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Background First-line treatment for prolactinomas is a medical treatment with dopamine agonists (DAs), which effectively control hyperprolactinaemia in most patients, although post-withdrawal remission rates are approximately 34%. Therefore, many patients require prolonged DA treatment, while side effects negatively impact health-related quality of life (HRQoL). Endoscopic transsphenoidal resection is reserved for patients with severe side effects, or with DA-resistant prolactinoma. Surgery has a good safety profile and high probability of remission and may thus deserve a more prominent place in prolactinoma treatment. The hypothesis for this study is that early or upfront surgical resection is superior to DA treatment both in terms of HRQoL and remission rate in patients with a non-invasive prolactinoma of limited size. Methods We present a combined randomised clinical trial and observational cohort study design, which comprises three unblinded randomised controlled trials (RCTs; PRolaCT-1, PRolaCT-2, PRolaCT-3), and an observational study arm (PRolaCT-O) that compare neurosurgical counselling, and potential subsequent endoscopic transsphenoidal adenoma resection, with current standard care. Patients with a non-invasive prolactinoma (< 25 mm) will be eligible for one of three RCTs based on the duration of pre-treatment with DAs: PRolaCT-1: newly diagnosed, treatment-naïve patients; PRolaCT-2: patients with limited duration of DA treatment (4–6 months); and PRolaCT-3: patients with persisting prolactinoma after DA treatment for > 2 years. PRolaCT-O will include patients who decline randomisation, due to e.g. a clear treatment preference. Primary outcomes are disease remission after 36 months and HRQoL after 12 months. Discussion Early or upfront surgical resection for patients with a limited-sized prolactinoma may be a reasonable alternative to the current standard practice of DA treatment, which we will investigate in three RCTs and an observational cohort study. Within the three RCTs, patients will be randomised between neurosurgical counselling and standard care. The observational study arm will recruit patients who refuse randomisation and have a pronounced treatment preference. PRolaCT will collect randomised and observational data, which may facilitate a more individually tailored practice of evidence-based medicine. Trial registration US National Library of Medicine registry (ClinicalTrials.gov) NCT04107480. Registered on 27 September 2019, registered retrospectively (by 2 months).

Objectives To compare the Optimality Index of planned birth in a birth centre with planned birth in a hospital and planned home birth for low-risk term pregnant women who start labour under the responsibility of a community midwife. Design Prospective cohort study. Setting Low-risk pregnant women under care of a community midwife and living in a region with one of the 21 participating Dutch birth centres or in a region with the possibility for midwife-led hospital birth. Home birth was commonly available in all regions included in the study. Participants 3455 low-risk term pregnant women (1686 nulliparous and 1769 multiparous) who gave birth between 1 July 2013 and 31 December 2013: 1668 planned birth centre births, 701 planned midwife-led hospital births and 1086 planned home births. Main outcome measurements The Optimality IndexNL-2015, a tool to measure ‘maximum outcome with minimal intervention’, was assessed by planned place of birth being a birth centre, a hospital setting or at home. Also, a composite maternal and perinatal adverse outcome score was calculated for the different planned places of birth. Results There were no differences in Optimality Index NL-2015 for pregnant women who planned to give birth in a birth centre compared with women who planned to give birth in a hospital. Although effect sizes were small, women who planned to give birth at home had a higher Optimality Index NL-2015 than women who planned to give birth in a birth centre. The differences were larger for multiparous than for nulliparous women. Conclusion The Optimality Index NL-2015 for women with planned birth centre births was comparable with planned midwife-led hospital births. Women with planned home births had a higher Optimality Index NL-2015, that is, a higher sum score of evidence-based items with an optimal value than women with planned birth centre births.

In deze samenvatting vindt u de belangrijkste resultaten van het Geboortecentrum Onderzoek. Met dit onderzoek is de zorg in geboorte- centra geëvalueerd. Belangrijke vragen waren: wat is precies een geboortecentrum en welke soorten zijn er te onderscheiden? Maakt de vorm verschil voor de kwaliteit van zorg en de waardering daarvan? Wat zijn de zwangerschapsuitkomsten van vrouwen die plannen te bevallen in een geboortecentrum? Hoe hebben de moeders en hun partners de zorg tijdens de bevalling ervaren? En wat kost de zorg van een geplande bevalling in het geboortecentrum in vergelijking met een geplande thuisbevalling en een geplande poliklinische bevalling.

Zwangeren met een laag risico op complicaties tijdens de bevalling kunnen kiezen of ze onder begeleiding van een verloskundige thuis of poliklinisch in het ziekenhuis willen bevallen. Op veel plekken is het nu ook mogelijk om te kiezen voor een bevalling in het geboortecentrum. Eind 2013 waren er in Nederland 23 geboortecentra. Zij hebben allemaal deelgenomen aan een wetenschappelijke evaluatie van de zorg in geboortecentra in Nederland, uitgevoerd door Erasmus MC, Jan van Es Instituut, LUMC, NIVEL, UMC Utrecht, Universiteit van Tilburg en TNO. Dit gebeurde in opdracht van ZonMw.