52 research outputs found
Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.
BACKGROUND: The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. METHODS: Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. RESULTS: Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2Â years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1Â year of randomization. CONCLUSIONS: In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low-resource settings with suboptimal medical records and other challenges. Trial planners should ensure that trial budgets cover sufficient on-site researchers with pre-trial training, and should consider using mobile phone and web-based electronic tools to optimize recruitment and retention. This should lead to greater efficiency and shorter trial durations. TRIAL REGISTRATION: Pan-African Clinical Trials Registry, Registration Number: PACTR201105000267371 . The trial was registered on 6 December 2016
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage
Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.Results: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).Conclusions: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage
Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.Results: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).Conclusions: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery
Quantifiable plasma tenofovir among South African women using daily oral pre-exposure prophylaxis during the ECHO trial
Access to data from the ECHO study may be requested through submission of a research concept to ude.wu@crci. The concept must include the research question, data requested, analytic methods, and steps taken to ensure ethical use of the data. Access will be granted if the concept is evaluated to have scientific merit and if sufficient data protections are in place. As of the time of publication, data access applications are in process with the governing institutional review boards of the ECHO study to make deidentified data publicly available.BACKGROUND :
HIV endpoint–driven clinical trials provide oral pre-exposure prophylaxis (PrEP) as HIV prevention standard of care. We evaluated quantifiable plasma tenofovir among South African women who used oral PrEP during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.
METHODS :
ECHO, a randomized trial conducted in 4 African countries between 2015 and 2018, assessed HIV incidence among HIV-uninfected women, aged 16–35 years, randomized to 1 of 3 contraceptives. Oral PrEP was offered onsite as part of the HIV prevention package at the South African trial sites. We measured tenofovir in plasma samples collected at the final trial visit among women reporting ongoing PrEP use. We used bivariate and multivariate logistical regression to assess demographic and sexual risk factors associated with plasma tenofovir quantification.
RESULTS :
Of 260 women included, 52% were ≤24 years and 22% had Chlamydia trachomatis at enrollment. At PrEP initiation, 68% reported inconsistent/nonuse of condoms. The median duration of PrEP use was 90 days (IQR: 83–104). Tenofovir was quantified in 36% (n = 94) of samples. Women >24 years had twice the odds of having tenofovir quantified vs younger women (OR = 2.12; 95% confidence interval = 1.27 to 3.56). Women who reported inconsistent/nonuse of condoms had lower odds of tenofovir quantification (age-adjusted OR = 0.47; 95% confidence interval = 0.26 to 0.83).
CONCLUSIONS :
Over a third of women initiating PrEP and reporting ongoing use at the final trial visit had evidence of recent drug exposure. Clinical trials may serve as an entry point for PrEP initiation among women at substantial risk for HIV infection with referral to local facilities for ongoing access at trial end.
CLINICAL TRIAL NUMBER :
NCT02550067.The Bill & Melinda Gates Foundation, the American people through the United States Agency for International Development, the Swedish International Development Cooperation Agency, the South Africa Medical Research Council, and the United Nations Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development.http://journals.lww.com/jaidshj2023Family MedicineMedical Microbiolog
Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia : a multicentre, double-blind, randomised, placebo-controlled trial
CITATION: Hofmeyr, G. J., et al. 2019. Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia : a multicentre, double-blind, randomised, placebo-controlled trial. The Lancet, 393(10169):P330-339, doi:10.1016/S0140-6736(18)31818-X.The original publication is available at https://www.thelancet.comBackground: Reducing deaths from hypertensive disorders of pregnancy is a global priority. Low dietary calcium
might account for the high prevalence of pre-eclampsia and eclampsia in low-income countries. Calcium
supplementation in the second half of pregnancy is known to reduce the serious consequences of pre-eclampsia;
however, the effect of calcium supplementation during placentation is not known. We aimed to test the hypothesis
that calcium supplementation before and in early pregnancy (up to 20 weeks’ gestation) prevents the development
of pre-eclampsia
Methods: We did a multicountry, parallel arm, double-blind, randomised, placebo-controlled trial in South Africa,
Zimbabwe, and Argentina. Participants with previous pre-eclampsia and eclampsia received 500 mg calcium or
placebo daily from enrolment prepregnancy until 20 weeks’ gestation. Participants were parous women whose most
recent pregnancy had been complicated by pre-eclampsia or eclampsia and who were intending to become pregnant.
All participants received unblinded calcium 1·5 g daily after 20 weeks’ gestation. The allocation sequence (1:1 ratio)
used computer-generated random numbers in balanced blocks of variable size. The primary outcome was
pre-eclampsia, defined as gestational hypertension and proteinuria. The trial is registered with the Pan-African
Clinical Trials Registry, number PACTR201105000267371. The trial closed on Oct 31, 2017.
Findings: Between July 12, 2011, and Sept 8, 2016, we randomly allocated 1355 women to receive calcium or placebo;
331 of 678 participants in the calcium group versus 320 of 677 in the placebo group became pregnant, and 298 of
678 versus 283 of 677 had pregnancies beyond 20 weeks’ gestation. Pre-eclampsia occurred in 69 (23%) of
296 participants in the calcium group versus 82 (29%) of 283 participants in the placebo group with pregnancies
beyond 20 weeks’ gestation (risk ratio [RR] 0·80, 95% CI 0·61–1·06; p=0·121). For participants with compliance
of more than 80% from the last visit before pregnancy to 20 weeks’ gestation, the pre-eclampsia risk was 30 (21%)
of 144 versus 47 (32%) of 149 (RR 0·66, CI 0·44–0·98; p=0·037). There were no serious adverse effects of
calcium reported.
Interpretation: Calcium supplementation that commenced before pregnancy until 20 weeks’ gestation, compared with
placebo, did not show a significant reduction in recurrent pre-eclampsia. As the trial was powered to detect a large
effect size, we cannot rule out a small to moderate effect of this intervention.
ernal and Child Health.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31818-X/fulltextPublisher's versio
High levels of pretreatment HIV-1 drug resistance mutations among South African women who acquired HIV during a prospective study
Access to data from the ECHO Study may be requested through submission of a research concept to [email protected]. The concept must include the research question, data requested, analytic methods, and steps taken to ensure ethical use of the data. Access will be granted if the concept is evaluated to have scientific merit and if sufficient data protections are in place. As of the time of publication, data access applications are in process with the governing institutional review boards of the ECHO Study to make de-identified data publicly available.BACKGROUND : Pretreatment HIV drug resistance (PDR) undermines individual treatment success and threatens the achievement of UNAIDS 95-95-95 targets. In many African countries, limited data are available on PDR as detection of recent HIV infection is uncommon and access to resistance testing is limited. We describe the prevalence of PDR among South African women with recent HIV infection from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.
METHODS : HIV-uninfected, sexually active women, aged 18–35 years, and seeking contraception were enrolled in the ECHO Trial at sites in South Africa, from 2015 to 2018. HIV testing was done at trial entry and repeated quarterly. We tested stored plasma samples collected at HIV diagnosis from women who seroconverted during follow-up and had a viral load >1000 copies/mL for antiretroviral resistant mutations using a validated laboratory-developed population genotyping assay, which sequences the full protease and reverse transcriptase regions. Mutation profiles were determined using the Stanford Drug Resistance Database.
RESULTS : We sequenced 275 samples. The median age was 23 years, and majority (98.9%, n = 272) were infected with HIV-1 subtype C. The prevalence of surveillance drug resistance mutations (SDRMs) was 13.5% (n = 37). Nonnucleoside reverse transcriptase inhibitor (NNRTI) mutations were found in 12.4% of women (n = 34). Few women had NRTI (1.8%, n = 5) and protease inhibitor (1.1%, n = 3) mutations. Five women had multiple NRTI and NNRTI SDRMs.
CONCLUSIONS : The high levels of PDR, particularly to NNRTIs, strongly support the recent change to the South African national HIV treatment guidelines to transition to a first-line drug regimen that excludes NNRTIs.The Bill & Melinda Gates Foundation, the American people through the United States Agency for International Development, the Swedish International Development Cooperation Agency, the South Africa Medical Research Council, and the United Nations Population Fund.http://journals.lww.com/jaidshj2023Family MedicineMedical Microbiolog
Effects of the copper intrauterine device versus injectable progestin contraception on pregnancy rates and method discontinuation among women attending termination of pregnancy services in South Africa: a pragmatic randomized controlled trial
Intervenções obstétricas durante o trabalho de parto e parto em mulheres brasileiras de risco habitual
Factors associated with cesarean delivery during labor in primiparous women assisted in the Brazilian Public Health System: data from a National Survey
Downe S, Gyte GML, Dahlen HG, Singata M. 2013 Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term. Cochrane Database of Systematic Reviews Issue 7. Art. No.: CD010088. DOI: 10.1002/14651858.CD010088.pub2.
Background:
Vaginal examinations have become a routine intervention in labour as a means of assessing labour progress. Used at regular intervals, either alone or as a component of the partogram (a pre-printed form providing a pictorial overview of the progress of labour), the aim is to assess if labour is progressing physiologically, and to provide an early warning of slow progress. Abnormally slow progress can be a sign of labour dystocia, which is associated with maternal and fetal morbidity and mortality, particularly in low-income countries where appropriate interventions cannot easily be accessed. However, over-diagnosis of dystocia can lead to iatrogenic morbidity from unnecessary intervention (e.g. operative vaginal birth or caesarean section). It is, therefore, important to establish whether or not the routine use of vaginal examinations is an effective intervention, both as a diagnostic tool for true labour dystocia, and as an accurate measure of physiological labour progress.
Objectives:
To compare the effectiveness, acceptability and consequences of digital vaginal examination(s) (alone or within the context of the partogram) with other strategies, or different timings, to assess progress during labour at term.
Search strategy:
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2013) and reference lists of identified studies.
Selection criteria:
We included randomised controlled trials (RCTs) of vaginal examinations (including digital assessment of the consistency of the cervix, and the degree of dilation and position of the opening of the uterus (cervical os); and position and station of the fetal presenting part, with or without abdominal palpation) compared with other ways of assessing progress of labour. We also included studies assessing different timings of vaginal examinations. We excluded quasi-RCTs and cross-over trials. We also excluded trials with a primary focus on assessing progress of labour using the partogram (of which vaginal examinations is one component) as this is covered by another Cochrane review. However, studies where vaginal examinations were used within the context of the partogram were included if the studies were randomised according to the vaginal examination component.
Data collection and analysis:
Three review authors assessed the studies for inclusion in the review. Two authors undertook independent data extraction and assessed the risk of bias of each included study. A third review author also checked data extraction and risk of bias. Data entry was checked.
Main results:
We found two studies that met our inclusion criteria but they were of unclear quality. One study, involving 307 women, compared vaginal examinations with rectal examinations, and the other study, involving 150 women, compared two-hourly with four-hourly vaginal examinations. Both studies were of unclear quality in terms of risk of selection bias, and the study comparing the timing of the vaginal examinations excluded 27% (two hourly) to 28% (four hourly) of women after randomisation because they no longer met the inclusion criteria.
When comparing routine vaginal examinations with routine rectal examinations to assess the progress of labour, we identified no difference in neonatal infections requiring antibiotics (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.01 to 8.07, one study, 307 infants). There were no data on the other primary outcomes of length of labour, maternal infections requiring antibiotics and women's overall views of labour. The study did show that significantly fewer women reported that vaginal examination was very uncomfortable compared with rectal examinations (RR 0.42, 95% CI 0.25 to 0.70, one study, 303 women). We identified no difference in the secondary outcomes of augmentation, caesarean section, spontaneous vaginal birth, operative vaginal birth, perinatal mortality and admission to neonatal intensive care.
Comparing two-hourly vaginal examinations with four-hourly vaginal examinations in labour, we found no difference in length of labour (mean difference in minutes (MD) -6.00, 95% CI -88.70 to 76.70, one study, 109 women). There were no data on the other primary outcomes of maternal or neonatal infections requiring antibiotics, and women's overall views of labour. We identified no difference in the secondary outcomes of augmentation, epidural for pain relief, caesarean section, spontaneous vaginal birth and operative vaginal birth.
Authors' conclusions:
On the basis of women's preferences, vaginal examination seems to be preferred to rectal examination. For all other outcomes, we found no evidence to support or reject the use of routine vaginal examinations in labour to improve outcomes for women and babies. The two studies included in the review were both small, and carried out in high-income countries in the 1990s. It is surprising that there is such a widespread use of this intervention without good evidence of effectiveness, particularly considering the sensitivity of the procedure for the women receiving it, and the potential for adverse consequences in some settings.
The effectiveness of the use and timing of routine vaginal examinations in labour, and other ways of assessing progress in labour, including maternal behavioural cues, should be the focus of new research as a matter of urgency. Women's views of ways of assessing labour progress should be given high priority in any future research in this area.
- See more at: http://summaries.cochrane.org/CD010088/routine-vaginal-examinations-in-labour#sthash.GxLr9JRa.dpu
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