Objectives The aim of this research is to investigate components for adequate care at the POP-clinic. The feasibility acceptability and effectivity of POP-care (8 hospitals) will be evaluated, both quantitatively and qualitatively. Quantitative outcomes will be compared to the reference model (PROMISES(monodisciplinary)-cohort) and qualitative outcomes will be compared between the two different POP-models. The main research question is: Is the POP-clinic effective (and what is the most effective POP-model) compared to the reference model with regards to reduction in maternal psychiatric symptoms at 6 weeks postpartum compared to baseline (EPDS: Edinburg Postnatal Depression Scale)?
Study type This is a prospective multicentre research. A mixed-method quasi-experimental study design is chosen, in which we will collect quantitative as well as qualitative data.
Study population All women with confirmed intra-uterine pregnancy till 32 weeks’ gestation referred to a POP-clinic will be included after informed consent. For the comparison between the two POP-models and the reference model the relative change in EPDS score from baseline until after birth (6 weeks postpartum) is considered. With a Hedges’ d of 0.40, a power of 80% and an alpha of 0.05, 100 patients per group are needed. Accounting for clustering and non-compliance, 170 patients per group will be recruited.
Methods The different POP-models (8 POP-clinics) will be evaluated and compared mutually and to standard care (PROMISES(monodisciplinary)-cohort): cognitive behavioural therapy or referral to general practitioner). Pregnant women will be informed about the study on the moment of their first appointment at the POP-clinic. Data will be collected till 3 months postpoartum by questionnaires (e.g. psychiatric symptoms, treatment experience), data research (birth, neonatal outcomes) and interviews/ focus groups. Generalized linear mixed-model and thematic analysis will be performed.