Inhaled Oxytocin in women after birth and in nonpregnant women
Research type
Research Study
Full title
A randomized, open-label study to characterize the pharmacokinetics of inhaled oxytocin (GR121619) compared with IM oxytocin in women in the third stage of labour, and with IV oxytocin in non-pregnant, non-lactating women of childbearing potential
IRAS ID
214126
Contact name
Katarzyna Barbara Gajewska-Knapik
Contact email
Sponsor organisation
GSK R&D, Projects Clinical Patforms & Sciences
Eudract number
2016-002672-27
Duration of Study in the UK
0 years, 7 months, 5 days
Research summary
An oxytocin injection is the recommended treatment for the prevention of heavy bleeding in women who have just given birth. The pharmaceutical company GSK, in collaboration with Monash University of Australia, is developing a form of oxytocin to take via the Modified Air Inlet ROTAHALER™ dry powder inhaler device (abbreviated inhaled oxytocin) as a needle-free alternative to injections. This has the potential to save the lives of women in poorer countries, where the lack of a reliable electricity supply can prevent oxytocin injections being stored in a refrigerator.
This is the second study of inhaled oxytocin in women who are not pregnant, and the first study in women who are in labour. The study will test the safety of inhaled oxytocin, measure oxytocin concentration in blood samples, and compare this to the concentration of oxytocin after an injection.
Ten healthy non-pregnant women will receive 400 micrograms (mcg) of inhaled oxytocin and an intravenous injection of 5 International Units (IU) oxytocin, on 2 separate occasions, in GSK’s specialist clinical research unit. The study will also enrol healthy pregnant women who agree to have active management of the third stage of labour: 20 women will be randomised to receive either 10 IU of oxytocin intramuscular or 400 mcg inhaled oxytocin, during or shortly after their baby is born. This part of the study will be conducted in a maternity hospital.
Taking part in the study will not have direct benefit to the non-pregnant participants. For the pregnant women, oxytocin is a recommended treatment used in management of third stage labour in the UK. If a pregnant woman requires additional care any time during labour or after giving birth, she will receive the regular care as appropriate from the NHS.REC name
HSC REC B
REC reference
16/NI/0214
Date of REC Opinion
27 Oct 2016
REC opinion
Further Information Favourable Opinion