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.: PACTR202310863957659 Date of Approval: 12/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sublingual Misoprostol versus Manual Vacuum Aspiration in the Management of Incomplete Miscarriage at Katsina; a Multicentre Randomized Controlled Trial
Official scientific title Sublingual Misoprostol versus Manual Vacuum Aspiration in the Management of Incomplete Miscarriage at Katsina; a Multicentre Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Miscarriage is the expulsion of the fetus before the age of viability. About 10-15% of all pregnancies end in spontaneous miscarriage. It may become incomplete such that not all the products of conception are extruded and hence the need to evacuate the uterus. Miscarriage is one of the causes of maternal morbidity and mortality; and as such effective management is needed to improve uterine evacuation and prevent complications that may lead to morbidity and mortality. Manual vacuum aspiration (MVA) is the surgical method to evacuate the uterus following incomplete miscarriage. However, due to the cost, need for sterile instruments and non-availability of the instruments and skills especially in resource poor environment, the use of medical management becomes significant in order to reduce complications of incomplete miscarriage. The aim is to compare the outcome of sublingual misoprostol versus manual vacuum aspiration for management of first trimester incomplete miscarriage at Federal Teaching Hospital Katsina (FTHK) and Turai Yaradua Maternity and Children Hospital Katsina (TYMCH). The objectives are; 1. To compare the proportion of women with complete uterine evacuation following sublingual misoprostol versus manual vacuum aspiration for management of first trimester incomplete miscarriage. 2. To compare duration of vaginal bleeding in women who had medical management using sublingual misoprostol versus manual vacuum aspiration. 3. To compare the rate of genital tract infection in women who had medical management using sublingual misoprostol versus manual vacuum aspiration. 4. To compare patients’ satisfaction with the method offered in women who had sublingual misoprostol for treatment of first trimester incomplete miscarriage versus manual vacuum aspiration
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 Miscarriage
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/12/2023
Actual trial start date
Anticipated date of last follow up 17/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 170
Actual target sample size (number of participants)
Recruitment status Not yet 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Manual vacuum aspiration once once Participants with incomplete first trimester miscarriage will have manual vacuum aspiration 85 Active-Treatment of Control Group
Experimental Group Sublingual misoprostol 400ug once Participants with incomplete first trimester miscarriage will have 400ug single dose sublingual misoprostol 85
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting pregnant women who present with incomplete first trimester miscarriage who are haemodynamically stable 1. Women in shock 2. Patients with allergy to prostaglandins 3. Those with evidence of genital tract infection 4. Patients with background cardiovascular disease, sickle cell disease or bleeding disorder, liver or renal disease Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 05/04/2023 Health Research and Ethics Committee Federal Teaching Hospital Katsina
Ethics Committee Address
Street address City Postal code Country
Murtala Mohammed Way Katsina 820101 Nigeria
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 20/02/2023 Katsina State Health Research Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
IBB Way Dandgoro Katsina Katsina 820101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be proportion of women with completed uterine evacuation (completed miscarriage) after one week of treatment with MVA or single-dose sublingual misoprostol 400mcg one week after intervention
Secondary Outcome 1. To compare the duration of vaginal bleeding after the treatment offered; this will be by asking specific questions on number of days spent having vaginal bleeding, whether she is currently having vaginal bleeding and the woman’s assessment of the severity of the vaginal bleeding on the follow up day 2. To compare the rate of genital tract infection after the treatment. This will involve asking questions on foul smelling vaginal discharge, worsening lower abdominal pain and fever 3. To compare patients’ satisfaction with the treatment method using 5-point Likert scale one week after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teaching Hospital Katsina Murtala Mohammed Way Katsina 820101 Nigeria
Turai Yaradua Maternity and Children Hospital Katsina Off Hassan Usman Road Katsina 820101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nafisat Lawal Abdulsamad Murtala Mohammed Way Katsina 820101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Murtala Mohammed Way Katsina 821010 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nafisat Lawal ummasmau86@gmail.com +2348036548454 Murtala Mohammed Way
City Postal code Country Position/Affiliation
Katsina 820101 Nigeria Resident Federal Teaching Hospital Katsina
Role Name Email Phone Street address
Public Enquiries Abbas Ibrahim freeabbas17@yahoo.com +2348035170286 Murtala Mohammed Way
City Postal code Country Position/Affiliation
Katsina 820101 Nigeria HOD Obstetrics and Gynaecology Federal Teaching Hospital Katsina
Role Name Email Phone Street address
Scientific Enquiries Aisha Abdurrahman aisha_abdurrahman@yahoo.com +2348033096164 Murtala Mohammed Way
City Postal code Country Position/Affiliation
Katsina 820101 Nigeria Chairperson Health Research and Ethics Committee Federal Teaching Hospital Katsina
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article after deidentification will be shared Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years opened acess Data will be opened to fellows in obstetrics and gynaecology Request for data will be through ummasmau86@gmail.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