Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial

BACKGROUND: Prolonged latent phase of labour often results in a traumatic birth experience. Prolonged labour is associated with more operative deliveries, haemorrhage, fetal asphyxia and poor birth experience. Women with prolonged labour in a former pregnancy more often demand caesarean section in the next, due to their negative birth experience. “Proactive support of labour” is an alternative method, developed to counteract prolonged labour. There are little research and no randomized controlled study that compare proactive to standard labour support. METHODS/DESIGN: A prospective, non-blinded, randomized, single-centre, clinical trial where we compare proactive support to standard support of labour in a university hospital setting. Inclusion criteria: latent phase of labour, non-pathologic pregnancy. Robson group 1, with painful contractions, and fully effaced cervix, with 1–3 cm dilatation. Exclusion criteria: induction of labour, breech presentation, twin pregnancy, multi-parity, conditions that require extended surveillance before and/or during labour. Primary outcome: spontaneous, uncomplicated vaginal delivery. After inclusion, women randomized to proactive support of labour will stay at the hospital and have one-to-one midwife support. If no progression during the next 1–2 hours, amniotomy and/or oxytocin stimulation will be started. The control group will adhere to the standard procedures for labour support: expectance until established regular contractions and 4–5 cm cervical dilatation, and then one-to-one midwife support. DISCUSSION: The idea of proactive support of labour is to initiate early intervention when there are signs of slow progress in order to avoid protracted labour with exhaustion of the mother, the uterus and prolonged stress of the foetus. Proactive support of labour may represent a useful method to improve labour support in nulliparous women. However, evidence based on randomized controlled trials are needed in order to know whether proactive support of labour is comparable or superior to standard care. A randomized, controlled trial is described; challenges and possible clinical implications are discussed. TRIAL REGISTRATION: The Proactive Support of Labor Study (PAF) ClinicalTrials, NCT03056313. Registered on February 17, 2017.