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.: PACTR202309644870215 Date of Approval: 28/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomised Controlled Trial: Intrauterine Misoprostol Versus Sublingual Misoprostol In The Prevention Of Postpartum Hemorrhage At Elective Caesarean Section At Korle Bu Teaching Hospital, Ghana.
Official scientific title Randomised Controlled Trial: Intrauterine Misoprostol Versus Sublingual Misoprostol In The Prevention Of Postpartum Hemorrhage At Elective Caesarean Section At Korle Bu Teaching Hospital, Ghana.
Brief summary describing the background and objectives of the trial Postpartum haemorrhage is a major global problem and remains a leading cause of maternal mortality in Ghana, and other sub-Saharan African countries. According to WHO, obstetric haemorrhage (antepartum and postpartum haemorrhage) accounts for more than a quarter of maternal deaths (330,000 maternal deaths) in 2015. Misoprostol is one of the drugs on the WHO model list of essential medicines and is commonly used in LMICs in the prevention of primary postpartum haemorrhage. Different routes have been recommended by the WHO for the administration of Misoprostol, however, most routes have been fraught with unwanted side effects. The aim of the trial is to determine the effectiveness of intrauterine misoprostol compared to sublingual misoprostol in the prevention of postpartum haemorrhage among women undergoing elective Caesarean section in Korle-Bu Teaching hospital. OBJECTIVES: 1. To compare the blood loss after delivery of placenta to 3 hours post-delivery (overall blood loss) between women who received 400mcg intrauterine misoprostol plus 5IU IV oxytocin and those who received 600mcg sublingual misoprostol plus 5IU IV oxytocin. 2. To compare the pre-operative and 24-hour post-operative haematocrit levels between women who received 400mcg intrauterine misoprostol plus 5IU IV oxytocin and those who received 600mcg sublingual misoprostol plus 5IU IV oxytocin. 3. To compare the need for additional PPH interventions (additional uterotonics, blood transfusion, uterine tamponade, compression sutures, artery ligation, hysterectomy, relaparotomy and admission to ICU) applied in the first 24 hours following delivery between women who received 400mcg intrauterine misoprostol plus 5IU IV oxytocin and those who received 600mcg sublingual misoprostol plus 5IU IV oxytocin 4. To compare the side effects profile of 400mcg intrauterine misoprostol plus 5IU IV oxytocin with that of 600mcg sublingual misoprostol plus 5IU IV oxytocin in the first 3 hours following administration.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IUMO STUDY
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postpartum haemorrhage
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2023
Actual trial start date 10/01/2024
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 11/04/2024
Anticipated target sample size (number of participants) 148
Actual target sample size (number of participants) 148
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FDA CT 241 Food and Drugs Authority Ghana
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intrauterine Misoprostol 400mcg stat stat dose The study group will receive 400mcg intrauterine misoprostol (Cytotec Pfizer) after 5IU IV oxytocin immediately after delivery of the placenta. The intrauterine misoprostol tablets (2 tablets of 200mcg) will be administered by the surgeon. One tablet will be placed in each cornu of the uterus after delivery of the placenta and complete removal of membranes before repair of the uterine incision. 74
Control Group Sublingual misoprostol 600mcg stat stat dose The control group will receive 600mcg of sublingual misoprostol (Cytotec Pfizer) after 5IU IV oxytocin immediately after delivery of the placenta. The sublingual tablets (3 tablets of 200mcg) will be administered by the anaesthesiologist. They will be placed under the tongue of the participant, and she will be told not to swallow or chew it. 74 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women 18 years and above Singleton gestation Gestational age between 37 weeks 0 days to 41 weeks 3 days. haemoglobin level <8g/dl antepartum haemorrhage (Placenta Previa, Abruptio placentae) multifetal pregnancy previous history of PPH polyhydramnios (AFI >25cm or DVP >8cm) large uterine fibroid (at least one nodule with size >10cm) and/or any FIGO Type 0 fibroids post-placental IUCD insertion known coagulation disorders known allergy to Misoprostol. Adult: 19 Year-44 Year 18 Year(s) 60 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 04/09/2023 Institutional Review Board Ethics Committee KBTH
Ethics Committee Address
Street address City Postal code Country
22nd Guggisberg Avenue Accra 77 KBTH Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is overall blood loss i.e., a combination of intraoperative blood loss and blood loss up to 3 hours after surgery. Intraoperative blood loss in this study will be defined as blood loss from after delivery of the placenta to the end of surgery. Intraoperative and up to 3 hours after surgery
Secondary Outcome change in the preoperative and postoperative haematocrit levels Day of surgery and 24 hours post surgery respectively
Secondary Outcome side effects profile (fever, vomiting, and shivering) within 3 hours post surgery
Secondary Outcome The need for additional PPH interventions which include additional uterotonic (Oxytocin, Ergometrine, carbetocin), tranexamic acid, uterine tamponade, compression sutures, artery ligation, hysterectomy at primary surgery, relaparotomy, and admission to ICU within 24 hours of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology Korle Bu Teaching Hospital 22nd Guggisberg Avenue Accra 77 KBTH Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Chidinma Peace Ohachenu Ital courts, Kakoo estate. East Legon hills Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self sponsored DR CHIDINMA PEACE OHACHENU ITAL COURT, KAKOO ESTATE EAST LEGON HILLS ACCRA Ghana Principal Investigator Self sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidinma Ohachenu chidinmaohachenu@yahoo.com +233246502611 C1 Ital courts, Kakoo estate East Legon Hills
City Postal code Country Position/Affiliation
Accra Ghana Specialist Obstetrics and Gynaecology Korle Bu Teaching Hospital Accra Ghana
Role Name Email Phone Street address
Scientific Enquiries B. D. R. T Annan annanben@hotmail.com 0208127176 Department of Obstetrics and Gynaecology, Korle Bu teaching hospital
City Postal code Country Position/Affiliation
Accra 77 KBTH Ghana Consultant Obstetrics and Gynaecology Korle bu Teaching Hospital Accra Ghana
Role Name Email Phone Street address
Public Enquiries Kwame Asah Opoku kasahopoku@yahoo.com 0242048236 Department of Obstetrics and Gynaecology, Korle Bu Teaching Hospital
City Postal code Country Position/Affiliation
Accra 77 KBTH Ghana Consultant Obstetrics and Gynaecology Korle Bu Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from this study may be made available to qualified researchers who have a scholarly interest in postpartum hemorrhage. PHI won't be included in the exchanged data or samples, which will be coded. Before exchanging data with the asking party, the request must be approved and any relevant contracts (such as a material transfer agreement) must be signed. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data can be requested starting from nine months after an item is published, and it will be available for up to 24 months. Extensions will be evaluated on an individual basis. Qualified researchers doing scientific research may seek access to the trial IPD; access will be granted following assessment and approval of a study proposal, statistical analysis plan (SAP), and execution of a data sharing agreement (DSA). For more information please contact chidinmaohachenu@yahoo.com.
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