Condition category
Pregnancy and Childbirth
Date applied
24/03/2010
Date assigned
13/05/2010
Last edited
30/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.liv.ac.uk/

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

  1. 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.

Additional files

Editorial Notes