Randomised trial of intrapartum tractocile versus placebo in the management of fetal distress in women undergoing emergency Caesarean section

ISRCTN	ISRCTN59759835
DOI	https://doi.org/10.1186/ISRCTN59759835
Protocol serial number	N0059103677
Sponsor	Department of Health (UK)
Funder	Sheffield Teaching Hospitals (Central Campus) - UK

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Tom Farrell
Scientific

STH NHS Trust
OGN & Midwifery
Jessop Wing
Sheffield
S10 2SF
United Kingdom

Phone	+44 (0)114 226 8163
Email	tom.farrell@sth.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Fetal distress
Intervention	Intrapartum tractocile versus placebo. Added June 2008: trial abandoned and never recruited patients.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/2006
Reason abandoned (if study stopped)	Lack of resources

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	240
Key inclusion criteria	Women undergoing emergency Caesarean section.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/2004
Date of final enrolment	28/02/2006

STH NHS Trust

Sheffield
S10 2SF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan