Study Design and Study Population
FIDEL (FIbrinogen in DELivery) is a randomized, multicentre,
double-blind, placebo-controlled study on the efficacy and safety of a
therapeutic strategy comparing early and systematic administration of
human fibrinogen versus placebo in patients with PPH when switched from
intravenous oxytocin to prostaglandins following vaginal delivery. The
full study protocol is available in Supplement 1. The initial protocol
was published in 2016 19. The study was sponsored and
funded by the company LFB (Les Ulis, France), which holds the marketing
authorization for Clottafact® (fibrinogen concentrate). The double-blind
versus placebo research, data collection and results interpretation were
conducted by an independent organism (Euraxi France) under the closed
oversight of the scientific committee and the independent monitoring
committee.
The FIDEL study was conducted in 30 public or private tertiary care
hospitals in France. Subjects meeting the following main inclusion
criteria (age ≥ 18 years, with PPH following vaginal delivery requiring
continuous intravenous prostaglandin administration (sulprostone, at an
initial rate of 500 µg/h, according to guidelines 16),
with at least one haemoglobin (Hb) value available for the third
trimester of pregnancy) were included and randomized. The other
inclusion and non-inclusion criteria were described previously19. Given the
emergency context, consent was
obtained after brief delivery of information to the patient, or a
relative or reliable person, depending on the patient’s level of
consciousness. In all cases, as soon as possible, the patient was fully
informed about the study and asked to sign a post-inclusion consent form
to continue participating.
Funding :
The study was sponsored and funded by the company LFB (Les Ulis,
France), which holds the marketing authorization for Clottafact®
(fibrinogen concentrate). The study was concepted and performed
according to a double blind versus placebo design. Conception conduct of
the study, quality assessment, data-management, blinded data validation,
statistical management quality and paper writing were conducted under
the oversight of the scientific committee. The awarded grant included
external peer review for data collection,applicable regulation and
scientific quality.