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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201105000292708 |
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Date of registration:
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02/05/2011 |
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Primary sponsor: |
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Public title:
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PROPHYLACTIC ERGOMETRIN VERSUS OXYTOCIN IN THIRD STAGE
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Scientific title:
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PROPHYLACTIC ERGOMETRINE VERSUS OXYTOCIN FOR WOMEN IN THE THIRD STAGE OF LABOUR: A DOUBLE-BLIND, RANDOMIZED TRIAL |
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Date of first enrolment:
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2011-06-01 |
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Target sample size:
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600 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201105000292708 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
simple randomization using a randomization table created by a computer software program,
sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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George
Eleje |
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Address:
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NAUTH,NNEWI,NNEWI ONITSHA ROAD,PMB 5025,
PMB 5025
NNEWI,ANAMBRA STATE,
Nigeria |
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Telephone:
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+2348068117444 |
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Email:
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georgel21@yahoo.com |
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Affiliation:
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Senior Registrar |
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Name:
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Theresa
Okoh |
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Address:
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NAUTH,NNEWI,NNEWI ONITSHA ROAD,PMB 5025,
PMB 5025
NNEWI,ANAMBRA STATE,
Nigeria |
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Telephone:
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+2348037250991 |
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Email:
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tessynkemokoh@yahoo.co.uk |
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Affiliation:
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Matron |
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Key inclusion & exclusion criteria
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Inclusion criteria: Consenting women
Women who had vaginal delivery
Exclusion criteria: Refusal of consent
Women that had Caesarean Section
Women with Antepartum haemorrhage.
Women with Pregnancy induced hypertension, chronic hypertension, eclampsia or cardiac disease in pregnancy.
Women with severe anaemia in pregnancy.
Age minimum:
18 Year
Age maximum:
45 Year
Gender:
Female
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Health Condition(s) or Problem(s) studied
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POST PARTUM HAEMORRHAGE
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Primary Outcome(s)
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1. Measured blood loss b500 mls after intervention. 2. Side effects (Headache, vomiting, increased diastolic hypertension) within 30 minutes of intervention.
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Secondary Outcome(s)
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1. Blood Transfusion 2. Additional Uterotonic agent after enrolment 3. Manual Removal of Placenta 4. Evacuation of retained products of conception 5. Hysterectomy 6. Maternal Death
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Source(s) of Monetary Support
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DR EZEAMA C
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