Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial

Table 1 Schedule of enrolment, interventions and assessments

		Study period
			Post-allocation				Close-out
	Enrolment	Allocation	Time periods after injection			1–14 days post birth	From perinatal database
TIMEPOINT**	Enrolment	Allocation	30 min	60 min	90 min	1–14 days post birth	From perinatal database
ENROLMENT:
Eligibility screening	X	X
Signed consent form	X
Randomisation		X
INTERVENTIONS:
*Sterile water injection*		X
*Normal Saline placebo injection*		X
*Vapocoolant spray*		X
ASSESSMENTS:
*Cervical dilation*		X
*VAS of labour pain prior to injections*		X
*VAS of injection pain*		X
*VAS of labour pain post injection*			X	X	X
*At least 30% reduction in VAS of pain*			X
*At least 50% reduction in VAS of pain*			X
*Pharmacological analgesia use*		X					X
*Non-pharmacological analgesia use*		X					X
*Duration of labour*							X
*Augmentation of labour*							X
*Mode of birth*							X
*Estimated blood loss at birth*							X
*Apgar scores*							X
*Type of neonatal resuscitation*							X
*Admission to nursery*							X
*Duration of hospital stay*							X
*Breastfeeding at discharge*							X
*Postnatal survey*						X
*Economic analysis*							X

ISSN: 1745-6215