Effects of phloroglucinol on the active phase of labour (EPAL trial): a single blinded randomised controlled trial in a tertiary hospital in sub-Sahara Africa

Abstract

Introduction: one of the most recognized factors of maternal and neonatal outcome pertaining to the peripartum period is the duration of labour. Finding a drug that will decrease the duration of labour with no effects on mother and foetus will be welcomed. Thereby in this study we aimed to evaluate the effects of phloroglucinol on the duration of the active phase of labour.

Methods: we did a single blinded placebo controlled randomised 1:1 parallel designed superiority trial between January and June 2017 in Douala general hospital. Participants greater than 18 years with singleton uncomplicated pregnancy who consented following randomisation, were administered either 80mg/8ml intravenous phloroglucinol or 8ml of sterile water when in active labour. The primary outcome was the duration of labour. Modified intention to treat analysis was done with the level of significance set at a p value of 0.05.

Results: 122 participants received the intervention. The mean total duration labour in the treatment and placebo group were 216.8 ± 38.7 and 358.5 ± 65.8 respectively (p value = 0.243). The mean duration of the active phase of labour in the treatment and placebo group were 183.0±35.6 and 316.0±52.2 respectively (p value = 0.046). The mean rate of cervical dilatation in the treatment and placebo group were 2.1 ± 0.4 and 1.3 ± 0.4 respectively (p value = 0.322). There was no difference in maternal and foetal outcomes between the two groups.

Conclusion: phloroglucinol shortens the duration of active phase of labour by about 2 hours (42%). It is safe to mother and baby and does not cause adverse foetal or maternal outcomes.