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.: PACTR201802003154375 Date of Approval: 27/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Misoprostol for prevention of postpartum hemorrhage
Official scientific title A randomized clinical trial of sublingual versus rectal misoprostol for the prevention of postpartum hemorrhage in low resource settings
Brief summary describing the background and objectives of the trial To compare between sublingual and rectal routes of administration of misoprostol for the prevention of postpartum hemorrhage in low risk women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Prevention of PPH
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/03/2018
Actual trial start date 31/03/2018
Anticipated date of last follow up 21/10/2018
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 (Sublingual group) 400 ug (2 tablets) of misprostol once Sublingual 300
Experimental Group Group 2 (Rectal group) 300 women to whom 400 ug (2 tablets) of misprostol once Rectal 300
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women at term in active labour admitted to delivery room, with singleton pregnancy, vertex presentations with no risk factors for postpartum hemorrhage. Grand multipara, operative vaginal delivery, previous uterine scar, contraindication to misoprostol or any risk factor for postpartum hemorrhage as multiple pregnancy, polyhydramnios and fetal macrosomia. 18 Year(s) 36 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
Yes 29/01/2018 Menoufia Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of blood loss within 2 hours after delivery
Primary Outcome postpartum hemorrhage within 24 hours
Primary Outcome the need for injectable uterotonics within 24 hours
Primary Outcome drop in Hemoglobin level after 24 hours drop in Hemoglobin level after 24 hours
Primary Outcome drug adverse effects within 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information