Foley catheter vs oral misoprostol for induction of labor: individual participant data meta-analysis.

OBJECTIVE: To compare the effectiveness and safety of Foley catheter and oral misoprostol for induction of labor (IOL). METHODS: The Cochrane Review on Mechanical Methods for Induction of Labour and Ovid MEDLINE, EMBASE via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov and Scopus, from inception to April 2019, were searched for randomized controlled trials (RCTs) comparing Foley catheter to oral misoprostol for IOL in viable singleton gestations. Eligible trials for which raw data were obtained were included and individual participant data meta-analysis was performed. Primary outcomes were vaginal birth, a composite of adverse perinatal outcome (including stillbirth, neonatal death, neonatal seizures, admission to the neonatal intensive care unit, severe respiratory compromise or meconium aspiration syndrome) and a composite of adverse maternal outcome (including admission to the intensive care unit, maternal infection, severe postpartum hemorrhage, maternal death or uterine rupture). The quality of the included RCTs was assessed using the Cochrane Risk of Bias 2 tool and the certainty of evidence was evaluated using the GRADE approach. A two-stage random-effects model was used for meta-analysis according to the intention-to-treat principle and interactions between treatment and baseline characteristics were assessed. RESULTS: Of seven eligible trials, four provided individual participant data for a total of 2815 participants undergoing IOL, of whom 1399 were assigned to Foley catheter and 1416 to oral misoprostol. All four trials provided data for each of the primary outcomes in all 2815 women. Compared with those receiving oral misoprostol, Foley catheter recipients had a slightly decreased chance of vaginal birth (risk ratio (RR), 0.95 (95% CI, 0.91-0.99); I2 , 2.0%; moderate-certainty evidence). A trend towards a lower rate of composite adverse perinatal outcome was found in women undergoing IOL using a Foley catheter compared with oral misoprostol (RR, 0.71 (95% CI, 0.48-1.05); I2 , 14.9%; low-certainty evidence). Composite adverse maternal outcome did not differ between the groups (RR, 1.00 (95% CI, 0.97-1.03); I2 , 0%; moderate-certainty evidence). Meta-analyses of effect modifications did not show significant interactions between intervention and parity or gestational age for any of the primary outcomes. CONCLUSIONS: For women undergoing IOL, Foley catheter is less effective than oral misoprostol, as it was associated with fewer vaginal births. However, while we found no significant difference in maternal safety, Foley catheter induction may reduce adverse perinatal outcomes. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.

Foley catheter vs. oral misoprostol to induce labour among hypertensive women in India: a cost-consequence analysis alongside a clinical trial.

OBJECTIVE: To determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low-resource settings. DESIGN: Cost-consequence analysis of a previously reported multicentre, parallel, open-label randomised trial. SETTING & POPULATION: A total of 602 women with a live fetus, aged ≥18 years requiring delivery for pre-eclampsia or hypertension, in two public hospitals in Nagpur, India. METHODS: We performed a formal economic evaluation alongside the INFORM clinical trial. Women were randomised to receive transcervical Foley catheterisation or oral misoprostol 25 mcg. Healthcare expenditure was calculated using a provider-side microcosting approach. MAIN OUTCOME MEASURES: Rates of vaginal this delivery within 24 hours of induction, healthcare expenditure per completed treatment episode. RESULTS: Induction with oral misoprostol resulted in a (mean difference) $20.6USD reduction in healthcare expenditure [95% CI (-) $123.59 (-) $72.49], and improved achievement of vaginal delivery within 24 hours of induction, mean difference 10% [95% CI (-2 to 17.9%), P = 0.016]. Oxytocin administration time was reduced by 135.3 minutes [95% CI (84.4-186.2 minutes), P < 0.01] and caesarean sections by 9.1% [95% CI (1.1-17%), P = 0.025] for those receiving oral misoprostol. Following probabilistic sensitivity analysis, oral misoprostol was cost-saving in 63% of 5,000 bootstrap replications and achieved superior rates of vaginal delivery, delivery within 24 hours of induction and vaginal delivery within 24 hours of induction in 98.7%, 90.7%, and 99.4% of bootstrap simulations. Based on univariate threshold analysis, the unit price of oral misoprostol 25 mcg could feasibly increase 31-fold from $0.24 to $7.50 per 25 mcg tablet and remain cost-saving. CONCLUSION: Compared to Foley catheterisation for the induction of high-risk hypertensive women, oral misoprostol improves rates of vaginal delivery within 24 hours of induction and may also reduce costs. Additional research performed in other low-resource settings is required to determine their relative cost-effectiveness. TWEETABLE ABSTRACT: Oral misoprostol less costly and more effective than Foley catheter for labour induction in hypertension.

Magnesium sulphate for prevention of eclampsia: are intramuscular and intravenous regimens equivalent? A population pharmacokinetic study.

OBJECTIVE: To compare magnesium sulphate concentrations achieved by intramuscular and intravenous regimens used for the prevention of eclampsia. SETTING: Low-resource obstetric hospitals in Nagpur and Vellore, India. POPULATION: Pregnant women at risk for eclampsia due to hypertensive disease. METHODS: A pharmacokinetic study was performed as part of a randomised trial that enrolled 300 women comparing intramuscular and intravenous maintenance regimens of magnesium dosing. Data from 258 enrolled women were analysed in the pharmacokinetic study. A single sample was drawn per woman with the expectation of using samples in a pooled data analysis. MAIN OUTCOME MEASURES: Pharmacokinetic parameters of magnesium distribution and clearance. RESULTS: Magnesium clearance was estimated to be 48.1 dl/hour, volume of distribution to be 156 dl and intramuscular bioavailability to be 86.2%. The intramuscular regimen produced higher initial serum concentrations, consistent with a substantially larger loading dose. At steady state, magnesium concentrations in the intramuscular and intravenous groups were comparable. With either regimen, a substantial number of women would be expected to have serum concentrations lower than those generally held to be therapeutic. CONCLUSIONS: Clinical implications were that a larger loading dose for the intravenous regimen should be considered; where feasible, individualised dosing of magnesium sulphate would reduce the variability in serum concentrations and might result in more women with clinically effective magnesium concentrations; and lower dose magnesium sulphate regimens should be considered with caution.

OS034. Magnesium sulfate for prevention of eclampsia: Are intramuscularand intravenous regimens equivalent?

INTRODUCTION: Magnesium sulfate is the agent of choice for the treatment and prevention of eclampsia. Optimal loading and maintenance dosing has not been determined. OBJECTIVES: To compare the pharmacokinetic parameters if IM vs. IV magnesium sulfate. METHODS: A pharmacokinetic study was performed as part of a randomized trial that enrolled 300 women comparing IM and IV regimens of magnesium dosing in two low resource sites in India. Data from 258 enrolled women were analyzed in the pharmacokinetic study. Due to infrastructure available at the sites, a single sample was drawn per subject with the expectation of utilizing samples in a pooled data analysis. RESULTS: Magnesium clearance was estimated via pharmacokinetic modeling to be 48.1dL/h, volume of distribution 156dL and IM bioavailability 86.2%. The IM regimen produced higher initial serum concentrations, consistent with a substantially larger loading dose. At steady state, Mg concentrations in the IM and IV Groups were comparable. With either regimen, a substantial number of subjects would be expected to have serum concentrations lower than those generally expected to be therapeutic. CONCLUSION: A larger loading dose for the IV regimen should be considered. Where feasible, individualized higher doses of magnesium sulfate would yield a greater number of treated women with clinically effective magnesium concentrations.

Alternatives to routine ultrasound for eligibility assessment prior to early termination of pregnancy with mifepristone-misoprostol.

OBJECTIVE: To test the feasibility and efficacy of an approach that foregoes the routine use of ultrasound for the determination of eligibility for medical termination of pregnancy. DESIGN: Prospective trial. SETTING: Ten termination of pregnancy clinics in the USA. POPULATION: A total of 4484 women seeking termination of pregnancy with mifepristone-misoprostol. METHODS: Women provided estimates of the date of their last menstrual period and underwent pelvic bimanual and ultrasound examinations. We compared estimates of gestational age using these three methods. MAIN OUTCOME MEASURE: Proportion of women of ≤9 weeks' gestation by woman or provider estimate, but >9 weeks' gestation by ultrasound. RESULTS: The reliance on women's report of their last menstrual period together with physical examination to determine their eligibility for termination of pregnancy with mifepristone-misoprostol would result in few women (63/4008 or 1.6%) accepted for treatment outside the current limits of standard mifepristone-misoprostol regimens used for early termination of pregnancy (i.e. ≤63 days' gestation on ultrasound). CONCLUSIONS: Last menstrual period and physical examination alone, without the routine use of ultrasound, are highly effective for the determination of women's eligibility for early termination of pregnancy with mifepristone-misoprostol.

Are two doses of misoprostol after mifepristone for early abortion better than one?

OBJECTIVE: The objective of this study was to determine if a repeat dose of misoprostol following mifepristone or a single dose of misoprostol increases the efficacy of medical termination of pregnancy. DESIGN: Randomised, placebo controlled trial. SETTING: K.E.M. Hospital, Pune, India, and the Health Centre, Larsen and Toubro Limited, Mumbai, India. SAMPLE: A total of 300 women seeking an abortion with amenorrhoea of 8 weeks or less. Methods Women were randomised to receive one or two doses of 400 microgram oral misoprostol at the clinic 48 hours after administration of 200 mg mifepristone. Main outcome measure Complete abortion without surgical intervention. Results The repeat administration of misoprostol 400 microgram improved the complete abortion rate from 86 to 92% and significantly reduced the rate of continuing pregnancy from 7 to 1%. Almost all the women who were administered the additional dose of misoprostol were either very satisfied (58%) or satisfied (37%) with the method. Conclusion While an additional oral dose of 400 microgram misoprostol did not significantly increase the rate of complete abortion without surgical intervention, the additional dose did significantly reduce the rate of continuing pregnancies without compromising the acceptability and ease of use of the method.

Knowledge and attitudes about abortion legislation and abortion methods among abortion clients in Latvia.

OBJECTIVE: To assess knowledge of abortion legislation and knowledge and attitudes about medical and surgical abortion among women seeking a legal abortion in Latvia. METHODS: Data are drawn from a survey of 371 abortion clients from 16 purposively selected abortion clinics in Latvia. A semi-structured questionnaire was used to collect socio-demographic data and information on women's knowledge of and attitudes toward abortion law and abortion methods. RESULTS: Most women knew that abortion is legal either under any (53%) or certain (37%) circumstances. Almost one third (31%) of women interviewed were aware of medical abortion. After hearing a description of medical abortion, respondents felt the method as described would be advantageous because it could avoid a surgical intervention (33%) or found it simple, easy, convenient, or natural (12%). Women were concerned that the method might not be completely effective (38%) or be associated with side-effects (22%). CONCLUSIONS: Respondents were interested in medical abortion as a less invasive option to surgical abortion. Efforts should be undertaken to inform women about the safety and efficacy of the method.

Experience-based guidelines for the implementation of telemedicine services.

Many telemedicine projects fail to survive beyond the funded research phase. A review of seven Scottish telemedicine services was conducted to identify successes and failures. Qualitative interviews were conducted with key individuals in each project. All projects were partly successful. The main reasons associated with partial failure were: the service was not needs-driven; there was no commitment to provide the service; there was no suitable exit strategy after research funding expired; there was poor communication; there was a lack of training; there were technical problems; work practices were not updated; the protocols for use were poor or non-existent. Based on this, guidelines that might improve the chances of success in future projects were drawn up.

Evaluation of an accident and emergency teleconsultation service for north-east Scotland.

We evaluated an accident and emergency teleconsultation service provided to 14 community hospitals in north-east Scotland. Each community hospital was equipped with a videoconferencing system and a document camera to allow transmission of radiographs. The network used 384 kbit/s ISDN connections. A total of 1392 teleconsultations were recorded during a 12-month study period. Seventy-seven per cent of patients (n = 1072) were managed locally and 23% (n = 320) were transferred to Aberdeen. The majority (95%) of teleconsultations were conducted on weekdays, and 90% of these occurred between the hours of 09:00 and 16:00. The mean delay in contacting a doctor was 9 min and the mean consultation time was 10 min. The majority of patients were suffering from fractures or suspected fractures of the limbs. Radiograph transmission was used in 75% of all teleconsultations. A high degree of satisfaction was recorded by all users of the service.

The importance of setting and evaluating standards of telemedicine training.

The importance of appropriate training in the use of videoconferencing equipment for clinical purposes is often underestimated when telemedicine projects are established. We developed a user training programme which was delivered via videoconferencing to a group of 130 nurses. Training was delivered on a one-to-one basis. A questionnaire was developed to evaluate user satisfaction and the effectiveness of training. One hundred and two fully completed questionnaires were returned (a 79% response rate). High levels of satisfaction were obtained but the level of user competence reached 100% only when training was supported by a training manual and at least weekly practice. Before establishing a telemedicine service, the following steps appear to be important: identify the required training competencies; deliver a 'hands on' training programme based on the required training competencies; back up the training programme with an instruction booklet; ensure that trainees have at least weekly practice; measure the level of user competence.

Evaluation of a pilot telemedicine network for accident and emergency work.

A pilot accident and emergency teleconsulting service was established in Scotland. It was based at the accident and emergency department of the main hospital in Aberdeen. There were three peripheral sites in rural Grampian (Peterhead, Turriff and Huntly) and one in the Shetland Isles. The videoconferencing equipment used was connected by ISDN at 384 kbit/s. During the 15 months of the study, 1998 videoconference calls were made, of which 402 (20%) calls were made to the accident and emergency department for clinical consultations. The majority of the clinical calls (95%) were made between 09:00 and 17:00, and more than 90% were completed within 20 min. During the majority of calls (87%) one or more X-ray images were transmitted. The majority of patients (89%) received treatment without transportation to the main centre in Aberdeen. The present study demonstrated that accident and emergency teleconsultations can be technically reliable, effective in reducing the number of patient transfers and acceptable to the referring clinicians. As a result, approximately 1.5 million has been made available by the government to develop a national system for Scotland.

The development of a pilot telemedicine network in Scotland: lessons learned.

A pilot telemedicine network was established in 11 sites using funding provided by the Department of Trade and Industry in the UK. The main purpose of the project was to develop and evaluate clinical and educational links between central and peripheral sites in Scotland. The results were very encouraging, and clinical services were established in accident and emergency medicine, tele-ultrasound and clinical psychology. An undergraduate medical teaching service was also successfully established. All of these services are to be continued after the completion of the project. Many lessons were learned during the establishment of this network which will be useful in future projects. These included the importance of training for telemedicine users, the importance of identifying a telemedicine champion, the pitfall of health economics and the fact that services must be needs driven.

The diagnostic acceptability of low-bandwidth transmission for tele-ultrasound.

Ultrasound recordings were made of 100 consecutive patients attending for obstetric examination in Peterhead and 100 patients attending for non-obstetric examination in Aberdeen. Two identical video-conferencing machines were used to transmit and receive the original ultrasound images at data rates of 384 kbit/s and 128 kbit/s, thus producing a total of three tapes for each case. Four experienced observers, who were blinded to the transmission bandwidth, each viewed 300 examinations and decided whether the images were acceptable or not for diagnosis. Almost 100% of the obstetric ultrasound images on the original recordings were considered diagnostically acceptable, compared with 93% of the 384 kbit/s transmissions and 44% of the 128 kbit/s transmissions. Similarly, 99% of the non-obstetric ultrasound images were considered acceptable, compared with 87% of the 384 kbit/s transmissions and 21% of the 128 kbit/s transmissions. For the obstetric ultrasound images the intra-observer diagnostic agreement was 93% (kappa = 0.89) between the original and the 384 kbit/s transmissions, and 78% (kappa = 0.63) between the original and the 128 kbit/s transmissions. For the non-obstetric ultrasound images the respective intra-observer diagnostic agreements were 77% (kappa = 0.62) and 78% (kappa = 0.63). The quality of dynamic ultrasound images transmitted at 384 kbit/s was diagnostically acceptable, but was unsatisfactory at 128 kbit/s.

Low-bandwidth tele-ultrasound.

We examined the acceptability and diagnostic accuracy of dynamic ultrasound images transmitted at 128 kbit/s and 384 kbit/s. The gold standard was the direct recording of 200 ultrasound examinations on video-tape. The taped images were later transmitted at both 128 kbit/s and 384 kbit/s and recorded, resulting in three tapes for each case. Four observers viewed each tape individually. Ninety per cent of images transmitted at 384 kbit/s were rated as diagnostically acceptable compared with 32% of images transmitted at 128 kbit/s. Diagnostic agreement between tapes transmitted at 384 kbit/s and the gold standard was 85%, compared with 78% for 128 kbit/s transmissions. Observers were not satisfied with low-bandwidth transmission of ultrasound images despite adequate diagnostic accuracy. Dynamic ultrasound images transmitted at 384 kbit/s were viewed as both diagnostically acceptable and accurate.

International collaboration in the development of postgraduate research training (692).

Research training leading to a higher degree can be difficult for those who live in countries where advanced educational facilities are not yet available, since it may involve translation of a whole family to a foreign country with resultant language, financial and cultural problems. There are special difficulties for females and those of the Moslem faith, who may have been married early and already have a family by the time of initial graduation. There may also be cultural difficulties preventing overseas study for the unmarried female. This paper describes a flexible approach developed by the University of Aberdeen in association with the Ministry of Health in Kuwait. This was an MSc course on the process of continuous quality assurance in medical practice which was based on the concept that research training was the best means of evaluating and measuring quality. The students were finally assessed on the quality of their research dissertation. The course, which was part-time, and thus lasted for 2 years, required them to spend 12 weeks in each of two successive summers in Aberdeen. The subject chosen for each dissertation was related to the work area of the candidate and was studied in the country of origin with the help of periodic visits by the supervisors. The results were surprisingly successful since the students became highly motivated by the problems of their own country and were encouraged by their colleagues at home. The process could have been even more successful if videoconferencing facilities had been available at both the Aberdeen and Kuwait centres. It is concluded that a more flexible approach by western universities would result in an increase in both the quantity and the quality of postgraduate study.

The development of a telemedicine laboratory as a medical faculty resource.

A telemedicine facility was established for the Faculty of Medicine of the University of Aberdeen and developed as a laboratory to help ensure a scientific approach to the implementation of telemedicine. Once a service application has been positively evaluated and established then it should be funded and delivered outside the laboratory, thus freeing up time and resources for the evaluation of new areas. Since it would appear that the practice of telemedicine is here to stay, it would also seem reasonable to suggest that an introduction to telemedicine should be included in the medical undergraduate curriculum.

Intercontinental postmortem studies using interactive television.

For cultural reasons, medical students in the United Arab Emirates (UAE) are not offered postmortem studies. In a collaborative project between the medical schools of Aberdeen University and the UAE University the feasibility, acceptability and effectiveness of telepathology teaching were evaluated. The transmission of postmortem video images at a quality high enough for teaching purposes was achieved at a data transmission speed of 384 kbit/s. Videoconferencing as a method of presentation was viewed by the students as both interesting and useful. All students participating in the telepathology teaching sessions exceeded the minimum acceptable score of 60% in a multiple-choice examination. Although international videoconferencing at 384 kbit/s is expensive, the costs involved in the telepathology project were small in relation to the educational benefits.

A pilot study in medical education using interactive television.

Medical students in the United Arab Emirates do not receive postmortem teaching. This is because postmortems are not normally carried out, for cultural reasons. In order to address this problem a collaborative project was established between the medical schools of Aberdeen University and the United Arab Emirates University to evaluate the feasibility, acceptability and effectiveness of telepathology teaching. A videoconferencing link was established between the UK and the Middle East using ISDN at a transmission speed of 384 kbit/s. Although some technical problems relating to line continuity were encountered, the results relating to feasibility, acceptability and effectiveness were very positive. Although expensive, this form of teaching may still be cost-effective in relation to the benefits.

The nurse practitioner: management of minor trauma.

OBJECTIVE: to identify patient groups within Accident and Emergency (A & E) practice where the nurse practitioner, following agreed protocols and treatment regimes, might make a contribution to patient care; and to describe a possible process of preparation required to introduce nurse practitioners into an A & E department. DESIGN: A 14-day study (6-12 January and 24-30 July 1994) in which the case notes of all patients attending the A & E department were analysed. SETTING: The A & E department of Aberdeen Royal Infirmary, UK. PARTICIPANTS: A census of the case notes of 1785 patients. MAIN OUTCOME MEASURES: Demographic and clinical characteristics of new patients, diagnosis, investigations, treatment ordered, numbers of return visits, source of referrals and disposal destinations. RESULTS: On analyses of the workload profile it became apparent that a small number of injury categories, investigations and treatments, accounted for a significant percentage of patient throughput and that 75% of cases attended between 09:00 and 21:00 h. Many cases were of a minor nature, discharged home after minimal treatment and no follow-up. It was thought possible that the assessment and treatment of a significant percentage of patients (30%) could be carried out by suitably trained and experienced nurses working to an agreed protocol. CONCLUSIONS: The paper discusses the concept of the nurse practitioner and seeks to demonstrate a possible role for such a clinical worker using previously agreed protocols devised from a clinical database of patient requirements. Their employment could possibly bring a considerable routine saving in waiting time for patients with minor injuries.