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.: PACTR202311776445720 Date of Approval: 06/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Medical Management of Second Trimester Missed Miscarriage using a combination of Mifepristine-misoprostol versus Misoprostol alone
Official scientific title Medical Management of Second Trimester Missed Miscarriage using a combination of Mifepristine-misoprostol versus Misoprostol alone
Brief summary describing the background and objectives of the trial ABSTRACT INTRODUCTION- Missed miscarriage in the second trimester is a common occurrence among pregnant women and complicates 0.3-5% of pregnancies. The use of medications for the management of second trimester missed miscarriage is a safe and effective alternative to dilation and evacuation. AIM- The aim of the study is to determine whether the use of mifepristone-misoprostol combination is as effective as misoprostol alone in achieving complete uterine evacuation in cases of second trimester missed miscarriage. METHODOLOGY- The study shall be a double-blind, randomised controlled trial carried out in the University of Abuja Teaching Hospital (UATH) and Kwali General Hospital. Women are eligible for enrolment if they are diagnosed with missed miscarriage in the second trimester, choose to have medical management of miscarriage and are willing and able to give informed consent. 72 participants shall be randomly assigned (1:1) to a single dose of mifepristone 200mg or an oral placebo tablet, both followed 36 hours later by 200ug of misoprostol vaginally 6 hourly for 4 doses. Randomization shall be done via a computer-based program. Participants, clinician and nurses shall be masked to study group assignment throughout the trial. The primary outcome is complete uterine evacuation using the regimen above. Primary analysis shall be done according to per protocol principle. CONCLUSION- Medical management of second trimester missed miscarriage is a safe alternative to surgical management as it is less invasive, easy and associated with fewer complications.
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 Missed miscarriage
Purpose of the trial Treatment: Drugs
Anticipated trial start date 22/11/2022
Actual trial start date 09/12/2022
Anticipated date of last follow up 22/05/2023
Actual Last follow-up date 28/09/2023
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
Recruitment status Recruiting
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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mifepristone 200mg Single dose Mifepristone 200mg given orally followed 36 hours later by vaginal misoprostol 200ug 6hourly for 4 doses 36
Control Group Calcium carbonate 250mg Single dose Calcium carbonate 250mg given orally followed 36hours later by vaginal misoprostol 200ug 6 hourly for 4 doses 36 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed with a missed miscarriage by pelvic ultrasound scan in the second trimester of pregnancy Patients who give informed consent to medical management of missed miscarriage in second trimester. Patients with known allergy to mifepristone or misoprostol Patients with coagulation disorders Patients with a previous Caesarean delivery/myomectomy Life threatening bleeding, Contraindications to mifepristone or misoprostol, Patients who do not give consent Patients who opt for alternative means of miscarriage management Patients with multiple gestation Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 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 05/12/2022 University of Abuja Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Abuja Teaching Hospital, Gwagwalada, PMB 228, FCT-ABUJA Abuja 900284 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures include; treatment success as defined by complete expulsion of the products of conception and no need for any additional medical and/or surgical intervention. 24 hours after complete expulsion
Secondary Outcome Secondary outcome measures include; intervention-complete expulsion interval, use of additional doses of misoprostol to effect expulsion, surgical intervention to complete miscarriage, use of oxytocin to aid expulsion of products of conception, side-effects of the medications used and complications of the miscarriage process such as excessive hemorrhage, retained placenta, etc. During the process of uterine evacuation, 24hours, 7 days and 21 days afterwards
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Abuja Teaching Hospital University of Abuja Teaching Hospital, Gwagwalada, PMB 228, FCT-Abuja Abuja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
RABIATU MUSA AHMED UNIVERSITY OF ABUJA TEACHING HOSPITAL, GWAGWALADA ABUJA Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rabiatu Musa Ahmed 40 Suez Crescent, Abacha Estate, Wuse zone 4, FCT-ABUJA Abuja 900284 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabiatu Musa Ahmed rabiatuahmed33@gmail.com +2348160056766 40Suez Crescent, Abacha Estate, Wuse zone 4, FCT-ABUJA
City Postal code Country Position/Affiliation
Abuja 900284 Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Rabiatu Musa Ahmed rabiatuahmed33@gmail.com +2348160056766 40 Suez crescent, Abacha estate, Wuse zone 4, FCT-ABUJA
City Postal code Country Position/Affiliation
Abuja 900284 Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Rabiatu Musa Ahmed rabiatuahmed33@gmail.com +2348160056766 40 Suez crescent, Abacha Estate, Wuse zone 4, FCT-ABUJA
City Postal code Country Position/Affiliation
Abuja 900284 Nigeria Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data with respect to results of the study shall be shared via publications, departmental presentations and scientific conferences Informed Consent Form,Statistical Analysis Plan Within 12 months of completion of the study Anyone interested
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