Gamble 2010.

Methods	Design: RCT
Participants	Setting: 4 hospital‐based antenatal clinics Type of trauma exposure: women with traumatic birth/EmCS. Inclusion criteria: women in third trimester of pregnancy expecting a full term, normal birth, able to understand sufficient English to discuss their experiences meeting DSM‐IV criterion A for PTSD. Exclusion criteria: pre‐existing mental illness, or expecting an adverse birth outcome. Sample size: 890 women screened for inclusion and 262 randomised Mean age: 30 (SD not specified) years Gender: 262 (100%) women Ethnicity: not specified Country: Australia
Interventions	Group 1: PRIME: n = 137 PRIME refers to a treatment condition for distressed postpartum women. Counselling was delivered at 72 hours after birth in person and at 6 weeks' postpartum by telephone. PRIME aims to support the expression of feelings and provide a framework for women to identify and work through distressing elements of childbirth (Gamble 2009). Women were provided with an opportunity to review the birth and gain a realistic perception of events. Focussed on developing individual situational supports for the present and near future, affirming negative things can be managed and developing a simple plan for achieving this. Group 2: parenting support: n = 125) Support focused on parenting concerns at 72 hours after birth and 6 weeks' postpartum by telephone. Midwives provided information on managing crying, feeding, sleeping and other parenting issues. Both intervention were delivered in 2 sessions at 72 hours' and 6 weeks' postpartum by telephone. Group 3: control: n = 138 Matched control group who were not traumatised were matched for age, parity and education. This group received standard maternity care as provided by their nominated facility. We have not included data from this group.
Outcomes	PTSD: PDS Other: EPDS; DASS; HRQoL; mother–child relationship; parenting satisfaction; sense of competence; parenting stress Follow‐up: 6 weeks', 6 months', 12 months' postpartum
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Mothers screening positive were randomly allocated using computer‐generated numbers.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Analysis based on responses available at each follow‐up point. Proportion of experimental group available at 6 and 12 months lower than control group.
Selective reporting (reporting bias)	Low risk	Outcomes reported as specified in protocol.
Other bias	High risk	Numerically, more participants indicating they received previous mental health help were in PRIME (40%) compared to the parenting group (29%; P = 0.054). No indication that this was controlled for in analyses.