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.: PACTR201803003087264 Date of Approval: 13/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomised Trial of oral misoprostol versus manual vacuum aspiration for treatment of incomplete abortion in a Nigerian Tertiary hospital
Official scientific title Randomised Trial of oral misoprostol versus manual vacuum aspiration for treatment of incomplete abortion in a Nigerian Tertiary hospital
Brief summary describing the background and objectives of the trial The World Health Organization estimates that 67,000 women mostly in developing countries, die each year from untreated or inadequately treated abortion complications and is especially prevalent in low-resource settings, where abortion laws are restrictive, or when access to safe abortion services is difficult. In Sub-Saharan Africa, access to post abortion care (PAC) services, especially treatment of incomplete terminations, is a priority. One of the major advances in PAC is the use of manual vacuum aspiration (MVA) for uterine evacuation when uterine size is consistent with or fewer than 12 weeks of gestation. However, in low-resource areas, surgical methods can be difficult to access due to scarcity of trained providers, sterile surgical facilities, and or inadequate transportation to higher level centres where surgical procedures are most often performed. Research has shown insufficient use of, inadequate access to and low availability of uterine evacuation services in Nigeria despite the great need. However, medical treatment of incomplete abortion with misoprostol has been shown to be an effective alternative to MVA or sharp curettage. The aim of this study is to compare oral misoprostol with manual vacuum aspiration in the treatment of first trimester incomplete abortion at the University of Ilorin teaching hospital, Nigeria.Specific objectives are to determine the efficacy of oral misoprostol and manual vacuum aspiration in the management of first trimester incomplete abortion, To determine the safety of oral misoprostol and manual vacuum aspiration in the management of first trimester incomplete abortion, to determine the acceptability of oral misoprostol and manual vacuum aspiration in the management of first trimester incomplete abortion,to compare the efficacy, safety, and acceptability of oral misoprostol with manual vacuum aspiration in the management of first trimester incomplete abortion.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MVA manual vacuum
Disease(s) or condition(s) being studied First Trimester Incomplete abortion,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/01/2014
Actual trial start date 03/02/2014
Anticipated date of last follow up 20/09/2015
Actual Last follow-up date 20/10/2015
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised A computer-generated random numbers using Stat Trek random numbers generator (manufactured by Stat Trek) was used to allocate the women to either manual vacuum aspiration or misoprostol group. The allocation number was written on the back of an opaque sealed envelope which contained the card that beard the intervention Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral misoprostol 600mcg Single dose 600mcg oral misoprostol administered as single dose for first trimester incomplete abortione 100 Active-Treatment of Control Group
Control Group Manual vacuum aspiration Single procedure single procedure MVA using the device as a single procedure 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Open cervical os Uterine size ¿ 12 weeks Haemodynamic stability defined as: Pulse rate < 100 beat/minute, systolic blood pressure ¿ 100 mm Hg. Agreement to contact information and follow-up visit to confirm uterine evacuation and access to a functional telephone. Resident within Ilorin. No history of coagulation disorders and history of prostaglandin allergy. Ultrasound (transvaginal) report of retained product of conception. Presence of intrauterine device Signs of pelvic infection and or sepsis (defined as at least one of the following: foul smelling vaginal discharge; fever above 380C; and uterine tenderness). Patient younger than 18 years and had no accompanying adult to provide informed consent. 18 Year(s) 50 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 06/01/2014 University of Ilorin ethical research committee
Ethics Committee Address
Street address City Postal code Country
Oke-ose old Jebba road ilorin ILORIN 240243 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complete uterine evacuation At one week after treatment for incomplete abortion
Primary Outcome Complete uterine evacuation At one week after treatment for incomplete abortion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teachinghospital Okeose ilorin ILORIN 240103 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Cipla Evans Nigeria Limited Plot 6, Abimbola Way, Isolo P.M.B. 1120, Apapa, Lagos, Nigeria. Lagos 102241 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Ilorin teaching hospital Old Jebba road,oke- ose ILORIN ILORIN 240103 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Olafimihan B.B Okeose ilILOR department of Radiology UITH ILORIN 240103 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kehinde Femi Ibiyemi kfibiyemi@yahoo.co.uk +2348034205043 Obstetrics and gynaecology department UITH old Jebba road oke one ilorin
City Postal code Country Position/Affiliation
Ilorin 240001 Nigeria Honoourary consultant gynaecologist
Role Name Email Phone Street address
Public Enquiries Munir Adesola Ijaya munirijaiya@yahoo.com +2348033801565 Old Jebba road oke-ose Ilorin
City Postal code Country Position/Affiliation
Ilorin 240213 Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Kehinde Femi Ibiyemi kfibiyemi@yahoo.co.uk +2348034205043 old Jebba road oke one ilorin
City Postal code Country Position/Affiliation
Ilorin 240001 Nigeria Honoourary consultant gynaecologist
REPORTING
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