Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK.
Cristina Fernandez TurienzoJoseph ChilcotAnnette L BrileyMary BollardKirstie CoxonPauline CrossSergio Alessandro SilverioClaire SinghPaul T SeedRachel M TribeAndrew H ShennanJane Sandallnull nullPublished in: PLoS medicine (2020)
We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan.
Keyphrases
- study protocol
- randomized controlled trial
- preterm birth
- healthcare
- clinical trial
- phase iii
- phase ii
- quality improvement
- palliative care
- open label
- low birth weight
- gestational age
- primary care
- systematic review
- polycystic ovary syndrome
- pain management
- affordable care act
- cross sectional
- emergency department
- double blind
- meta analyses
- placebo controlled
- type diabetes
- cervical cancer screening
- insulin resistance
- network analysis
- breast cancer risk