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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202510836146767 Date of Registration: 22/10/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Oral labetalol versus oral alpha methyl dopa for managing preeclampsia at the University of Maiduguri Teaching Hospital: A randomized controlled study.
Official scientific title Oral labetalol versus oral alpha methyl dopa for managing preeclampsia at the University of Maiduguri Teaching Hospital: A randomized controlled study.
Brief summary describing the background and objectives of the trial Preeclampsia is one of the hypertensive disorders of pregnancy encountered in obstetric practice especially in low and middle income countries including Nigeria. One key in management of this condition is to control blood pressure to prevent progression of the disease. Antihypertensive drugs are prescribed to such women to lower the blood pressure and prevent complications. There is insufficient data, particularly in developing countries on the recommendation of which of the two drugs to be used as first line in the management of severe preeclampsia. objective are To determine and compare if oral labetalol is equivalent to oral α-methyldopa I controlling blood pressure in women with preeclampsia. To analyse and compare the safety profile and adverse effects associated with of oral labetalol and oral α-methyldopa for control of blood pressure among women with preeclampsia. To evaluate maternal outcomes which include need for additional drugs, complications (eclampsia, abruption, etc) mode of delivery, onset of labour (spontaneous or induced) between the use of oral labetalol and methyldopa in the management of preeclampsia among the pregnant women. To assess neonatal outcome including birth weight, Apgar scores, special care baby admission following the use of oral labetalol and oral methyldopa in the management of preeclampsia among the pregnant women. To provide evidence based recommendations for health care provider on the equivalence of oral labetalol and α-methyldopa in the management of preeclampsia based on the findings.
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 Preeclampsia
Purpose of the trial Education /Training
Anticipated trial start date 06/10/2025
Actual trial start date 06/10/2025
Anticipated date of last follow up 11/05/2026
Actual Last follow-up date 11/05/2026
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Labetalol 200mg. Twelve hourly At recruiting up to delivery Alpha methyldopa arm will be started on 250mg twelve hourly while labetalol arm will be commenced on 200mg twelve hourly. The mean blood pressure at recruitment, mean reduction in blood pressure at the end of 48 hours would be documented for each participant. Satisfactory blood pressure control for the purpose of this study will be defined by attainment of blood pressure measurement of up to 130mmHg systolic and 90mmHg diastolic. After 48 hours patients with satisfactory blood pressure will continued on the same antihypertensive agents. Those with blood pressure above 130mmHg systolic and 90mmHg diastolic will either have their drugs increased up to maximum dosage of each arm or have an additional antihypertensive agent added to their regimen if not controlled. 54
Control Group Alpha methyl dopa 250mg twelve hourly From recruitment up to delivery. The mean blood pressure at recruitment, mean reduction in blood pressure at the end of 48 hours would be documented for each participant. Satisfactory blood pressure control for the purpose of this study will be defined by attainment of blood pressure measurement of up to 130mmHg systolic and 90mmHg diastolic. After 48 hours patients with satisfactory blood pressure will continued on the same antihypertensive agents. Those with blood pressure above 130mmHg systolic and 90mmHg diastolic will either have their drugs increased up to maximum dosage of each arm or have an additional antihypertensive agent added to their regimen if not controlled. 54 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Gestational age of 28weeks and above Live singleton pregnancy Both primigravida and multigravida Age group 16-40 years Contraindication or known allergy to labetalol or methyldopa Women that present with eclampsia Women with chronic hypertension, cardiac failure, asthma, diabetes mellitus Women that present in labour Women with confirmed IUFD, suspected fetal compromise. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 16 Year(s) 40 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 09/10/2025 University of Maiduguri Teaching Hospital research and ethics committee
Ethics Committee Address
Street address City Postal code Country
Bama road Maiduguri Nigeria Maiduguri PMB 1414 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be change in both mean systolic and mean diastolic blood pressure measurements achieved after a period of 48hours on the antihypertensive. At recruitment, at 48 hours and at delivery
Secondary Outcome The secondary outcomes will be side effect of the drug effects on the mother (e.g. Dizziness, headache, nausea, vomiting, depression etc.), need for additional antihypertensive, maternal complication such as eclampsia, abruption etc, mode of delivery (vaginal or abdominal), onset of labour (spontaneous or induced), terminating pregnancy on account of severe preeclampsia and neonatal outcomes (alive, Apgar scores, admission into special care baby, still born) At recruitment,at 48 hours and delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obstetrics and Gynaecology department of University of Maiduguri Teaching Hospital Bama road, Maiduguri. Borno state. Maiduguri 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Fatima Rais Umar No 4 Bala Geidam street ring road behind Maiduguri capital school. Maiduguri Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Fatima Rais Umar Bala Geidam street Maiduguri Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatima Rais fatimarais86@gmail.com +23407030602121 Bala Geidam street
City Postal code Country Position/Affiliation
Maiduguri Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Abubakar Kullima Ali kullima@yahoo.com +2348036142528 Hospital management board, Maiduguri Borno state. Nigeria.
City Postal code Country Position/Affiliation
Maiduguri Nigeria Senior lecturer and consultant Obstetrics and Gynaecology.
Role Name Email Phone Street address
Scientific Enquiries Babagana Bako babaganabako@gmail.com +23508035997255 Lagos street, new GRA Maiduguri, Borno state
City Postal code Country Position/Affiliation
Maiduguri Nigeria Senior lecturer and professor of obstetrics and Gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD generated from this Randomized controlled study comparing oral labetalol versus alpha methyl dopa for managing preeclampsia at the University of Maiduguri Teaching Hospital will be handled with strict confidentiality. All participants data will be de-identified and stored in a password protected electronic data based accessible only to the principal investigator and authorized member of research team After publication of the study results anonymized IPD May be made available upon reasonable request to qualified researchers for academic purpose only. Such request must be accompanied by a detailed proposal outlining the intended use of the data and must receive approval from UMTH health research ethics. Informed Consent Form After completing fellowship examination in 2 years . Data sharing will comply with institutional policies, ethical guidelines and applicable data protection regulations. No personally identifiable information will be released at any stage.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 30/09/2025 I used capital letters all through ORAL LABETALOL VERSUS ORAL ALPHA METHYLDOPA FOR MANAGING PRECLAMPSIA AT THE UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL: A RANDOMIZED CONTROLLED STUDY Oral labetalol versus oral alpha methyl dopa for managing preeclampsia at the University of Maiduguri Teaching Hospital: A randomized controlled study.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 30/09/2025 I used capital letters all through ORAL LABETALOL VERSUS ORAL ALPHA METHYLDOPA FOR MANAGING PRECLAMPSIA AT THE UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL: A RANDOMIZED CONTROLLED STUDY Oral labetalol versus oral alpha methyl dopa for managing preeclampsia at the University of Maiduguri Teaching Hospital: A randomized controlled study.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/09/2025 Number of participants in each group is 54 not 108. Experimental Group, Labetalol , 200mg. Twelve hourly, At recruiting up to delivery , Alpha methyldopa arm will be started on 250mg twelve hourly while labetalol arm will be commenced on 200mg twelve hourly. The mean blood pressure at recruitment, mean reduction in blood pressure at the end of 48 hours would be documented for each participant. Satisfactory blood pressure control for the purpose of this study will be defined by attainment of blood pressure measurement of up to 130mmHg systolic and 90mmHg diastolic. After 48 hours patients with satisfactory blood pressure will continued on the same antihypertensive agents. Those with blood pressure above 130mmHg systolic and 90mmHg diastolic will either have their drugs increased up to maximum dosage of each arm or have an additional antihypertensive agent added to their regimen if not controlled. , 108, Experimental Group, Labetalol , 200mg. Twelve hourly, At recruiting up to delivery , Alpha methyldopa arm will be started on 250mg twelve hourly while labetalol arm will be commenced on 200mg twelve hourly. The mean blood pressure at recruitment, mean reduction in blood pressure at the end of 48 hours would be documented for each participant. Satisfactory blood pressure control for the purpose of this study will be defined by attainment of blood pressure measurement of up to 130mmHg systolic and 90mmHg diastolic. After 48 hours patients with satisfactory blood pressure will continued on the same antihypertensive agents. Those with blood pressure above 130mmHg systolic and 90mmHg diastolic will either have their drugs increased up to maximum dosage of each arm or have an additional antihypertensive agent added to their regimen if not controlled. , 54,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/09/2025 The initial one was not accepted May be due to clarity TRUE, University of Maiduguri Teaching Hospital research and ethics committee , Bama road Maiduguri Nigeria , Maiduguri , PMB 1414, Nigeria, , 25 May 2025, +23407088111278, cmd_umth@yahoo.com, 37195_34376_4737.pdf TRUE, University of Maiduguri Teaching Hospital research and ethics committee , Bama road Maiduguri Nigeria , Maiduguri , PMB 1414, Nigeria, , 25 May 2025, +23407088111278, cmd_umth@yahoo.com, 37195_34376_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/10/2025 The initial one mistakenly stamped 2024. I reapply and had another copy . TRUE, University of Maiduguri Teaching Hospital research and ethics committee , Bama road Maiduguri Nigeria , Maiduguri , PMB 1414, Nigeria, , 25 May 2025, +23407088111278, cmd_umth@yahoo.com, 37195_34376_4737.pdf TRUE, University of Maiduguri Teaching Hospital research and ethics committee , Bama road Maiduguri Nigeria , Maiduguri , PMB 1414, Nigeria, , 09 Oct 2025, +23407088111278, cmd_umth@yahoo.com, 37195_34376_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 30/09/2025 I thought it was the main summary of the result but had understood now. After completion of the work and having presented for the fulfillment of fellowship at the West Africa college of surgeon(Obstetrics and Gynaecology faculty) a link or email and phone number will be available for easy access to the summary results. It will be shared after getting consent from the patients that participate in the form of initials via a link that will be generated.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 13/10/2025 Understood what was needed now better It will be shared after getting consent from the patients that participate in the form of initials via a link that will be generated. IPD generated from this Randomized controlled study comparing oral labetalol versus alpha methyl dopa for managing preeclampsia at the University of Maiduguri Teaching Hospital will be handled with strict confidentiality. All participants data will be de-identified and stored in a password protected electronic data based accessible only to the principal investigator and authorized member of research team After publication of the study results anonymized IPD May be made available upon reasonable request to qualified researchers for academic purpose only. Such request must be accompanied by a detailed proposal outlining the intended use of the data and must receive approval from UMTH health research ethics.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 13/10/2025 I understood better than before to answer the question It will be an open access. To be viewed by individuals with interest in obstetrics. Email and phone number will be available for further details Data sharing will comply with institutional policies, ethical guidelines and applicable data protection regulations. No personally identifiable information will be released at any stage.