Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201105000292708 Date of Approval: 02/05/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PROPHYLACTIC ERGOMETRIN VERSUS OXYTOCIN IN THIRD STAGE
Official scientific title PROPHYLACTIC ERGOMETRINE VERSUS OXYTOCIN FOR WOMEN IN THE THIRD STAGE OF LABOUR: A DOUBLE-BLIND, RANDOMIZED TRIAL
Brief summary describing the background and objectives of the trial Postpartum haemorrhage (PPH) is an important cause of maternal mortality worldwide.However, in our environment where PPH is the leading cause of maternal death, in selected patients, the benefit might outweigh the risk, and so ergometrine may be preferred.This trial therefore is aimed to determine the effectiveness and safety of ergometrine in comparison with oxytocin as conventional uterotonic agents for use in the third stage of labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ERGOT TRIAL
Disease(s) or condition(s) being studied POST PARTUM HAEMORRHAGE,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2011
Actual trial start date
Anticipated date of last follow up 31/12/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used
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 Masking/blinding used
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 Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ERGOMETRINE GROUP 0.5 mg ONCE once There will be an administration of Ergometrine intramuscularly within one minute of delivery of the baby. In women with vaginal bleeding judged by the doctor on call to be more than expected at least 10 minutes after delivery, and thought to be due to uterine atony and requiring additional uterotonic therapy, they will then be given all the routine treatment for PPH (intravenous infusion, uterot 300
Control Group OXYTOCIN GROUP 10 iu Once once There will be an administration of Oxytocin 10 iu intramuscularly within one minute of delivery of the baby. In women with vaginal bleeding judged by the doctor on call to be more than expected at least 10 minutes after delivery, and thought to be due to uterine atony and requiring additional uterotonic therapy, they will then be given all the routine treatment for PPH (intravenous infusion, uter 300
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting women Women who had vaginal delivery 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. 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 16/05/2011 NAUTHEC
Ethics Committee Address
Street address City Postal code Country
NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Measured blood loss >500 mls after intervention. 2. Side effects (Headache, vomiting, increased diastolic hypertension) within 30 minutes of intervention. Within 30 minutes of administration of intervention agent
Secondary Outcome 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 within 24 hours of admnistration of intervention agent
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
DIVINE CARE SPECIALIST HOSPITAL OTOLO ROAD NNEWI PMB 5025 Nigeria
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL(NAUTH) NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR EZEAMA C NNEWI ONITSHA ROAD AWKA PMB 5025 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR EZEAMA C NNEWI ONITSHA ROAD AWKA PMB 5025 Nigeria Hospital
Secondary Sponsor LIFE SPECIALIST HOSPITAL, LTD IKEMBA DRIVE NNEWI PMB 5025 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
DR GU ELEJE NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
PROF JI IKECHEBELU NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
DR AO IGWEGBE NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
PROF JEN OKONKWO NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
PROF NJA OBIECHINA NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
PROF JIB ADINMA NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
PROF OC IKPEZE NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
DR GO UDIGWE NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
DR BO NWOSU NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
DR CO OKAFOR NNEWI ONITSHA ROAD NNEWI PMB 5025 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator EZEAMA CHUKWUEMEKA nicemekt@yahoo.com +2348181343994 NAUTH,NNEWI,NNEWI ONITSHA ROAD,PMB 5025,
City Postal code Country Position/Affiliation
NNEWI,ANAMBRA STATE, PMB 5025 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries Theresa Okoh tessynkemokoh@yahoo.co.uk +2348037250991 NAUTH,NNEWI,NNEWI ONITSHA ROAD,PMB 5025,
City Postal code Country Position/Affiliation
NNEWI,ANAMBRA STATE, PMB 5025 Nigeria Matron
Role Name Email Phone Street address
Scientific Enquiries George Eleje georgel21@yahoo.com +2348068117444 NAUTH,NNEWI,NNEWI ONITSHA ROAD,PMB 5025,
City Postal code Country Position/Affiliation
NNEWI,ANAMBRA STATE, PMB 5025 Nigeria Senior Registrar
REPORTING
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