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This was despite several study measures to facilitate interval insertion at CHFs. Interval initiation of contraception post-abortion and postpartum is known to be complicated by low adherence, which is a main rationale for quick-start contraception. During the post-pregnancy period women are especially vulnerable to repeat pregnancy and this must be considered in the risk—benefit calculation of immediate and delayed IUD insertion. Immediate insertion of the IUD after medical abortion at 17—20 GW has not to our knowledge been studied.

Our estimated sample size did not accurately predict how many women would not receive an IUD in the immediate group or how many would fail to follow through for delayed insertion. Despite this, findings were statistically significant and loss-to-follow-up lower than predicted. Currently, clinical services have little experience with IUD insertions. Therefore, all relevant staff members received structured mentoring sessions in IUD insertion after medical abortion prior to the study start.

The feasibility of the intervention is being explored in a separate process evaluation. Insertion of an IUD immediately after medical abortion at 17—20 GW results in increased use after 6 weeks, 3 months and 6 months compared with delayed insertion. Expulsion rates are higher than interval insertion and immediate insertion at earlier gestation but similar to immediate insertion after term delivery.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author s and has not been edited for content. Contributors DC was the principal investigator from proposal writing up to final write up. ME was the co-principal investigator from research design up to final write up.

DG participated in study design, analysis, manuscript preparation and editing. GP participated in study execution, manuscript preparation and editing. MP participated in study execution, manuscript preparation and editing. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Skip to main content. Log in via OpenAthens. Log in using your username and password For personal accounts OR managers of institutional accounts. Forgot your log in details? Register a new account? Forgot your user name or password? Search for this keyword. Advanced search. Log in via Institution. You are here Home Archive Volume 48, Issue 1 Immediate versus delayed insertion of the copper intrauterine device after medical abortion at 17—20 gestational weeks: a randomised controlled trial.

Email alerts. Article Text. Article menu. Original research. Immediate versus delayed insertion of the copper intrauterine device after medical abortion at 17—20 gestational weeks: a randomised controlled trial.

Abstract Introduction This trial reports on use of the copper intrauterine device IUD after immediate compared with delayed insertion following medical abortion at 17—20 gestational weeks GW. Data availability statement Data are available upon reasonable request. Statistics from Altmetric. Introduction Globally there is a continued high unmet need for contraception. Data capture and hierarchy We recorded outcome data from ultrasound records, follow-up interviews, and paper and electronic medical records from CHFs for the whole Cape Town Metropolitan area.

The treating clinicians performed the diagnostic tests according to their clinical judgment. Prespecified safety outcomes included an increase in liver enzyme levels defined as more than three times the upper limit of normal and new clinically diagnosed myopathy, as identified by treating clinicians.

A clinical events committee blinded to treatment assignment adjudicated all clinical efficacy and safety outcomes. The supplementary appendix provides additional details about the definitions of the outcomes also see table 2. Patients who were discharged alive from the hospital received regular weekly telephone follow-up. To avoid type I error inflation, it was prespecified to not conduct interim analyses to test the superior efficacy of atorvastatin versus placebo.

Patients enrolled between 29 July and 19 November were considered for eligibility to be randomized to anticoagulation, followed by randomization to statin treatment.

Therefore, the study protocol prespecified that if resources allowed and the study investigators agreed to collaborate, enrollment for the statin randomization could be continued after completion of enrollment for the anticoagulation hypothesis ie, randomization to intermediate dose prophylactic anticoagulation versus standard dose prophylactic anticoagulation.

To maintain harmony with eligibility criteria, the steering committee used the same eligibility criteria including the anticoagulation hypothesis eligibility criteria for patients who would be considered only for the statin randomization.

By the time randomization of patients was completed for the anticoagulation study, were assigned to atorvastatin or to placebo. Considering an actual pooled event rate of Therefore, enrollment for only the statin randomization was planned to continue from 20 November On 4 April the steering committee terminated enrollment owing to the lack of additional funding and the excessive burden of new enrollment to site investigators. By that time, patients were randomized to receive atorvastatin or placebo.

The primary analysis population consisted of randomized patients who received at least one dose of the study drug atorvastatin or placebo , were not excluded, and did not withdraw consent. Additional analyses were performed among all randomized patients and in the per protocol efficacy cohort that included only those patients who completed the treatment as originally allocated until reaching the primary endpoint or the end of 30 day follow-up, whichever occurred first. Assessment of the primary outcome was performed through generalized linear mixed models accounting for the enrolling site as a random effect, the assigned treatment as the exposure variable, and odds ratio as the main effect measure.

The conditional distribution of the primary endpoint given the random effects was assumed to be Bernoulli, with success probability determined by the logistic cumulative distribution function.

In a supplementary analysis, results were assessed in generalized linear mixed models accounting for the enrolling site as a random effect, the assigned treatment as the exposure variable, and hazard ratio as the effect measure. The proportionality assumption was tested by the Schoenfeld residuals, which did not indicate violation of the assumption.

Time to event was shown with Kaplan-Meier curves. Sensitivity analyses were performed with inclusion of all randomized patients meeting the eligibility criteria, and also in the per protocol cohort, consisting of patients who received the assigned treatment until completion of 30 day follow-up or who met the primary efficacy outcome. All clinical outcomes were available for assessment in all patients and no outcome values were missing. Since none of the baseline characteristics met these criteria, multiple imputations were not used for the study variables.

No adjustment was planned for the P value thresholds for multiplicity of comparisons. Therefore, owing to the potential for type 1 error, results from analyses other than the primary efficacy outcome should be considered exploratory. Statistical analyses were performed using R statistical package, version 4.

In the context of the pandemic and the need to design the study in a short period, no patients were involved in setting the research questions or the outcome measures, nor were they involved in developing plans for recruitment, design, or implementation of the study.

No patients were asked to advise on interpretation or writing up of results. The study results and the manuscript were shown to a few members of the public after submission of the manuscript. A total of patients were screened for eligibility between 29 July and 4 April , of whom were enrolled and randomized: assigned to atorvastatin and assigned to placebo. After the exclusion of 14 patients who did not meet the eligibility criteria and four who did not receive at least one dose of the study drugs, entered the prespecified primary analysis population: assigned to atorvastatin and assigned to placebo fig 1.

No losses to follow-up occurred and no values were missing for clinical outcomes. Study flow diagram. Of randomized patients, met the criteria to be considered in the prespecified primary analysis. Table 1 summarizes the baseline characteristics of the two groups. Baseline characteristics of participants assigned to atorvastatin or to placebo in prespecified primary analysis population.

Supplementary table S3 summarizes the reasons for post-randomization changes to the assigned treatments. No patient was treated with extracorporeal membrane oxygenation. Time to event for the primary outcome, a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or all cause mortality during 30 days from randomization, in the prespecified primary cohort, consisting of patients who received at least one dose of the study drug, were not excluded, and did not withdraw consent.

These tests included 17 computed tomography pulmonary angiograms in each group, and 40 venous doppler studies in the atorvastatin group and 41 in the placebo group supplementary table S4. Adjudicated type I myocardial infarction was not clinically diagnosed in either group. The median length of ICU stay was 5 days interquartile range days in the atorvastatin group and 5 days in the placebo group. Table 2 summarizes the results of efficacy and safety outcomes in the two groups.

Thirty day outcomes in prespecified primary analysis population. Values are numbers percentages unless stated otherwise. Table 2 reports additional safety outcomes. Findings were consistent in most of the prespecified subgroups, including in women and men, those with or without obesity, and those with or without diabetes fig 3.

In a prespecified subgroup analysis, use of atorvastatin compared with placebo was associated with lower odds of the primary efficacy outcome among patients with symptom onset within seven days of hospital admission 0. Effect of atorvastatin in prespecified subgroups.

The x axis is on a log scale. Results from sensitivity analyses including all randomized patients and all randomized patients who met the eligibility criteria yielded similar results to those of the primary analysis supplementary tables S8 and S9. Findings were similar when hazard ratio was used as the effect measure.

In this study of adults with covid admitted to the ICU, use of atorvastatin 20 mg once daily compared with placebo was not associated with a significantly reduced odds of the primary outcome, a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or all cause mortality. Findings were consistent for several additional outcomes, including mortality and venous thromboembolism, and in study subgroups and sensitivity analyses.

The current trial does not support a large 30 day benefit from statin treatment in patients with covid admitted to the ICU. Despite adjustments for sample size estimates midway during the trial, the event rates were ultimately lower than expected and we cannot exclude a smaller treatment effect. These findings can be explained in several ways. First, it is possible that statin treatment in this study had a small protective role, which was not detected. Despite our re-estimation of the sample size, the primary efficacy outcome event rate was lower than expected.

This issue might have been multifactorial, including more frequent use of corticosteroids, 31 better general care in the ICU, and lower acuity of illness in some patients. Participants: 92 aircraft passengers aged 18 and over were screened for participation. Intervention: Jumping from an aircraft airplane or helicopter with a parachute versus an empty backpack unblinded.

Main outcome measures: Composite of death or major traumatic injury defined by an Injury Severity Score over 15 upon impact with the ground measured immediately after landing. And common sense matters too. Cardiologist Robert W. Yeh, M. Their study was small, involving just 23 brave or crazy volunteers from the 92 aircraft passengers they invited to participate.