The project summary (sometimes called the abstract) should give the
reader a clear description of the central question that the research
intends to answer
and why the question is important. In addition, the summary
briefly describe the methods and procedures to be used in the
trial. The clinical, health services delivery, or health policy
significance of the
expected results should also be mentioned in the summary.
If you are writing a protocol for a particular funding body then the length of the summary may well be limited to 250-1000 words. Even if there is no fixed word limit, it is best to keep the summary short and succinct. It is worth noting that the only review panel members to read the entire proposal document are often those specifically responsible for a particular application. Most members read ONLY the summary. This makes it crucial that it is written both clearly and comprehensively.
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‘Hypertensive disorders of pregnancy (HDP) affect
10% of all pregnancies. The aetiology and pathophysiology of HDP are
largely unknown and an ideal prevention and treatment strategy does not
Although there has been progress in perinatal survival, largely due to
developments in care of small babies, HDP continue to be major
contributors to maternal and perinatal morbidity and mortality,
especially in developing countries. The systematic review of randomized
controlled trials of calcium supplementation provides promising
evidence that calcium supplementation may be effective in preventing
HDP in women with low calcium intake. It is important to obtain a
reliable, definitive answer to this question for both clinical and
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Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. The goal of this project is to develop and evaluate an intervention intended to implement evidence-based practices among birth attendants in Latin America.
The aim of this project is to perform a cluster randomized controlled trial of a behavioral intervention in Argentina and Uruguay that will increase the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor. The intervention will be based on the stages of change and organizational change theories and tailored by formative research that will include baseline questionnaires and focus groups.
Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop evidence-based guidelines. They will then diffuse the guidelines by using a multifaceted approach including seminars, academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the nonintervention group will continue with their standard in-service training activities. The main outcomes to be assessed are the use of episiotomies and of oxytocin during the third stage of labor. Secondary outcomes will be perineal sutures, potspartum hemorrhages, and birth attendants’ opinions.
The Latin American Center for Perinatology (CLAP) will be the coordinating center for the trial. In this way, the project endeavors to facilitate capacity building of CLAP and its network of hospitals to perform studies integrating behavioral and clinical research methods. It is also anticipated that the project will contribute to the Global Network by increasing access to a large number of Latin American hospitals that have the capacity to participate in multicentric randomized controlled trials and other clinical studies’ (CLAP Trial - go to protocol)
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CRASH is a large simple, placebo controlled trial of the effects of a 48-hour infusion of corticosteroids on death and on neurological disability, among adults with head injury and some impairment of consciousness. Head injured patients with impaired consciousness who are judged to be 16 years or older are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use corticosteroids. Numbered drug or placebo packs will be available in each participating emergency department. Randomisation involves calling a 24-hour freephone service. The call should last only a minute or two, and at the end of it the service will specify to the caller which numbered treatment pack to use. The drug or placebo in the pack is made up in saline and, following a one-hour loading dose, is infused over 48 hours (or as close to 48 hours as possible). No extra tests are required, but a short form is to be completed two weeks later (or after prior death or discharge). Long term recovery will be assessed at six months either by a simple questionnaire, sent directly to each trial participant from the CRASH Co-ordinating Centre, or by telephone interview. This does not involve any additional work for collaborating hospitals. ( CRASH Trial - go to protocol)
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