PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Randomized controlled trials”

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 1,243 records · Page 69Linked to original sources
PubMed2000

Metoclopramide for preventing pneumonia in critically ill patients receiving enteral tube feeding: a randomized controlled trial.

OBJECTIVE: To determine whether metoclopramide prevents nosocomial pneumonia in intensive care unit (ICU) patients receiving enteral feeding by a nasogastric tube. DESIGN: Prospective, randomized, controlled trial. SETTING: ICU of a university hospital. PATIENTS: A total of 305 consecutive patients requiring placement of a nasogastric tube for >24 hrs. INTERVENTIONS: Patients were randomized to receive either 10 mg of metoclopramide or placebo at 8-hr intervals through the nasogastric tube. MEASUREMENTS AND MAIN RESULTS: A total of 174 patients received placebo and 131 received metoclopramide. Baseline characteristics in the two treatment groups were comparable. Of the 305 patients, 46 developed nosocomial pneumonia, which was 24 patients (13.7%) in the placebo group and 22 (16.8%) in the metoclopramide group (p > .05). Patients in the placebo group developed pneumonia earlier than patients receiving metoclopramide (4.46+/-1.72 days [mean +/- SD[rsqb] after ICU admission compared with 5.95+/-1.78 days; p = .006). Subgroup analysis showed that metoclopramide did not reduce the frequency rate of pneumonia in patients with tracheal intubation (19 [25.3%] of 75 patients receiving metoclopramide vs. 21 [21.2%] of 99 patients receiving placebo) or those receiving mechanical ventilation (17 [25.6%] of 58 patients receiving metoclopramide vs. 20 [29.3%] of 78 patients receiving placebo). The mortality rate also did not differ in the two treatments groups (56% in the metoclopramide group vs. 53% in the placebo group; p > .05). CONCLUSIONS: Although metoclopramide delayed the development of nosocomial pneumonia, it did not decrease its frequency rate and had no effect on the mortality rate in critically ill patients receiving nasogastric enteral feeding.

Antiemetics↗
PubMedDate not supplied

Skin exposure during conventional phototherapy in preterm infants: A randomized controlled trial.

OBJECTIVE: To assess the effect of reduced skin exposure in preterm infants receiving overhead phototherapy treatment on total serum bilirubin (TSB). METHODS: Randomized controlled trial. Preterm infants (>1500 g birthweight and < or = 36 weeks gestation) were randomized to being nursed either partially clothed with only disposable nappies and in posturally supported positions (n = 30) or naked without postural support (n = 29). Primary outcome was mean TSB percentage change at 24 h of completed conventional overhead phototherapy treatment (irradiance of 6 microW cm(-2)/nm at a wavelength of 425-475 nm). The incidence of rebound jaundice, number of infants continuing to receive phototherapy treatment at 24 h periods, parental stress, mother-infant interaction and mean TSB percentage change at 24 h of completed conventional overhead phototherapy treatment were examined. RESULTS: Mean TSB percentage change at 24 h of completed treatment for the partially clothed group was 15.4% (+/-18) and for the naked group 19% (+/-15) (mean difference 3.6% 95% CI -5.1, 12.3). No other outcomes were significantly affected by reduced skin exposure to overhead phototherapy treatment. CONCLUSION: Our results show no statistically significant difference in TSB level change using either nursing practice.

Bilirubin↗
PubMed2004

Insulin therapy for critically ill hospitalized patients: a meta-analysis of randomized controlled trials.

BACKGROUND: Hyperglycemia is common in critically ill hospitalized patients, and it is associated with adverse outcomes, including increased mortality. The objective of this meta-analysis was to determine the effect of insulin therapy initiated during hospitalization on mortality in adult patients with a critical illness. METHODS: An electronic search in the English-language articles of MEDLINE and the Cochrane Controlled Clinical Trials Register and a hand search of key journals and relevant review articles were performed. Randomized controlled trials that reported mortality data on critically ill hospitalized adult patients who were treated with insulin were selected. Data on patient demographics, hospital setting, intervention (formulation and dosage of insulin, delivery method, and duration of therapy), mortality outcomes, adverse events, and methodological quality were extracted. RESULTS: Thirty-five trials met the inclusion criteria. Combining data from all trials using a random-effects model showed that insulin therapy decreases short-term mortality by 15% (relative risk [RR], 0.85; 95% confidence interval [CI], 0.75-0.97). In subgroup analyses, insulin therapy decreased mortality in the surgical intensive care unit (RR, 0.58; 95% CI, 0.22-0.62), when the aim of therapy was glucose control (RR, 0.71; 95% CI, 0.54-0.93), and in patients with diabetes mellitus (RR, 0.73; 95% CI, 0.58-0.90). A near-significant trend toward decreasing mortality was seen in patients with acute myocardial infarction who did not receive reperfusion therapy (RR, 0.84; 95% CI, 0.71-1.00). No randomized trials of insulin in the medical intensive care unit were identified. CONCLUSION: Insulin therapy initiated in the hospital in critically ill patients has a beneficial effect on short-term mortality in different clinical settings.

Adult↗
PubMed2000

Does team midwife care increase satisfaction with antenatal, intrapartum, and postpartum care? A randomized controlled trial.

BACKGROUND: Although policymakers have suggested that improving continuity of midwifery can increase women's satisfaction with care in childbirth, evidence based on randomized controlled trials is lacking. New models of care, such as birth centers and team midwife care, try to increase the continuity of care and caregiver. The objective of this study was to evaluate the effect of a new team midwife care program in the standard clinic and hospital environment on satisfaction with antenatal, intrapartum, and postpartum care in low-risk women in early pregnancy. METHODS: Women at Royal Women's Hospital in Melbourne, Australia, were randomly allocated to team midwife care (n = 495) or standard care (n = 505) at booking in early pregnancy. Doctors attended most women in standard care, and continuity of the caregiver was lacking. Satisfaction was measured by means of a postal questionnaire 2 months after the birth. RESULTS: Team midwife care was associated with increased satisfaction, and the differences between the groups were most noticeable for antenatal care, less noticeable for intrapartum care, and least noticeable for postpartum care. The study found no differences between team midwife care and standard care in medical interventions or in women's emotional well-being 2 months after the birth. CONCLUSION: Conclusions about which components of team midwife care were most important to increased satisfaction with antenatal care were difficult to draw, but data suggest that satisfaction with intrapartum care was related to continuity of the caregiver.

Continuity of Patient Care↗
PubMed2001

Effect of acupuncture on nausea of pregnancy: a randomized, controlled trial.

OBJECTIVE: To compare acupuncture with sham (placebo) acupuncture for treatment of nausea of pregnancy. METHODS: In a subject- and observer-masked, randomized, controlled trial in the maternity unit at Exeter Hospital, we gave 55 women between 6 and 10 weeks' gestation genuine, traditional-style acupuncture or sham treatment with a cocktail stick on three or four occasions over 3 weeks. The main outcome measure was nausea score, as determined by subject report on a visual analogue scale in a daily diary. Anxiety and depression also were assessed. RESULTS: Nausea scores decreased from a median of 85.5 (interquartile range 71.25-89.75) to 47.5 (interquartile range 29.25-69.5) in the acupuncture group and from 87.0 (interquartile range 73.0-90.0) to 48.0 (interquartile range 14.0-80.0) in the sham treatment group. There was strong evidence of a time effect (P <.001) but no evidence of a group effect (P =.9) or a group-time interaction (P =.8). Similarly, there was evidence of time effects in scores for anxiety and depression but no group differences. The study had a power of 95% to detect significant differences in nausea scores. CONCLUSION: Acupuncture was as effective in treating nausea of pregnancy as a sham procedure.

Acupuncture Therapy↗
PubMed2003

Early labour assessment and support at home: a randomized controlled trial.

OBJECTIVE: To compare childbirth outcomes of women prospectively randomized to receive early labour assessment and support either through a home visit or by telephone triage. METHODS: Women in early labour, upon seeking prior telephone advice on whether or not they were ready to be admitted to BC Women's Hospital (as was standard hospital practice), were voluntarily randomized to receive either a home visit by an obstetrical nurse or telephone triage. RESULTS: One hundred seventeen women were randomized to receive home care and 120 to receive telephone triage. Significantly fewer women in the home care group arrived at hospital in the latent stage of labour, compared to women in the telephone triage group (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.19-0.72). Significantly fewer women in the home care group received narcotics (OR, 0.55; 95% CI, 0.32-0.96). Differences observed in use of epidural analgesia (OR, 0.64; 95% CI, 0.36-1.16) were not statistically significant. Newborns in the home care group were significantly less likely to be admitted to a level II observation nursery (OR, 0.13; 95% CI, 0.03-0.60). More women in the home care group would recommend this type of care to a friend (P = 0.001). CONCLUSION: Our findings suggest an association of early labour assessment at home with both admission to hospital in the active phase of labour and reduction in use of analgesia during labour. Early labour support at home was associated with reduced rates of admission of neonates to a level II observation nursery, possibly secondary to reduced exposure to analgesics. Early labour care at home by hospital-based obstetrical nurses is safe and acceptable to women, and may offer advantages in terms of reduced interventions and more vigorous neonates.

Adult↗
PubMed1985

Effect of perioperative platelet inhibition on postcarotid endarterectomy mural thrombus formation. Results of a prospective randomized controlled trial using aspirin and dipyridamole in humans.

A prospective randomized double-blind trial was conducted to study the effect of platelet-inhibiting drugs on mural thrombus formation after carotid endarterectomy. Twenty-two patients undergoing carotid endarterectomy were randomly assigned to perioperative administration of an aspirin/dipyridamole combination or a placebo, and the postoperative results were compared. Autologous indium-111-labeled platelets were injected postoperatively, and platelet deposition was measured at the endarterectomy site. It was found that the treated group had a significant reduction in platelet accumulation compared with the placebo group. The results suggest that the perioperative use of aspirin/dipyridamole may reduce the risk of operative stroke and the long-term risk of repeat carotid stenosis.

Aged↗
PubMed2002

Total colonic dye-spray increases the detection of diminutive adenomas during routine colonoscopy: a randomized controlled trial.

BACKGROUND: Small adenomas may be missed during colonoscopy, but chromoscopy has been reported to enhance detection. The aim of this randomized-controlled trial was to determine the effect of total colonic dye spray on adenoma detection during routine colonoscopy. METHODS: Consecutive outpatients undergoing routine colonoscopy were randomized to a dye-spray group (0.1% indigo carmine used to coat the entire colon during withdrawal from the cecum) or control group (no dye). RESULTS: Two hundred fifty-nine patients were randomized, 124 to the dye-spray and 135 to the control group; demographics, indication for colonoscopy, and quality of the preparation were similar between the groups. Extubation from the cecum took a median of 9:05 minutes (range: 2:48-24:44 min) in the dye-spray group versus 4:52 minutes (range: 1:42-15:21 min) in the control group (p < 0.0001). The proportion of patients with at least 1 adenoma and the total number of adenomas were not different between groups. However, in the dye-spray group significantly more diminutive adenomas (<5 mm) were detected proximal to the sigmoid colon (p = 0.026) and more patients were identified with 3 or more adenomas (p = 0.002). More non-neoplastic polyps were detected throughout the colon in the dye-spray group (p = 0.003). There were no complications. CONCLUSIONS: Dye-spray increases the detection of small adenomas in the proximal colon and patients with multiple adenomas, but long-term outcomes should be studied to determine the clinical value of these findings.

Adenoma↗
PubMed2004

Immunocytochemical study on endothelial integrity of saphenous vein grafts harvested by minimally invasive surgery with the use of vascular mayo stripers. A randomized controlled trial.

OBJECTIVES: The aim of this study is to compare the endothelial integrity of saphenous vein grafts harvested by minimally invasive surgery and veins harvested conventionally for coronary artery bypass surgery in 200 participants who were assigned to interventions by using random allocation. DESIGN: Randomized controlled trial. Methods. Immunocytochemistry with anti-CD 31 antibodies and anti-nitric oxide synthase (NOS) antibodies were employed to identify the endothelial integrity. RESULTS: The CD 31 immunostaining showed that the endothelial cell integrity of the minimally invasive harvested veins was preserved in 82+/-13% of the circumference of luminal endothelium, while in conventionally harvested grafts it was reduced to 64+/-15% (p=0.05).> This was associated with the lack of CD 31 expression in vasa vasorum (10 and 18%) in both groups, respectively, (p=0.02). The NOS immunostaining revealed that the endothelial integrity of the minimally invasive harvested grafts was preserved in 96+/-4% of the luminal endothelium circumference as compared to 74+/-10% in conventionally harvested grafts (p=0.05). The percentage of cases with the lack of NOS expression in all vasa vasorum was 12 and 21%, in G1 and G2, respectively, (p=0.02). CONCLUSION: The endothelial integrity of saphenous vein grafts harvested by minimally invasive surgery is better preserved than with the grafts obtained by the conventional manner. This could play an important role in improving vein graft patency rates.

Aged↗
PubMed1996

Early tracheal extubation after coronary artery bypass graft surgery reduces costs and improves resource use. A prospective, randomized, controlled trial.

BACKGROUND: Economics has caused the trend of early tracheal extubation after cardiac surgery, yet no prospective randomized study has directly validated that early tracheal extubation anesthetic management decreases costs when compared with late extubation after cardiac surgery. METHODS: This prospective, randomized, controlled clinical trial was designed to evaluate the cost savings of early (1-6 h) versus late tracheal extubation (12-22 h) in patients after coronary artery bypass graft (CABG) surgery. The total cost for the services provided for each patient was determined for both the early and late groups from hospital admission to discharge home. All costs applicable to each of the services were classified into direct variables, direct fixed costs, and overhead (an indirect cost). Physician fees and heart catheterization costs were included. The total service cost was the sum of unit workload and overhead costs. RESULTS: One hundred patients having elective CABG who were younger than 75 yr were studied. Including all complications, early extubation (n = 50) significantly reduced cardiovascular intensive care unit (CVICU) costs by 53% (P < 0.026) and the total CABG surgery cost by 25% (P < 0.019) when compared with late extubation (n = 50). Forty-one patients (82%) in each group were tracheally extubated within the defined period. In the early extubation group, the actual departmental cost savings in CVICU nursing and supplies was 23% (P < 0.005), in ward nursing and supplies was 11% (P < 0.05), and in respiratory therapy was 12% (P < 0.05). The total cost savings per patient having CABG was 9% (P < 0.001). Further cost savings using discharge criteria were 51% for CVICU nursing and supplies (P < 0.001), 9% for ward nursing and supplies (P < 0.05), and 29% for respiratory therapy (P < 0.001), for a total cost savings per patient of 13% (P < 0.001). Early extubation also reduced elective case cancellations (P < 0.002) without any increase in the number of postoperative complications and readmissions. CONCLUSIONS: Early tracheal extubation anesthetic management reduces total costs per CABG surgery by 25%, predominantly in nursing and in CVICU costs. Early extubation reduces CVICU and hospital length of stay but does not increase the rate or costs of complications when compared with patients in the late extubation group. It shifts the high CVICU costs to the lower ward costs. Early extubation also improves resource use after cardiac surgery when compared with late extubation.

Aged↗
PubMed1999

A randomized controlled trial of day hospital and day centre therapy.

OBJECTIVE: To compare the outcome of day hospital to day centre rehabilitation. DESIGN: Single blind randomized controlled trial with home assessments at baseline (twice), six weeks and three months. SETTING: Mainly rural health district. Day hospital and social services day centres in market towns. SUBJECTS: One hundred and five physically disabled older patients living at home referred for day hospital rehabilitation or maintenance before discharge from hospital (66) or referred as outpatients (39). INTERVENTIONS: Day hospital treatment or day centre rehabilitation by a physiotherapist and two health support workers. MAIN OUTCOME MEASURES: Barthel Index, Philadelphia Geriatric Morale Scale and Caregiver Strain Index. RESULTS: More day centre (23/55) than day hospital patients (6/50) (p <0.001) withdrew from allocated treatment by choice or because of operational difficulties. Both groups improved significantly in functional ability and reduction of care-giver strain by three months but there was no significant difference between groups. The mean improvement in Barthel Index (standard error) for day hospital = +1.5 (0.41) (n = 34) and day centres = +1.5 (0.48) (n = 38). The mean difference (95% confidence interval) between day hospital and day centre was 0 (-1.28, +1.28). Likewise the mean Philadelphia Geriatric Morale Scale improvement for day hospital +1.8 (0.66) (n = 35) and day centres was +0.9 (0.63) (n = 38). The mean difference was -0.88 (-2.7, +0.95). The mean reduction in Caregiver Strain for day hospital was -1.45 (0.5) (n = 23) and day centre was -1.59 (0.47) (n = 27). The difference was -0.14 (1.52, +1.24). (These analyses are all on an intention-to-treat basis.) CONCLUSION: Whilst the improvement in functional ability and care-giver strain was similar in both groups, day centre rehabilitation was less popular and had practical difficulties. If these difficulties can be overcome the model should be tested elsewhere.

Aged↗
PubMed1996

Effect of mandatory radiology consultation on inpatient imaging use. A randomized controlled trial.

OBJECTIVE: To determine if a mandatory radiology consultation service can decrease radiology resource use on inpatient internal medicine services. DESIGN AND SETTING: Randomized controlled trial on 4 internal medicine services at a university hospital. PATIENTS AND OTHER PARTICIPANTS: Six radiologists performed the intervention on 2 internal medicine services over a 12-month period. A total of 1022 patients were admitted to the 2 intervention services and 1178 patients were admitted to the 2 control services. Each was staffed by an attending internist and 3 house officers. INTERVENTION: Each radiology examination required approval by the attending radiologist before it was performed. MAIN OUTCOME MEASURE: Relative resource costs (relative value units [RVUs]), number of examinations per patient, proportion of patients with 1 or more tests, and mean length of stay (LOS). RESULTS: Mean RVUs for the intervention group were 356.1, and for the control group, 336.0 (P=.5). Mean examinations per patient for both groups was 4.4. Mean LOS for the intervention group was 6.0 days, and for the control group, 6.1 days (P=.8). CONCLUSIONS: An inpatient radiology consultation service, with a goal to reduce resource use, did not achieve its goal. A more appropriate use of time and expense for radiology utilization management may be in the outpatient setting.

Female↗
PubMed2005

A randomized controlled trial to test an HIV-prevention intervention for Latino gay and bisexual men: lessons learned.

At the time of this writing, no randomized controlled trial (RCT) of an intervention to reduce unsafe sex among Latino gay and bisexual men (LGBM) had been published. We report the results of an RCT conducted in New York City in which 180 LGBM were assigned either to an intervention developed specifically for this population or to a wait-list control group. The intervention was based on empowerment theory and used factors identified in prior research as determinants of unsafe sex. By eligibility criteria, all men had engaged in unprotected anal intercourse (UAI) within two months of the baseline assessment. At first (two months) and second (six months later) follow-up assessments, approximately half of the men in the experimental group reported no UAI. Yet, a similar proportion of the control group also reported no UAI. Baseline data indicate that although the men had been the subject of social oppression and sexual prejudice (homophobia), they did not feel disempowered, externally controlled or fatalistic, and they reported self-efficacy and intentionality to enact safer sex. Lessons learned are discussed, as well as notes of caution for future research employing a similar conceptual framework.

Adolescent↗
PubMed2006

Effects of early treatment with statins on short-term clinical outcomes in acute coronary syndromes: a meta-analysis of randomized controlled trials.

CONTEXT: The short-term effects of early treatment with statins in patients after the onset of acute coronary syndromes (ACS) for the outcomes of death, myocardial infarction (MI), and stroke are unclear. OBJECTIVE: To evaluate relevant outcomes of patients from randomized controlled trials comparing early statin therapy with placebo or usual care at 1 and 4 months following ACS. DATA SOURCES AND STUDY SELECTION: Systematic search of electronic databases (MEDLINE, EMBASE, PASCAL, Cochrane Central Register) from their inception to August 2005, which was supplemented by contact with experts in the field. Two reviewers independently determined the eligibility of randomized controlled trials that compared treatment with statins with a control, were initiated within 14 days after onset of ACS, and had a minimal follow-up of 30 days. Trials with cerivastatin were only included in a sensitivity analysis. DATA EXTRACTION: Information on baseline characteristics of included trials and patients, reported methodological quality, lipid levels, and clinical outcome was independently extracted by 2 investigators. Investigators from each included trial contributed additional data if necessary. DATA SYNTHESIS: Twelve trials involving 13 024 patients with ACS were included in the meta-analysis. The risk ratios for the combined end point of death, MI, and stroke for patients treated with early statin therapy compared with control therapy were 0.93 (95% confidence interval [CI], 0.80-1.09; P = .39) at 1 month and 0.93 (95% CI, 0.81-1.07; P = .30) at 4 months following ACS. There were no statistically significant risk reductions from statins for total death, total MI, total stroke, cardiovascular death, fatal or nonfatal MI, or revascularization procedures (percutaneous coronary intervention or coronary artery bypass graft surgery). Sensitivity analyses with restriction to trials of high quality or with additional data from a large trial using cerivastatin indicated summary risk ratios even closer to 1. CONCLUSION: Based on available evidence, initiation of statin therapy within 14 days following onset of ACS does not reduce death, MI, or stroke up to 4 months.

Angina, Unstable↗
PubMed2005

Randomized controlled trial comparing Merocel and RapidRhino packing in the management of anterior epistaxis.

OBJECTIVES: A prospective non-blinded randomized controlled trial to compare the efficacy of Merocel and RapidRhino nasal packs in the treatment of anterior epistaxis. METHODS: Fifty-two consecutive participants admitted with anterior epistaxis refractory to digital pressure or nasal cautery were randomized to treatment using one or other of the nasal packs. Patients who required repacking because of continued bleeding, only the first packs were included in the analysis. Haemostatic properties of the packs were measured by grading bleeding during and after removal of the pack (0-4, where four is uncontrollable) and by noting if the nose was re-packed or not. The difficulty of insertion and removal (graded 0-3 by clinician where 3 is the most difficult) and the participant's perception of discomfort (graded 0-10, where 10 is the worst pain) during insertion and removal of the pack were also measured. RESULTS: For bleeding, the mean values for Merocel and RapidRhino during packing and after pack removal were not significant (P = 0.38 and 0.82 respectively). The mean values of patient discomfort on insertion were 6.9 and 5.0 (P = 0.01), and for discomfort on removal were 4.6 and 3.4 (P = 0.05) respectively. The mean values of insertion graded by the clinician were 1.7 and 0.9 (P = 0.0003), and for removal were 1.4 and 0.4 (P < 0.0001). CONCLUSIONS: RapidRhino and Merocel are equally effective in the control of anterior epistaxis but RapidRhino is significantly more comfortable for the patient and easier for the healthcare worker during insertion and removal.

Adult↗
PubMed1994

Methotrexate and misoprostol vs misoprostol alone for early abortion. A randomized controlled trial.

OBJECTIVE: To compare the safety and efficacy of early abortion by administration of methotrexate and misoprostol vs administration of misoprostol alone. DESIGN: Randomized controlled trial. SETTING: San Francisco (Calif) General Hospital. PATIENTS: Pregnant women at 56 days' gestation or less seeking elective abortion. Sixty-three women volunteered for the trial; 61 completed the study and are included in the analysis. INTERVENTION: Intramuscular administration of 50 mg of methotrexate per square meter of body surface area followed 3 days later by vaginal administration of 800 micrograms of misoprostol (group 1) or the same dose of misoprostol given alone (group 2). The misoprostol dose was repeated 24 hours later if abortion had not occurred. MAIN OUTCOME MEASURES: Successful abortion, duration of vaginal bleeding, side effects, and change in beta-human chorionic gonadotropin (beta-hCG) level. An abortion was considered successful if the pregnancy ended without requiring a surgical procedure. RESULTS: Complete abortion occurred in 28 (90%) of 31 patients in group 1 and 14 (47%) of 30 patients in group 2 (P < .001). Seventeen (61%) of the 28 women in group 1 who aborted did so the same day as misoprostol administration; vaginal bleeding lasted a mean (+/- SD) of 10 (+/- 4) days, and beta-hCG level was less than or equal to 10 IU/L by a mean of 31 (+/- 6) days after methotrexate administration. The 11 other women in group 1 who aborted did so after a mean delay of 29 (+/- 11) days; vaginal bleeding lasted 7 (+/- 4) days, and beta-hCG level was less than or equal to 10 IU/L by a mean of 24 (+/- 11) days after the abortion. There were three treatment failures in group 1: two ongoing pregnancies (6%) and one incomplete abortion (3%). For the 14 women with successful abortions in group 2, vaginal bleeding lasted a mean of 10 (+/- 6) days and beta-hCG level was less than or equal to 10 IU/L by mean of 39 (+/- 18) days after the misoprostol. There were 16 treatment failures in group 2: eight ongoing pregnancies (27%), and eight incomplete abortions (27%). Methotrexate side effects were minimal. Misoprostol side effects were diarrhea in 18% and nausea and vomiting in 5%. CONCLUSIONS: Methotrexate and vaginal misoprostol are more effective than misoprostol alone. Both drugs are available throughout the United States, and both drugs are inexpensive. This combination may offer an alternative to the use of antiprogestin and prostaglandin for medical abortion.

Abortion, Induced↗