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.: PACTR202405860574489 Date of Approval: 13/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized controlled trial on the effectiveness of Metformin for prevention of Preeclampsia in Abubakar Tafawa Balewa University teaching hospital Bauchi, Nigeria.
Official scientific title A randomized controlled trial on the effectiveness of Metformin for preventing preeclampsia in Abubakar Tafawa Balewa University Teaching hospital, Bauchi Nigeria.
Brief summary describing the background and objectives of the trial BACKGROUND: Preeclampsia is a pregnancy complication that can have catastrophic consequences resulting in perinatal and maternal morbidity and mortality. Prevention of this dreaded complication will go a long way in improving pregnancy outcome in Nigeria. Metformin, though an oral euglycemic agent used in the treatment of gestational diabetes and Type 2 diabetes mellitus could have a preventives effect against preeclampsia. AIM: To determine the effectiveness of Metformin in preventing preealampsia among primigravidae attending antenatal clinic at Aubakar Tafawa Balewa University Teaching Hospital (ATBUTH) Bauchi, Nigeria. GENERAL OBJECTIVE To determine the effectiveness of metformin in the prevention of preeclampsia among primigravidae in ATBUTH Bauchi, Nigeria. SPECIFIC OBJECTIVES To determine the incidence of preeclampsia in the Metformin and control groups among primigravidae at ATBUTH during the study period. To determine the mean gestational age at onset of preeclampsia in the metformin group and compare with the control group. To determine the mean gestational age at delivery in metformin group and compare with the control group. To determine the severity of preeclampsia in the metformin group and compare with the co
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 Preeclamsia
Purpose of the trial Prevention
Anticipated trial start date 01/02/2023
Actual trial start date 01/02/2023
Anticipated date of last follow up 31/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Metformin group 500mg of Metformin daily for the first one week the 1gram for Metformin daily untill delivery. This was commence from less than or equals to 20wewks gestational age of pregnancy. For less than or equals to 20 weeks of pregnancy to delivery. 500mg of Metformin daily for the first one week the 1gram for Metformin daily untill delivery. This was commence from less than or equals to 20wewks gestational age of pregnancy. 70
Control Group Control group None None None 70 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primigravidae. Gestational age ≤ 20 weeks (from LMP or early scan). Singleton live pregnancy Primigravidae with history Diabetes Mellitus. Primigravidae with history chronic conditions such as; chronic hypertension, chronic renal disease, thyroid disease in pregnancy, systemic lupus erythromatosus. Known allergy to metformin. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 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 01/02/2023 Research and Ethics Committee ATBUTH Bauchi
Ethics Committee Address
Street address City Postal code Country
No. 1 Hospital road, off Yandoka road. Bauchi 740101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of Preeclampsia Severity of Preeclampsia Gestational age at onset of Preeclampsia Gestation age at delivery Delivery and development of preeclampsia
Secondary Outcome Neonatal Apgar score, Birth weight Abortions Eclampsia Abrupio placeante Pregnancy induce hypertension Side effects of metformin At onset of Metformin, delivery, onset of preeclamsia
Secondary Outcome Side effects of metformin From commencement of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abubakar Tafawa Balewa University Teaching hospital Bauchi. 1 Hospital Road, Off Yandoka Street, P.M.B 0117, Bauchi, Bauchi State. Bauchi 740101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Dauda Bathnna No 1 Hospital Road, Off Yandoka Street, P.M.B 0117, Bauchi, Bauchi State. Bauchi 740101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dauda Bathnna No 1 Hospital Road, Off Yandoka Street, P.M.B 0117, Bauchi, Bauchi State. Bauchi 740101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dauda Bathnna drbathnna@gmail.com +2348148025716 No 1 Hospital Road, Off Yandoka Street, P.M.B 0117, Bauchi, Bauchi State.
City Postal code Country Position/Affiliation
Bauchi 740101 Nigeria Principal investigator
Role Name Email Phone Street address
Public Enquiries Venat Dung ngoyop0437@gmail.com +2437039456646 BSADP quarters, gidan Gona. Bauchi.
City Postal code Country Position/Affiliation
Bauchi 740101 Nigeria Public enquires
Role Name Email Phone Street address
Scientific Enquiries Tiamiyu Ismail tiamiyuismail21@gmail.com +2438066967221 No 1 Hospital Road, Off Yandoka Street. Bauchi, Bauchi State.
City Postal code Country Position/Affiliation
Bauchi 740101 Nigeria Research assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Our commitment to transparency and scientific collaboration drives our intention to share de-identified individual trial participant data from this randomized control trial. Access to the IPD will be granted to qualified researchers for the purpose of further analysis and meta-research, following a formal request and approval process. This initiative aligns with our dedication to advancing scientific knowledge, fostering reproducibility, and contributing to evidence-based healthcare practices. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan 2years This data will be controlled. Data can be requested through an email sent to the principal investigator.
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