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.: PACTR202009610896579 Date of Approval: 25/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MISOPROSTOL VERSUS MANUAL VACUUM ASPIRATION FOR THE TREATMENT OF FIRST TRIMESTER INCOMPLETE MISCARRIAGE AT UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL. A RANDOMIZED CONTROLLED STUDY
Official scientific title MISOPROSTOL VERSUS MANUAL VACUUM ASPIRATION FOR THE TREATMENT OF FIRST TRIMESTER INCOMPLETE MISCARRIAGE AT UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL. A RANDOMIZED CONTROLLED STUDY
Brief summary describing the background and objectives of the trial Miscarriage-related complications continue to make substantial contributions to maternal morbidity and mortality in Sub-Saharan Africa. Incomplete miscarriage may be associated with complications that constitute global public health challenge especially in developing countries. In order to optimize clinical management of incomplete miscarriage, misoprostol could provide an alternative to surgical intervention and this could increase access to abortion care in the environments where need for economical non-surgical treatments may be most useful. The objective of the study is to compare the efficacy, safety, and acceptability of intravaginal misoprostol with manual vacuum aspiration for the management of first trimester incomplete miscarriage.
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 Incomplete miscarriage
Purpose of the trial Treatment: Other
Anticipated trial start date 23/09/2020
Actual trial start date
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 76
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intra vaginal misoprostol 800 µg as a single dose single dose Women receiving misoprostol will be counseled on the side effects of the drug. The dose of 800µg misoprostol will be administered intravaginally in the gynaecological emergency by the research assistant who has been trained appropriately on how to insert the drug vaginally. The woman will be placed in dorsal position, under aseptic conditions and four tablets of 200 µg misoprostol (Cytotec) will be inserted into the posterior fornix of the vagina. After insertion, she will be asked to lie down for thirty minutes and will be monitored for 6 hours in the gynaecological emergency ward and then discharged 38
Control Group Manual vacuum aspiration procedure All women in this group will undergo manual vacuum aspiration for evacuation of retained product of conception by the trained researcher in the gynaecological emergency treatment room after administration of 800mg of ibuprofen and 0.5mg of ergometrine (this will not be used for hypertensive patients, 10iu of oxytocin will be used instead). Patients will be monitored for 6 hours after the procedure before they are discharged from the gynaecological emergency room. 38 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Gestational age less than or equal to twelve weeks or uterine size of less than or equal to 12 weeks’ LMP with history of vaginal bleeding and/or history of incomplete expulsion of products of conception 2) Open cervical os with minimal vaginal bleeding. 3) Ultrasound report of retained product of conception 1) Signs of severe infection (foul-smelling discharge, fever > 38o C, or pulse > 110/minute) 2) Haemodynamic instability 3) Missed abortion 4) Suspected ectopic pregnancy 5) Presence of IUCD in situ 6) Patient refusal or non consenting patients, not willing to be monitored and lack of access to functional phone 7) known contraindications to misoprostol Adult: 19 Year-44 Year 19 Year(s) 44 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 21/08/2020 University of Maiduguri Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Bama road Maiduguri 600223 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be the efficacy of misoprostol for completion of evacuation of incomplete abortion without recourse to additional surgical intervention at any point for any reason 8 days after insertion of intravaginal misoprostol
Secondary Outcome Abdominal pain 6 hours after intervention and 8 days after procedure
Secondary Outcome vaginal bleeding 6 hours after intervention and 8 days after procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Of Maiduguri Teaching Hospital Bama road Maiduguri 600223 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Anna Peter Bama road Maiduguri 600230 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anna Peter Bama road Maiduguri 600223 Nigeria self
COLLABORATORS
Name Street address City Postal code Country
Prof. Babagana Bako Bama road Maiduguri 600223 Nigeria
Prof. Hadiza Usman Bama road Maiduguri 600223 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anna Peter peter.anna616@gmail.com +2347030653312 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600223 Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Hadiza Abdullahi Usman adiusman@yahoo.co.uk +2348038780591 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600223 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries Babagana Bako babaganabako@yahoo.com +2348035997255 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600223 Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. Also individual data that underlies the result reported in the article after deidentification will be shared Study Protocol immediately following publication, and no end date open access
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