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.: PACTR201902721929705 Date of Approval: 12/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Double-blind Randomized Trial on Comparison of Intravenous and Intramuscular Oxytocin for Preventing Atonic Primary Post Partum Haemorrhage in Third Stage of Labour
Official scientific title A Double-blind Randomized Trial on Comparison of Intravenous and Intramuscular Oxytocin for Preventing Atonic Primary Post Partum Haemorrhage in Third Stage of Labour
Brief summary describing the background and objectives of the trial Primary postpartum haemorrhage (PPH), most commonly caused by uterine atony, remains a leading but preventable contributor to maternal mortality and morbidity worldwide accounting for about 25% of all maternal deaths. Although the use of oxytocin either intravenously or intramuscularly as prophylaxis is recommended in the third stage of labour, it is still unclear which of these two routes is more effective and safer due to extreme dearth of comparative studies.This trial aims to compare the efficacy and safety of intravenous and intramuscular oxytocin in preventing atonic primary postpartum haemorrhage in the third stage of labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IIO Trial
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 19/02/2019
Actual trial start date
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 232
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intravenous oxytocin group 10 IU of Oxytocin STAT (once) Once 1ml of Oxytocin will be administered as a bolus injection slowly over 2 minutes into a peripheral vein and 1ml of water for injection into the muscle. The maternal pulse rate and blood pressure will be checked every 5 minutes for 30 minutes then every 15 minutes for 1 hour 30 minutes. 116
Control Group Intramuscular oxytocin group 10 IU STAT (once) Once 1 ml of Oxytocin will be administered by inserting the needle, connected to the Oxytocin-containing 2 ml syringe, perpendicularly and deep into the vastus lateralis part of the quadriceps femoris muscle and 1ml of water for injection slowly over 2 minutes into a peripheral vein. The maternal pulse rate and blood pressure will be checked every 5 minutes for 30 minutes then every 15 minutes for 1 hour 30 minutes. 116 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy pregnant women Age of 18 years or older Term singleton pregnancy Normotensive pregnancy Spontaneous onset of labour Vaginal delivery Informed consent. Preterm gestation; Grandmultiparity; Those with previous Caesarean section or uterine surgery; Those with any other contraindication to vaginal delivery; Multiple pregnancy, Suspected fetal macrosomia Polyhydramnios; Previous history of post partum haemorrhage; Those on induction of labour; Those with medical illness like hypertention, diabetics, hepatic disease, renal disease, pre eclampsia, and coagulation disorders Antepartum haemorrhage Uterine fibroids in pregnancy. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 14/02/2019 Nnamdi Azikiwe University Teaching Hospital Ethical Committee
Ethics Committee Address
Street address City Postal code Country
49 Nnewi Onitsha Road Nnewi 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean postpartum blood loss.Maternal hypotension Within 2 hours of vaginal delivery.
Secondary Outcome Need for additional uterotonics, need for blood transfusion, need for surgical intervention, postpartum maternal anaemia, maternal shivering, maternal nausea and vomiting Within 2 hours of vaginal delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi 49 Nnewi Onitsha Road Nnewi 435001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
EMMANUEL OKAFORCHA 49 Nnewi Onitsha Road Nnewi 435001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nnamdi Azikiwe University Teaching Hospital 49 Nnewi Onitsha Road Nnewi 435001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
DR GEORGE ELEJE 49 Nnewi Onitsha Road Nnewi 435001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Okaforcha emmanuelokaforwhite@gmail.com +2348036721488 49 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries GEORGE ELEJE georgel21@yahoo.com +2348068117444 49 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria Senior Lecturer and Consultant
Role Name Email Phone Street address
Public Enquiries Chukwuemeka EZEAMA emeka.ezeama@gmail.com +2348037167284 49 Nnwi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes RESEARCH PROFORMA A DOUBLE-BLIND RANDOMIZED TRIAL ON COMPARISON OF INTRAVENOUS AND INTRAMUSCULAR OXYTOCIN FOR PREVENTING ATONIC PRIMARY POST PARTUM HAEMORRHAGE IN THIRD STAGE OF LABOUR Tick [X] or write where appropriate. 1. Code number of Patients (Randomisation code) :-------------- 2. Folder Number----------------------------- 3. Date of Admission----------------------- 4. Age--------------------------------------- 5. Parity------------------------------------ 5. LMP-------------------------------------- 6. Gestational Age (Weeks) ------------ - 7. Booking status: Booked………….;Unbooked……… 8. Vital signs (at admission): Pulse….. (b/min); BP……..mmHg 9. Vital signs (24 hr postpartum): Pulse….. (b/min); BP……..mmHg 10.Haematocrit (at admission):……..% 11. Haematocrit (48 hr postpartum):……..% 12. Route of injection……IM;…..IV 13. Postpartum blood loss………..ml 14. Additional oxytocics requirement……..YES[ ]; NO [ ] 15. Side Effects:(Tick whichever applies) Nausea…..vomiting…headaches…..dizziness…..Diastolic hypotension………Hyperpyrexia……others (specify) 16. Blood transfusion: Yes[ ]…..NO[ ]….. 17. If yes in (16) above, state number of units transfused……. 18. Surgical interventions………Manual removal of placenta [ ], Evacuation of rettained products of conception [ ], B-lynch [ ],Uterine artey ligation [ ], Hysterectomy [ ]; Others (specify) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol March 2019 to July 2019 Open. Request for data will be via e-mail to the principal investigator. The principal investigator will decide whom to give the data requested or study protocol. The principal investigator will provide the summary results within the trial registration record.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information