Eogan 2007.

Study characteristics
Methods	Study design: randomised controlled trial Trial duration: 12 months (May 2003 to April 2004) Trial location: National Maternity Hospital, Holles St Dublin, Ireland
Participants	Participants: 147 postpartum women with sphincter injury at vaginal delivery, undergoing primary repair of a recognised anal sphincter tear Intervention group: 70 postpartum women Control group: 77 postpartum women Exclusion criteria: history of colorectal disease, inflammatory bowel disease, diabetes mellitus, or colorectal malignancy
Interventions	Intervention: oral lactulose 10 mL thrice daily for the first 3 postpartum days, followed by sufficient lactulose to maintain a soft stool for 10 days, plus 1 sachet of Ispaghula husk for 10 days Control: oral lactulose 10 mL thrice daily for the first 3 postpartum days, followed by sufficient lactulose to maintain a soft stool for 10 days All women were given routine antibiotics (co‐amoxyclavulanic acid); erythromycin and metronidazole were used in those with penicillin allergy All participants were provided with a diary card to keep record of their bowel habits and movements for 10 days Opiate was avoided in both groups
Outcomes	Primary outcomes 1. Discomfort with 1st postpartum bowel motion (using pain scale from 1 = no pain to 5 = excruciating pain) 2. Incidence of postnatal constipation and incontinence Secondary outcomes 1. Time until first bowel motion 2. Duration of postnatal stay 3. Symptomatic and functional outcomes 3 months postpartum All participants were provided with a diary card to keep record of their bowel habits and movements for 10 days; opiate was avoided in both groups
Notes	Funding: the study was supported by the Irish Health research board Correspondence: email was sent to the author (colm.oherlihy@ucd.ie) requesting further information on method used to ensure adequate concealment of the assignment and blinding processes, but there was no response. Dates of study: the study was conducted between May 2003 and April 2004 Funding sources: the study was supported by the Irish Health research board Declarations of interest: not disclosed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was carried out using computer‐generated allocations.
Allocation concealment (selection bias)	Unclear risk	''Sealed opaque envelopes were used to concealed allocation identity''. It was not specified whether the envelopes were sequentially numbered to prevent selection bias.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	There was no explicit information on blinding of the participants, personnel, and investigators to the assignment.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to judge whether the assessors were blinded to the assignment or not
Incomplete outcome data (attrition bias) All outcomes	High risk	All participants attended the first 10 day follow‐up; 26 did not attend postpartum review at 3 months despite 2 repeated appointment‐reminders being sent, 24 of whom gave a personal reason and 2 could not be traced Attrition rate in intervention group (LG) = 16% Attrition rate in control group (FG) = 20%
Selective reporting (reporting bias)	Low risk	All outcomes that were prespecified in the methods were addressed.
Other bias	Low risk	The study appeared to be free of other sources of bias.