in the first trimester.

Abortifacient Agents, Nonsteroidal↗