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.: PACTR201812901591120 Date of Registration: 06/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title misoprostol efficiency in postpartum hemorrhage.
Official scientific title The comparison of efficiency of misoprostol used in different ways in postpartum hemorrhage.
Brief summary describing the background and objectives of the trial Serious maternal mortality is observed in the world due to postpartum hemorrhage. The aim of this study was to evaluate the efficiency of misoprostol in postpartum hemorrhage after delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied postpartum hemorrhage
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/10/2018
Actual trial start date 28/10/2018
Anticipated date of last follow up 31/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental oral misoprostol group We will give to one time oral way 3 tb misoporostol (cytotec ®) at the end of the second stage of labor, after delivery of the placenta All demographic data of the patient, gestational week, number of fetuses, location of placenta, presence of additional disease, history of the patient and family history, duration of delivery, whether episiotomy was performed, episiotomy repair time, vaginal laceration, objective measurement of blood collected in the bucket under the postpartum table, female genital mutilation, infant measurement information, prenatal and postnatal hemoglobin levels will be recorded and recorded. 100
Experimental Group Experimental sublingual misoprostol group We will give to one time sublingual way 2 tb misoporostol (cytotec ®) at the end of the second stage of labor, after delivery of the placenta All demographic data of the patient, gestational week, number of fetuses, location of placenta, presence of additional disease, history of the patient and family history, duration of delivery, whether episiotomy was performed, episiotomy repair time, vaginal laceration, objective measurement of blood collected in the bucket under the postpartum table, female genital mutilation, infant measurement information, prenatal and postnatal hemoglobin levels will be recorded and recorded. 100
Experimental Group Experimental buccal misoprostol group We will give to one time buccal way 2 tb misoporostol (cytotec ®) at the end of the second stage of labor, after delivery of the placenta All demographic data of the patient, gestational week, number of fetuses, location of placenta, presence of additional disease, history of the patient and family history, duration of delivery, whether episiotomy was performed, episiotomy repair time, vaginal laceration, objective measurement of blood collected in the bucket under the postpartum table, female genital mutilation, infant measurement information, prenatal and postnatal hemoglobin levels will be recorded and recorded. 100
Control Group Plaseco group We will give to one time oral way 1 tb plasebo (tic tac sugar ®) at the end of the second stage of labor, after delivery of the placenta All demographic data of the patient, gestational week, number of fetuses, location of placenta, presence of additional disease, history of the patient and family history, duration of delivery, whether episiotomy was performed, episiotomy repair time, vaginal laceration, objective measurement of blood collected in the bucket under the postpartum table, female genital mutilation, infant measurement information, prenatal and postnatal hemoglobin levels will be recorded and recorded. 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women between the ages of 18-40 2. Having pregnancy between 37-42 weeks 3. Women on vaginal delivery 4. Pregnant women with BMI <35 5. Nulliparity 1. Women with multiple pregnancy 2. Pregnant women with myoma 3. Pregnant women with polyhydramnios 4. Pregnant women with chorioamnionitis 5. Pregnant women with placental abnormalities 6. Pregnant women with bleeding diathesis 7. Pregnant women with caesarean 8. Pregnant women with low platelet 9. Women who do not want to participate 10. Pregnant women with allergic reactions to drug Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 28/10/2018 MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL ETTICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
RECEP TAYYIP ERDOGAN STREET MOGADISHU 12345 Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Objective measurement of blood collected in the bucket under the postpartum table, prenatal and postnatal 6th hours hemoglobin levels will be recorded. 6 hours
Secondary Outcome primary or secondary postpartum hemorrhage will be observed. 45th day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL Recep Tayyip Erdogan Street Mogadishu Somalia
FUNDING SOURCES
Name of source Street address City Postal code Country
MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN MOGADISHU Somalia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET MOGADISHU Somalia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator RECEP ERIN erinrecep@gmail.com +9053365629874 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Principal Investigator Zeina Ahmed Hirsi zeinaahmed08@gmail.com +252619551164 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass.Dr.
Role Name Email Phone Street address
Scientific Enquiries Recep Erin erinrecep@gmail.com +905335629874 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Public Enquiries Samaara Hassan samaara010@gmail.com +252615937497 Recep Tayyip Erdogan Street
City Postal code Country Position/Affiliation
Mogadishu Somalia Miss.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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