A phase 2 clinical trial of the PPH Butterfly, a new device to ‘turn off
the tap’ of Post-Partum Hemorrhage.
Objective: To assess the acceptability, safety and efficacy of the PPH
Butterfly, a new uterine compression device, in women with postpartum
haemorrhage (PPH). Design: A phase two clinical device trial using
matched historical controls, with accompanying grounded theory study.
Setting: UK university consultant obstetric unit. Population: women with
PPH after vaginal birth unresponsive to initial oxytocin therapy.
Outcomes were compared to historical controls matched on blood loss,
parity and type of birth. Methods: after oral consent, trained staff
used the device in additional to normal care. Main Outcome Measures: The
primary outcome was additional blood loss >1000mls.
Qualitative interviews assessed device feasibility and acceptability.
Results: Of the 57 recruits, two-thirds were primiparous and almost half
had undergone operative birth. Two percent of recruited women had
additional blood loss of over 1000mls compared to 8% of 113 controls
(adjusted odds ratio 0.13, 95% CI (0.02 to 1.09)). Women treated with
the device received significantly more additional treatments and had
higher rates of exclusive breast-feeding at discharge. There were no
serious adverse events related to the device. In 47 interviews,
participants, birth partners, clinicians and attending midwives viewed
the device positively. Clinicians found it useful to stop blood loss and
diagnose the source of bleeding. Conclusions: the PPH Butterfly is
acceptable and may have clinical benefits: it is a promising device for
PPH management. Funding: National Institute for Health Research
invention for innovation (i4i) program (II-LA-0715-200008) Keywords:
postpartum haemorrhage, childbirth, oxytocin, third stage of labour,
uterine compression. Registration: prospective ISRCTN (15452399);