Sam Ononge

Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014

BackgroundIn a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design’s perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design.MethodsWe searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy.ResultsOur review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being ‘instruction on how to perform a behaviour’ (n = 32) and ‘persuasive source’ (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size.ConclusionsThe popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis.

Effectiveness and safety of misoprostol distributed to antenatal women to prevent postpartum haemorrhage after child-births: a stepped-wedge cluster-randomized trial

BackgroundOral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH.MethodsBetween February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by ≥ 2g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant.Results97 % (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271 (13.2 %) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4 % vs intervention 91.4 %, mean difference = -11.0 %, 95 % confidence interval [CI] -25.7 % to 3.6 %, p = 0.11). No woman took misoprostol before their baby’s birth. Shivering and fever were 14.9 % in the control arm compared to 22.2 % in the intervention arm (mean difference = -7.2 %, 95 % CI -11.1 % to -3.7 %), p = 0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop ≥ 2g/dl from 18.5% in the control arm to 11.4 % in the intervention arm (mean difference = 7.1 %, 95 % CI -3.1 % to 17.3 %, p = 0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6 % vs intervention 14.5 %, mean difference -4.9; 95 % CI -12.7 to 2.9), p = 0.17).ConclusionThis study was unable to detect a significant reduction in PPH following the antenatal distribution of misoprostol.The study was registered with Pan-African Clinical Trials Network (PACTR201303000459148, on 19/11/2012).

PL.03 Self-Administration of Misoprostol to Prevent Bleeding After Homebirths in Uganda: A Pilot Placebo-Controlled, Randomised Trial

Objective To pilot a study of self-administered misoprostol after home delivery for postpartum haemorrhage (PPH) prevention. Design A pilot placebo-controlled, double-blind randomised trial Participants Pregnant women at least 34 weeks of gestation living in Mbale district Uganda were recruited at four health facilities. High-risk women and women planning to deliver in facilities were included. Intervention Pregnant women attending the clinics over a 2-month period were randomised to receive either misoprostol (600 µg) or identical placebo to be self-administered orally only if they did not reach a facility for delivery. Each woman was trained on medication use and the importance of PPH. After delivery, the women were visited at home and outcome and safety data collected. Results 748 women were randomised to either 600 µg misoprostol (n = 374) or placebo (n = 374). 93% of women were followed up and 80% of drug packets (both used and unused) were retrieved. 56.7% of women took the study medication. Medication was taken before delivery in 2 women (both in the misoprostol group) and no harm was reported. The primary outcome (fall in Hb >20%) occurred in 7.3% of recruits. There were no significant differences between the groups in the rate of postnatal anaemia or self-reported blood loss. There was significantly more self-reported fever and shivering in the misoprostol group but acceptability of side effects was high. Conclusion A randomised trial of self-administered misoprostol is feasible, and the pilot did not reveal major safety concerns with advanced distribution of misoprostol for self-administration.

Predictors of unknown HIV serostatus at the time of labor and delivery in Kampala, Uganda

To determine factors associated with an unknown HIV serostatus among pregnant women admitted in labor to Mulago Hospital, Kampala, Uganda.