The optimal strategy for induction of labour (IOL) in cases of prelabour rupture of membranes (PROM) with an unfavourable cervix is elusive. No study conducted in nulliparous women has shown any one induction method to be superior to any other. In this project, we seek to determine whether IOL with balloon catheter and oxytocin can (1) increase rate of delivery

We are conducting a multicentre, randomised, controlled, open-label therapeutic trial with two parallel arms on nulliparous women with unfavourable cervix showing PROM at term without spontaneous labour.

After 12 hours of PROM, women are randomly assigned to one of two study groups. One group is treated with a balloon catheter for 12 hours, with oxytocin administered after 6 hours. If the balloon is expelled earlier than 6 hours after insertion and the cervix is still unfavourable, another balloon is placed. The other group (control) is treated with 25 µg oral PGE1 every 2 hours until labour starts. After a maximum of eight administrations and a timelapse of 4 hours, if there are no effective uterine contractions, the induction is continued with oxytocin infusion and epidural analgesia if the patient requests it. A total of 520 women will be recruited in five university hospitals in France and randomised at a 1:1 ratio with stratification by study centre.

Main inclusion criteria are nulliparous women with gestational age ≥37 weeks, PROM without labour beyond 12 hours, unfavourable cervix (Bishop score

The hierarchical primary endpoints are: (1) Proportion of patients vaginally delivered

The RUBAPRO2 trial was approved by the French national agency for drug safety and committee for protection of persons involved in biomedical research on 15 September 2022. Informed written consent will be obtained from all participants.

NCT05568745.

Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.

We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.

The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).

NCT06731751.