Misoprostol for preventing postpartum haemorrhage

ISRCTN	ISRCTN97277056
DOI	https://doi.org/10.1186/ISRCTN97277056
Secondary identifying numbers	4.3

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Andrew Weeks
Scientific

School of Reproductive and Developmental Medicine
University of Liverpool
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 702 4240
Email	aweeks@liverpool.ac.uk

Study design	Multicentre randomised controlled parallel group dosage trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Optimising the dose of Misoprostol for the prevention of postpartum haemorrhage: a randomised trial
Study objectives	Lower doses of misoprostol produce as strong postpartum uterine contractions as 10 IU of intramuscular (IM) oxytocin
Ethics approval(s)	University of Liverpool Committee on Research Ethics approved on the 26th of June 2009 (ref: RETH000237)
Health condition(s) or problem(s) studied	Postpartum haemorrhage
Intervention	Treatment groups: 200 mcg or 400 mcg or 600 mcg sublingual misoprostol given once immediately post partum. Control group: 10 IU IM oxytocin. Observation of intrauterine pressure and vital sign for 120 minutes.
Intervention type	Other
Primary outcome measure	Montevideo units (MVU) (contractions over 10 minutes) for intrauterine pressure values over the first 15 minutes after placental delivery (Baby delivery)
Secondary outcome measures	1. MVU at 30, 60, 90 and 120 minutes 2. Pulse, blood pressure, and temperature at 30, 60, 90 and 120 minutes 3. Blood loss, measured in the 120 minutes after delivery
Overall study start date	16/08/2009
Completion date	15/09/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	60
Key inclusion criteria	1. Women who have had spontaneous vaginal delivery 2. Women with gestational age >34 weeks 3. Women who give an informed written consent 4. Aged ≥ 18 years
Key exclusion criteria	1. Women with history of Postpartum Haemorrhage (PPH) 2. Women with history of Antepartum Haemorrhage (APH) 3. Women with previous caesarean section 4. Women with 5 or more previous deliveries at over 28 weeks 5. Women who have Premature Rupture of Membranes (PROM) 6. Women with anaemia (Hb <10g/dl) 7. Women who have given birth to a baby of birth weight > 4.0 Kgs 8. Women who have induced or augmented labour with any uterotonic drugs 9. Women with multiple pregnancies 10. Women with polyhydraminos 11. Women with pre eclampsia 12. Women with infection 13. Women who do not give a written consent
Date of first enrolment	16/08/2009
Date of final enrolment	15/09/2010

School of Reproductive and Developmental Medicine

Liverpool
L8 7SS
United Kingdom

University of Liverpool (UK)
University/education

General Research Enquiries
Research Support Office
The Foresight Building
3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom

University/education

The University of Liverpool (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2011		Yes	No