A Danish study, published in BMJ Open, has reviewed the quality of written patient information on induced labour.
In most Danish hospitals, misoprostol is the first-choice drug for induction in low-risk pregnancies. Misoprostol has been associated with adverse side effects and severe outcomes for mother and child and is not registered for obstetric use in Denmark.
13 patient information leaflets from hat used misoprostol as an induction agent were included in the study.
Patient leaflets were evaluated according to a validated scoring tool (International Patient Decision Aid Standards instrument, IPDAS), core elements in the Danish Health Act, and items regarding off-label use and non-registered medication.
The outcomes measured were women’s involvement in decision-making, information on benefits and harms associated with the treatment, other justifiable treatment options, and non-registered treatment.
Analysis found that generally, the hospitals scored low on the IPDAS checklist. No hospitals encouraged women to consider their preferences.
Information on side effects and adverse outcomes was poorly covered and varied substantially between hospitals.
Few hospitals informed about precautions regarding outpatient inductions, and none informed about the lack of evidence on the safety of this procedure.
None informed that misoprostol is not registered for induction or explained the meaning of off-label use or use of non-registered medication. Elements such as interprofessional consensus, long-term experience, and health authorities’ approval were used to add credibility to the use of misoprostol.
The study concludes that patients receive very different, sometimes contradictory, information with potential ethical implications.
You can read the full study on the BMJ Open website.
BMJ Open 2016;6:e011333 doi:10.1136/bmjopen-2016-011333
Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?
Jette Aaroe Clausen, Mette Juhl, Eva Rydahl