Journal club papers
- This study was a blinded, randomised controlled trial performed across 27 obstetric units in the UK.
- 3,427 women who had an operative vaginal birth >36 weeks gestation were randomly assigned to single-dose IV amoxicillin and clavulanic acid within 6 hours of birth vs placebo.
- 77% were primiparous; 49% had an induction of labour; 65% had a forceps birth and 35% a vacuum and 89% of women had an episiotomy.
- The primary outcome was confirmed or suspected maternal infection within 6 weeks of delivery (defined by a new prescription of antibiotics, confirmed systemic infection on culture or a diagnosis of endometritis).
- Overall, 15% of women experienced the primary outcome.
A single injection of IV amoxicillin and clavulanic acid reduced the risk of infection by 42% (RR 0.58; 95%CI 0.49-0.69). Importantly, antibiotic treatment reduced the risk of serious systemic infection by 56% (RR 0.44; 95%CI 0.22-0.89).
- Women who received antibiotics were also significantly less likely to 1) experience perineal pain and/or wound breakdown at 6 weeks post-partum and 2) report that their perineum was too uncomfortable to feed their baby.
- Adverse reactions (skin rash) were reported by one patient in the placebo group and two in the treatment group.
Take home message: Give a single dose of IV amoxicillin and clavulanic acid soon after an instrumental birth. It seems to reduce clinically significant infections. The risk reduction is also pretty impressive.
RANZCOG now advocates this - RANZCOG Instrumental Vaginal Birth Guidelines
- A randomised, double blinded placebo-control trial of sildenafil citrate (50mg every 8 hours - max 3 doses) to reduce emergency operative birth (caesarean section or instrumental vaginal birth) for fetal distress.
- 300 women with a singleton pregnancy in cephalic presentation after 37 weeks gestation were randomized (1:1) in early labour (<4 cm dilated) or during planned induction of labour.
- Sildenafil citrate reduced the risk of operative birth for fetal distress by 51% (18.0% vs 36.7%; RR 0.49 [95% CI 0.33 - 0.73]).
- Sildenafil citrate reduced the risk of the composite secondary outcome of meconium stained liquor or pathological fetal heart rate patterns by 43%.
- The levels of sildenafil citrate and its metabolite in cord blood were very low.
You may have heard bad press on trials of sildenafil to treat preterm fetal growth restriction, one of which was stopped early due to a possible increased incidence of pulmonary hypertension in the newborns (STRIDER trials). However, the dose and frequency of sildenafil used in this study was lower than that used in the STRIDER trials. Also, this was an intrapartum study where only a few doses were given.
Although these findings are promising and suggest sildenafil citrate may reduce operative delivery due to fetal distress, the findings need validation before we stock the birth suite with Viagra.
- A randomized double-blinded placebo-controlled trial of hydroxychloroquine prophylaxis following household or occupational exposure to someone with confirmed COVID-19 infection.
- Within 4 days of initial exposure, participants were randomised to placebo or hydroxychloroquine (800 mg once, 600 mg within 6-8 hours and 600 mg daily for 4 days) and the incidence laboratory confirmed or illness compatible with COVID-19 infection assessed.
- Among 821 participants, the incidence of suspected or confirmed COVID-19 infection did not differ between the hydroxychloroquine and placebo groups (12% and 14%, respectively). One participant was hospitalized in each group.
- Side effects were more commonly reported in the hydroxychloroquine group, mainly nausea, loose stools and abdominal discomfort (40.1% vs 16.8). However, there were no deaths, serious adverse events or cardiac arrhythmias.
These findings suggest hydroxychloroquine does not prevent symptomatic COVID-19 infection. However, given not all participants were tested for laboratory confirmed infection we cannot be certain how many participants actually developed COVID-19 infection.
Importantly, hydroxychloroquine was not associated with harm. However, we must note that patients were either not infected or asymptomatic at the time of treatment, thus the safety of hydroxychloroquine in treating symptomatic or hospitalized COVD-19 infection remains unclear.
We hope that the now resumed (after initially halted following the retracted Lancet paper) WHO Solidarity trial testing hydroxychloroquine will finally determine both the efficacy and safety of hydroxychloroquine in treating COVID-19 infection.