Contact information
Type
Scientific
Primary contact
Dr Andrew Weeks
ORCID ID
Contact details
School of Reproductive and Developmental Medicine
University of Liverpool
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 702 4240
aweeks@liverpool.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4.3
Study information
Scientific title
Optimising the dose of Misoprostol for the prevention of postpartum haemorrhage: a randomised trial
Acronym
Study hypothesis
Lower doses of misoprostol produce as strong postpartum uterine contractions as 10 IU of intramuscular (IM) oxytocin
Ethics approval
University of Liverpool Committee on Research Ethics approved on the 26th of June 2009 (ref: RETH000237)
Study design
Multicentre randomised controlled parallel group dosage trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
16/08/2009
Overall trial end date
15/09/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant 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
Recruitment start date
16/08/2009
Recruitment end date
15/09/2010
Locations
Countries of recruitment
Libya
Trial participating centre
School of Reproductive and Developmental Medicine
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
University of Liverpool (UK)
Sponsor details
General Research Enquiries
Research Support Office
The Foresight Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)151 794 8727
research@liv.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The University of Liverpool (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21199290
Publication citations
-
Results
Elati A, Elmahaishi MS, Elmahaishi MO, Elsraiti OA, Weeks AD, The effect of misoprostol on postpartum contractions: a randomised comparison of three sublingual doses., BJOG, 2011, 118, 4, 466-473, doi: 10.1111/j.1471-0528.2010.02821.x.