Rouhe 2015.

Study characteristics
Methods	A randomised controlled trial.
Participants	Setting: Gynaecology and Obstetrics, Otology, Ophthalmology, Neurology and Neurosurgery of Helsinki University Central Hospital. Routine ultrasonography screening at the gestational age of 11–13 weeks. Inclusion criteria: those who scored > 100 W‐DEQ A were included. Exclusion criteria: twin pregnancies (included in protocol, not mentioned in paper).
Interventions	Intervention (n = 131): Women in the intervention group were contacted by mail and offered group psychoeducation in connection with fear of childbirth. After screening and randomisation (Time 0), the women and their partners in both groups separately received 3 questionnaires. The intervention method used to treat women with severe fear of childbirth was group psychoeducation with relaxation exercises. "Six group sessions were held during pregnancy (starting at mean the 28th week of pregnancy) and one session 6–8 weeks after delivery. Sessions were led by a psychologist with specialised skills in group therapy and pregnancy issues. Each group consisted of a maximum of 6 nulliparous women. The sessions (2 hours) had a fixed structure: a focused topic and a 30‐minute relaxation with mindfulness guided exercise, using a compact audio disk developed for this purpose. Every session began with the therapist setting the agenda for the coming session and the sharing of feelings and thoughts that came up after the previous session. Then there was a guided discussion on the topic of the session and the session ended with the relaxation exercise. The guided relaxation exercise took participants through all stages of delivery in a relaxed state of mind with positive, calming and supportive suggestions or alternatively, a breathing exercise. The development of the group intervention was based on experience with therapeutic group work, attachment theory, social cognitive theories and individual coping strategies. The aim of the intervention was to enhance preparedness for childbirth among nulliparous women with severe fear of childbirth. The focus of the intervention was to share the difficult emotions and fears concerning the delivery and increase the feelings of safety and trust within the participants. Another aim was to strengthen the participants’ confidence in themselves regarding childbirth and motherhood, and also to increase their knowledge of the stages of delivery." Comparator (n = 240): "those randomised to the control group received a letter in which they were advised, if necessary, to discuss their fear of childbirth in their maternity unit in primary health care."
Outcomes	Primary outcome: Psycho‐emotional and psychosocial evaluations (Edinburgh Postnatal Depression Scale (EPDS), social support, Maternal Adjustment and Attitudes (MAMA), Traumatic Events Scale (TES) and the Wijma Delivery Experience Questionnaire (W‐DEQ B)) were completed twice during pregnancy (once at mid‐pregnancy and again at late pregnancy) and then at 3 months after giving birth.
Notes	Sources of trial funding: funded with grants from the Emil Aaltonen Foundation and the Signe and Ane Gyllenberg Foundation. Trial dates: Between October 2007 and August 2009 Ethical approval: This study was approved by the Ethics Committee for Gynaecology and Obstetrics, Otology, Ophthalmology, Neurology and Neurosurgery of Helsinki University Central Hospital (376/E9/05 from 27 October 2005) and informed consent was collected from everyone who filled in any of the questionnaires. Study prospectively registered? Clinical Research Register at Helsinki University Central Hospital Number: 228/2006 and ClinicalTrials.gov ID: NTC01548131. Trial author declaration of interest: The authors report no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Women were randomised in a proportion of 1:2 in balanced blocks of 18 via sealed opaque envelopes to the intervention group and to the control group
Allocation concealment (selection bias)	Low risk	"sealed opaque envelopes"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding not possible in this kind of study. Knowledge of the allocated intervention could have an impact on outcomes.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Incomplete outcome data (attrition bias) All outcomes	High risk	W‐DEQ scores only reported for 70/131 and 124/240 women who were randomised.
Selective reporting (reporting bias)	High risk	The results are presented in the following order: maternal adjustment, childbirth experience, depressive symptoms and traumatic symptoms. However, the protocol planned to present outcomes at 3 months and 2 years but only 3 months reported.
Other bias	Low risk	Nothing to suggest any other source of bias.